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This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including the end of PFAS sales in food packaging, misbranded hot dog buns, an online system for identifying foodborne illness outbreaks, and more.

FDA Updates

FDA Announces the End the Sale of PFAS in Food Packaging
February 28: The FDA announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S.  The announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S.  More information can be found here.

FDA Updates Ingredient Directory for Dietary Supplements
February 21:  FDA updated its Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements to find what the FDA has said about that ingredient and whether the agency has taken any action regarding the ingredient. The updated Dietary Supplement Ingredient Directory can be found here.  

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FDA Warning Letters

• Imported Food: FDA issued a warning letter to Indian Groceries and Spices, Inc. of Chicago, IL for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported spices.
• Dietary Supplements: FDA issued a warning letter to Pacific BioLogic Co. alleging that its products are misbranded and unapproved new drugs and they violate Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements.
• Misbranded Hot Dog Buns:  FDA issued a warning letter to Aunt Millie’s Bakeries alleging that its hot dog buns are misbranded because the label did not declare that it contains sesame which is a major food allergen.
• Adulterated Food:  FDA issued a warning letter to Lucky L.T. Co., Inc. alleging that its noodle products were prepared, packed, or held under insanitary conditions.
• Adulterated Animal Feed:  Pursuant to a complaint involving the death of cattle from consuming non-medicated animal feed, FDA inspected and issued a warning letter to Progressive Nutrition after finding that its product contained excessive levels of non-protein nitrogen.

A database of warning letters can be found here.

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USDA Updates

FSIS Releases 2023 Foodborne Illness Outbreak Investigations Report
February 23: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released a summary of outbreaks investigated during FY 2023. This report summarizes outbreaks investigated by FSIS during FY 2023 and includes information on pathogens, implicated sources, illnesses, and lessons learned from outbreak investigation after-action reviews.  More information about outbreaks investigated by FSIS, previous annual summary reports and resources can be found on the FSIS website.

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Other Articles of Interest

Wisconsin Launches Online System for Identifying Foodborne Illness Outbreaks
February 2:  The Wisconsin Department of Health launched a system to help people report foodborne illnesses to identify outbreaks more quickly. Through an online survey, the system allows people who suspect their illness might be from eating or drinking something contaminated to report symptoms, recent food items eaten, and places visited before becoming sick.  The online survey can help officials identify a source of contamination and learn more about water and food-related illnesses.  More information can be found here.

USDA Strengthening Organic Enforcement Rule to go into Effect
February 20: The USDA Strengthening Organic Enforcement (SOE) Rule goes into effect on March 19, 2024.  The rule is meant to fortify the integrity of USDA organic products.  Businesses across the supply chain, including manufacturers and retailers, must adjust their procedures and practices to comply with the updated rule. The SOE Rule calls for more rigorous certification practices for various types of businesses, such as importers, exporters, brokers, traders, and storage facilities. Businesses that aggregate, cull, package, repackage, or store USDA organic products must now obtain certified organic status. The certification process involves completing an application, submitting documentation, an on-site inspection, and technical review.  The SOE Rule also calls for a mandatory electronic National Organic Program (NOP) Import Certificate for any organic product entering the US.  Businesses must create or update an Organic Systems Plan (OSP) to comply with the rule.  More information can be found here.

Family Dollar to Pay Millions of Dollars for Rodent Infestation
February 27:  Family Dollar Stores LLC was fined $41.675 million for holding food, drugs, medical devices, and cosmetics under unsanitary conditions related to a rodent infestation in the largest ever monetary criminal penalty in a food safety case. The plea agreement requires Family Dollar and Dollar Tree to meet corporate compliance and reporting requirements for three years. The rodent infestation was first reported in August 2020, and by January 2021, the company was aware that the unsanitary conditions violated the Federal Food, Drug, and Cosmetic Act.  The company continued to ship products from the warehouse until January 2022, when an FDA inspection revealed the extent of the infestation.  More information can be found here.

This Regulatory Update covers information from February 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including regulations related to color additives, undetected nanoplastics found in bottled water, proposed changes to the federal hemp policy, and more.

FDA Updates

FDA Invites Comments on Petitions Seeking to Amend Food and Color Additive Regulations
January 11: FDA has filed a food additive petition and a color additive petition, submitted by Environmental Defense Fund, et al., on December 21, 2023, proposing that food and color additive regulations be amended to remove four specified solvents – Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene. The Petitioners claim that these substances have been found to induce cancer in humans or animals and are not safe pursuant to the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Comments must be submitted by March 11, 2024. More information about the color additive petition can be found here and more information about the food additive petition can be found here.

FDA Seeks Applications for Kratom HAP Study
January 16: The FDA announced a grant opportunity for applications to support the development, implementation, and evaluation of a human abuse potential (HAP) study on the use of botanical kratom. Addressing the use of botanical Kratom is a priority as the FDA works to characterize its abuse potential and subjective effects, given the absence of published literature and clinical evaluations despite increased human use. This HAP study will generate important findings related to the safety of kratom that will help researchers, scientists, and individuals using or considering the use of kratom.  The deadline for submitting applications is March 18, 2024. More information can be found here.

FDA Considers Change of Final Guidance Comment Period; Issues Draft Report on Best Practices for Guidance
January 5: The FDA is seeking comments on whether to issue more guidance as final for immediate implementation without first undergoing a formal notice and comment period. The FDA announced the availability of a draft report entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” This draft report responds to the Consolidated Appropriations Act of 2023, which directed FDA to update its 2011 guide on best guidance practices and issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, as well as a plan for implementing such best practices. Written comments on the draft report and plan must be submitted by March 4, 2024. More information can be found here and here.

Revised Draft Guidance Published on Hazard Analysis and Preventive Controls for Human Food
January 30: The FDA announced the availability of a revised draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry”. This guidance, when finalized, will explain FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under the rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The FDA revised the draft Introduction and draft Appendix 1 “Known or Reasonably Foreseeable Hazards” to address comments submitted on drafts that were made available in 2016. Comments on the draft Guidance will be accepted until June 3, 2024. More information can be found here.

Amended Color Additive Regulations for Jagua Blue Go into Effect
January 23: The FDA amended the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice. The final rule went into effect on December 4, 2023. More information can be found here.

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FDA Warning Letters

A database of warning letters can be found here.

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USDA Updates

FSIS Highlights Key Achievements in 2023
February 2: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released its key accomplishments for 2023 that protected public health through food safety. Among the accomplishments are meeting consumer expectations on labeling claims, strengthening the food supply chain, raising consumer awareness of food safety, and developing a new strategy to target salmonella in poultry. FSIS continues to modernize inspection systems and operations to enhance efficiencies without compromising food safety. More information can be found here.

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Other Articles of Interest

FDA CORE Network Releases Annual Report on Foodborne Outbreaks
January 8: The FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.  In 2022, CORE evaluated 65 incidents of foodborne outbreaks, responded to 28 incidents, and issued advisories for 11 incidents.  The 2022 numbers were up slightly from 2021.  More information can be found here.

California Widens the Gap between State and Federal Food Regulations
January 12: California Governor Newsome signed House Bill 418 into law in October 2023, Potassium Bromate, Propylparaben, and Red Dye No. 3. The bill has met resistance from federal regulators and industry trade groups. Manufacturers and industry trade associations are concerned that the law moves food regulations in the U.S. further away from a uniform regulatory framework under the FDA, and toward a fragmented model of contrasting state regulations. States are taking an increasingly active role in food safety regulations ahead of federal regulators, as seen by not only with the passage of HB 418, but also with state regulation of PFAS substances in food. More information can be found here.

Undetected Nanoplastics Found in Bottled Water
January 19: A peer-reviewed study, published in the journal Proceedings of the National Academy of Sciences, is the first to evaluate bottled water for the presence of “nanoplastics” — plastic particles under 1 micrometer in length, or one-seventieth the width of a human hair. The findings show that bottled water could contain up to 100 times more plastic particles than previously estimated. Earlier studies only accounted for microplastics, or pieces between 1 and 5,000 micrometers. According to the study, a one-liter bottle of water contains about 240,000 plastic fragments on average and many of those fragments have historically gone undetected, suggesting that health concerns linked to plastic pollution may be underestimated. Nanoplastics pose a greater risk to human health than microplastics because they are small enough to penetrate human cells. The study’s co-authors invented a new microscopy technique to identify individual nanoparticles. They found 110,000 to 370,000 tiny plastic particles in each liter and 90% of them were nanoplastics. The International Bottled Water Association released a statement saying that the study’s methodology needs to be fully reviewed by the scientific community and that there is no scientific consensus on the potential health impacts of nanoplastic and microplastic particles.

California Proposes Changes for Chemical Warnings
January 11: California may soon change the requirements for warning consumers about chemicals that may cause cancer or reproductive harm. The California Office of Environmental Health Hazard Assessment (OEHHA) held a quasi-legislative hearing on proposed rulemaking to amend the Proposition 65 short-form warning requirements. Proposition 65 requires businesses with 10 or more employees to provide a “clear and reasonable” warning before exposing individuals in California to any listed chemical that may cause cancer or reproductive harm. Companies can currently comply with Proposition 65 by warning of the potential harm without identifying a specific chemical. The proposed changes would require the listing of at least one Proposition 65 chemical for each exposure pathway. Compliance costs for the proposed regulatory changes would be significant. If OEHHA adopts the new regulatory changes, companies will have a two-year compliance period which raised concerns about insufficient time to implement compliance measures. More information can be found here.

HHS Recommends Lower Scheduling Tier for Marijuana
January 12: In response to President Biden’s order to federal officials to reevaluate marijuana’s legal status, the U.S. Department of Health and Human Services (HHS) conducted a review of marijuana’s potential medical uses and public health risks. HHS concluded that marijuana has a currently accepted medical use and recommended that it be moved from Schedule I to Schedule III under the Controlled Substances Act. HHS submitted its findings and recommendations to the U.S. Drug Enforcement Administration (DEA) who will have the final say. DEA will have to consider several factors including the potential for abuse, public health risks, psychic or physiological dependence liability, and whether the U.S. can move cannabis to a lower scheduling tier and still meet international treaty obligations.

Hemp Industry Proposes Changes to Federal Hemp Policy
January 3: A coalition of hemp industry organizations unveiled proposed changes to federal hemp policy they say would improve consumer safety and mitigate some of the burdensome regulations that have been in place since Congress legalized hemp in 2018. The proposal comes after Congress extended the lifespan of the 2018 Farm Bill by one year, leaving in place several policies that industry stakeholders seek to change. Among the policies supported by the coalition are bills H.R. 1629 and S. 2451 that would direct the FDA to regulate consumable products that include CBD under the Federal Food, Drug and Cosmetic Act. The group is calling on Congress to develop a framework to preempt state laws that criminalize hemp products. They also want Congress to mandate that hemp plants be deemed compliant if they contain no more than 1% total THC. The group also proposed reducing the role law enforcement plays in hemp regulations and remanent removal of a USDA rule requiring hemp processors and growers test their products at a laboratory with DEA certification.

New FDA Website for Foods Program Regulations
January 26: The FDA announced a new website listing regulations it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later date. The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024. More information can be found here.

FDA Regulatory Trends for 2024
February 2: The FDA is likely to pay more attention to chemical risks, allergen thresholds and enforcement of the Food Safety Modernization Act in 2024. More information can be found here.

Raw Milk Bill Proposed in Wisconsin
January 5: Senate Bill 781 was introduced in the Wisconsin legislature to reform the regulation of raw milk in the state. The bill was assigned to the Senate Committee on Agriculture and Tourism. SB 781 allows a milk producer to receive a license from DATCP to sell unpasteurized dairy products that are processed on the farm premises to consumers through delivery, at retail stores, or directly from a dairy farm. Under the bill, a milk producer who has a license to sell unpasteurized dairy products is not required to obtain a milk producer license, a grade A permit, or a butter maker or cheesemaker license if the milk producer does not send any milk to a dairy plant and sells only unpasteurized dairy products processed on farm premises. To receive a license to sell unpasteurized dairy products, a milk producer must test for several bacteria and coliform and standard plate counts, provide results from tests performed by a licensed veterinarian that show that the cows used to produce the unpasteurized dairy products do not have tuberculosis or brucellosis, and show proof of training in raw milk safety. In addition, DATCP must conduct an on-site inspection of the milk producer’s processing plant. More information can be found here.

Wisconsin Launches Online System for Identifying Foodborne Illness Outbreaks
February 2: The Wisconsin Department of Health launched a system to help people report foodborne illnesses to identify outbreaks more quickly. Through an online survey, the system allows people who suspect their illness might be from eating or drinking something contaminated to report symptoms, recent food items eaten, and places visited before becoming sick. The online survey can help officials identify a source of contamination and learn more about water and food-related illnesses. More information can be found here.

FDA Withdraws Guidance on Enforcement Approach to Human Food with Chlorpyrifos Residues
February 5: The FDA is withdrawing a 2022 guidance document entitled “Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry”, following a decision by the 8th Circuit Court of Appeals to vacate an EPA final rule that revoked all tolerances for the pesticide chemical chlorpyrifos. The guidance was intended to explain FDA’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired pursuant to the EPA final rule, which is now void. More information can be found here.

Illinois Seeks to Ban Certain Food Additives in Candy and Soda
January 31: SB 2637 was introduced in the Illinois State Senate that would ban food additives brominated vegetable oil, potassium bromate, Propylparaben, and red dye no. 3 in candy, soda and other foods produced or sold in Illinois. These are the same chemicals recently banned in California. It is unclear at this time whether the legislation would pass the General Assembly. If passed, the bill would go into effect on January 1, 2027. Violators could face a penalty of $5,000 to $10,000 per violation. More information can be found here.

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Lawsuits

Health-Ade Sued Over Alleged PFAS in Kombucha
January 11: A proposed class action lawsuit was filed in the US District Court for the Southern District of New York (Case No. 7:24-cv-00173) alleging that Health-Ade LLC deceptively markets kombucha as “health” products despite the presence of PFAS chemicals in its kombucha. The plaintiff alleges that testing by an independent laboratory revealed PFAS substances in Kombucha Ginger Pineapple Belly Reset and four other Health-Ade kombucha products.

Mondelez Faces Lawsuit Over Sustainability Labels
January 30:  The maker of Oreo cookies and one of the world’s largest snack and chocolate companies, Mondelez International Inc., has been accused of allegedly misleading consumers about its products being environmentally and socially responsible.  A consumer filed a proposed class action lawsuit the U.S. District Court for the Northern District of California against Mondelez claiming that the company “blatantly greenwashes its products in order to increase its own sales and deceptively earn the goodwill and support of the public”. According to the complaint, Mondelez’s labels state its cocoa is 100% sustainable, certified, or supports farmers but the company allegedly pays low wages to cocoa farmers resulting in child and slave labor.  The chocolate industry also contributes to deforestation in the Ivory Coast. More information can be found here.

Crystal Light “No Artificial Flavors” Label Lawsuit Dismissed
January 29: A proposed class action brought by a consumer of Crystal Light, alleging Kraft Heinz Co. deceptively conceals artificial flavors in its drink mixes, has ended after the parties filed a joint stipulation for its dismissal. The plaintiff had alleged that di-malic acid acts as a flavor in the drink mixes and that the “no artificial flavors” label statements could deceive consumers. Kraft argued that the substance is a flavor enhancer and disclosure is not required.

Dancer Dies from Allergic Reaction After Eating Mislabeled Cookies
January 25: A professional dancer with a peanut allergy, died when she suffered a severe allergic reaction to a Vanilla Florentine cookie from Stew Leonard’s, a grocery store chain in Connecticut. According to attorneys for the dancer’s family, the allergic reaction was so severe that an EpiPen was not effective. The cookie’s label did not disclose that the cookie contained peanuts. The grocery store chain CEO stated that the store was not informed by the cookie manufacturer that the ingredients were changed to include peanuts. The bakery that produced the cookies said it updated the grocery store chain last summer. Legal action is expected to be brought on behalf of the dancer’s estate. More information can be found here.

Mott’s Hit with Lawsuit Over Citric Acid in Bloody Mary Mix
January 23: A proposed class action was filed in the U.S. District Court for the Southern District of California alleging that Mott’s LLP falsely labels its Mr. & Mrs. T Bloody Mary Mix as containing no preservatives, despite containing the additive citric acid. The lawsuit contends the product’s label claim is misleading because citric acid is a preservative regardless of whether it is added for a separate purpose. More information can be found here.

This Regulatory Update covers information from January 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including draft guidance on menu labeling, PFAS found in food processing wastewater, a sustainability lawsuit for seafood, and more.

FDA Updates

FDA’s Revocation of Partially Hydrogenated Oils in Foods Goes into Effect
December 14: On August 9, 2023, the FDA published a direct final rule amending regulations to no longer provide for the use of partially hydrogenated oils (PHOs) in food, due to the FDA’s conclusion that PHOs are no longer generally recognized as safe (GRAS). The rule also revokes prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns. This rule went into effect on December 22, 2023. More information can be found here.

FDA Issues Draft Guidance on Menu Labeling
December 14: The FDA announced the availability of a draft guidance for industry entitled “Menu Labeling: Supplemental Guidance for Industry (Edition 2).” The draft guidance, when finalized, will update existing guidelines to address the voluntary declaration of added sugars and the voluntary declaration of nutrition information for menus on third-party platforms. Comments on the draft Guidance will be accepted until February 12, 2024. More information can be found here.

FDA Information Collection Activities Announced for Food Allergen Labeling and Reporting
December 8: FDA is inviting comments on food allergen labeling and reporting. This information collection solicits comments associated with statutory provisions applicable to ingredients derived from major food allergens. The respondents to this collection of information are manufacturers and packers of packaged foods sold in the U.S. subject to the labeling requirements and prohibitions found in section 403 of the Federal Food, Drug, and Cosmetic Act. Written comments on the collection of information are due by February 6, 2024. More information, and instructions on how to submit comments, can be found here.

FDA Opens Voluntary Qualified Importer Program Application Portal for FY2025
December 15: The FDA announced it will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2025. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the U.S. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program. The portal will remain open through May 31, 2024. More information can be found here.

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FDA Warning Letters

CBD & THC: The FDA issued a warning letter to a company in Colorado for concern that consumers may confuse their products with traditional foods, increasing the risk of unintended consumption of cannabidiol (CBD) and Delta-8 Tetrahydrocannabinol (Delta-8 THC). The FDA’s review determined that the company’s “Active CBD Oil Infused Coffee,” “Active CBD Oil Gummies,” “CBD Living Water,” and “Strain Snobs™ Delta-8 Plant-Based Gummies” products offered for sale on the company’s webpages are adulterated because they contain an unsafe food additive.

A database of warning letters can be found here.

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USDA Updates

USDA Proposes Exemptions for Classifying Genetically Modified Plants
December 27: The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) reopened the comment period on a proposal to add five additional exemptions to plant modifications that could be achieved through conventional breeding. According to APHIS, these types of genetic modification would be exempt from regulations concerning the movement of organisms modified or produced through genetic engineering and would reduce the regulatory burden for developers of certain plants modified using genetic engineering that are not expected to pose plant pest risks greater than the plant pest risks posed by plants modified by conventional breeding methods. The comment period runs until January 19, 2024. More information can be found here.

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Other Articles of Interest

Update on FDA Reorganization Proposal
December 13: As previously reported, FDA announced it would develop a proposal for a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. These proposed changes will strengthen the agency’s ability to oversee and protect the human food supply and other products it regulates. The proposed reorganization and modernization package includes:

• Making the FDA’s HFP and product Centers solely responsible for receipt, triage and closing consumer and whistleblower complaints.
• Renaming ORA as the Office of Inspections and Investigations (OII).
• Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues.
• Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office proposed as the Office of Regulatory and Emerging Science that will strengthen support of regulatory science and preparedness research efforts.
• Creating an Office of Enterprise Transformation.

The FDA completed the proposed reorganization package in December 2023, and it is currently under external review. The FDA hopes implementation will occur sometime in 2024. More information can be found here.

Agencies Propose Draft National Strategy to Reduce Food Loss and Waste
December 4: The FDA, USDA and EPA collaboratively released a draft national strategy that aims to reach the national goal of reducing food loss and waste in the U.S. by 50% by 2030. The draft National Strategy for Reducing Food Loss and Waste and Recycling Organics identifies opportunities to reduce food loss and waste across the entire supply chain. The public is invited to comment on the proposed national strategy. EPA extended the original public comment period to February 3, 2024. Comments can be submitted through Regulations.gov, Docket ID No. EPA-HQ-OLEM-2022-0415. More information can be found here.

FDA Responds to Petition on Nutritional Labeling of D-tagatose
December 14: The FDA issued a supplemental response to the citizen petition dated April 18, 2018, from Bonumose, Inc., regarding the percent Daily Value (%DV) declaration for added sugars for products containing D-tagatose. The FDA concluded that it is premature to finalize an overarching strategy for presenting %DV on the Nutrition Facts label for all sugars metabolized differently than traditional sugars. Many of these sugars are in the early stages of development, and FDA currently has limited information regarding the range or uniformity of the caloric values for other sugars that are metabolized differently than traditional sugar. More information can be found here.

Appeals Court Gives Nestle Glucose Control Drink False Advertising Suit a Boost
December 13: A federal appeals court ruled that Nestle consumers can pursue claims that the company deceptively markets Boost Glucose Control drinks as capable to control and manage blood sugar levels. The class action suit, Horti v. Nestle Healthcare Nutrition, Inc., No. 22-16832 (9th Cir.), challenged the “Glucose Control” product name and label statements “helps manage blood sugar” and “Designed for people with diabetes.” The court said the plaintiffs sufficiently alleged that the labels and placement alongside diabetes products are likely to make consumers think Boost drinks will have a positive effect on diabetes and blood sugar level. The Court’s unpublished opinion can be found here.

PFAS and Other Contaminants Found in Food Processing Wastewater
December 12: U.S. Geological Survey research revealed contaminants, including per- and polyfluoroalkyl substances (PFAS) were found in food process wastewater, raising concerns about environmental impacts. The research highlights the importance of continuous monitoring and the need for more comprehensive studies to fully understand the scale and impact of contaminants like PFAS coming from food processing facilities. More information about the study can be found here.

FDA Faces Growing Pressure to Ban Red Dye from Foods and Beverages
December 7: FDA is facing growing pressure to take action against red dye in foods and beverages. Activists say red dye in foods and beverages may cause cancer and other health problems, including hyperactivity and restlessness in children. The Center for Science in the Public Interest, a non-governmental advocacy group, recently sent out a letter urging people to sign a petition to ban red dye in food, dietary supplements and medications. More information can be found here.

Kratom Industry Calls on FDA to Crack Down on Bad Actors
December 28: The American Kratom Association (AKA) is calling on the FDA to properly regulate Kratom products. The regulatory status of kratom in the U.S. is currently uncertain because of the absence of laws and regulations covering its marketing and sale. However, products prepared from kratom leaves, such dietary supplements and food additives, are available in the U.S. through the Internet and at brick-and-mortar stores. Kratom has been historically used to lessen the severity of pain, coughing, anxiety and depression, opioid use disorder, and opioid withdrawal. According to the AKA, the FDA’s lack of regulation of kratom is putting consumers at risk. The AKA is concerned about the lack of prosecution by the FDA of vendors who market kratom products with illegal therapeutic claims, and the increased marketing of super-concentrated kratom products that do not provide adequate labeling for consumers. Currently the Kratom Consumer Protection Act or KCPA is pending before the U.S. Congress and the states, and is intended to resolve this issue of false labeling claims and unsafe products. More information can be foundhere.

New PFAS and Food Packaging Laws Go into Effect in Colorado
December 28: On January 2024, new laws aimed at clean air, reducing water pollution , and trash, and protecting consumers went into effect in Colorado. House Bill 22-1345, passed in 2022, bans PFAS in eight product categories including food packaging by January 1, 2024. The bill also requires the state to purchase only PFAS-free products and requires companies to disclose on cookware product labels if it contains PFAS. A ban on single-use plastic bags, polystyrene cups and to-go containers enacted by HB21-1162 also goes into effect on January 1st, as well as new label standards to help consumers identify what is compostable.

Minnesota’s Ban on PFAS Chemicals in Food Packaging Begins January 1, 2024
December 14: A ban in Minnesota on PFAS chemicals in food and beverage packages goes into effect on January 1, 2024. According to the Minnesota Pollution Control Agency, Minnesota’s law is far-reaching, allowing no exemptions, no minimum limit for PFAS and no cap to potential fines. The law applies to containers used by restaurants and food service operators as well as packaged food and beverages sold at retail stores. More information can be found here.

WanaBana Faces Lawsuit Over Lead in Applesauce Pouches
December 22: A consumer has filed a proposed class action lawsuit in the U.S. District Court for the Southern District of New York against WanaBana following the recall of the company’s cinnamon-flavored applesauce pouches containing high levels of lead. WanaBana also faces a proposed class suit by a North Carolina family that alleges their child was found to have significantly elevated blood lead levels. More information can be found here and here.

Red Lobster Sustainability Deception Lawsuit Advances
December 20: A proposed class action lawsuit was filed against restaurant chain Red Lobster in U.S. District Court for the Central District of California alleging that it deceives customers into believing some of its seafood products are sustainable when they may be sourced from fisheries that use environmentally harmful practices. The suit challenges Red Lobster’s marketing claims, including menu statements, that its products are “seafood with standards”, “sustainable” and “sourced to the highest standards.” The Court denied Red Lobster’s motion to dismiss and ruled that the plaintiff’s evidence was sufficient for the lawsuit to proceed. More information can be found here.

This Regulatory Update covers information from December 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including a proposed ban of brominated vegetable oil, new draft guidance on allergens and acidified foods, a raw milk bacteria outbreak, and more.

FDA Updates

Listing of Jagua Blue Color Additive Exempt from Certification – Final Rule
November 3: FDA is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora). The final rule is effective December 4, 2023.  Objections and requests for a hearing on the final rule must be submitted by December 4, 2023.  More information can be found here.

FDA Proposes to Ban Brominated Vegetable Oil in Food
November 2: The FDA proposed to ban brominated vegetable oil (BVO) previously used in soft drinks. BVO was authorized for use in small amounts.  However, after further study, FDA concluded that BVO use in no longer safe due to potential adverse health effects linked to thyroid, heart and liver issues. The proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. Written comments on the proposed rule must be submitted by January 17, 2024. More information can be found here.  The proposed rule and information on how to submit comments can be found here.

FDA Files Food Additive Petition from Kerry Ingredients and Flavours Ltd
October 13: The FDA filed a petition submitted by Kerry Ingredients and Flavours Ltd. (“Kerry”) proposing that food additive regulations be amended to provide for the safe use of vitamin D₃ as a nutrient supplement in powdered drink mixes added to water or carbonated water, excluding drinks or drink mixes that are specially formulated or processed for infants.  Kerry submitted the petition on April 26, 2023. More information can be found here.

FDA Information Collection Activities Announced for Recall Regulations
October 13: FDA is inviting comments on FDA Recall Regulations pertaining to the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents.  Written comments on the collection of information are due by December 12, 2023.  More information can be found here.

FDA Information Collection Activities Announced for Food Canning Establishment Regulations
October 12:  FDA is inviting comments on registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers.  The respondents to this information collection are commercial processors and packers of acidified foods and thermally processed low-acid foods in hermetically sealed containers. Written comments on the collection of information are due by November 13, 2023.  More information can be found here.

FDA Released New Draft Guidance on Food Allergens and Acidified Foods
October 3:  As previously reported, FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens.  The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods. Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.  Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices. Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers or cabbage that have an overall pH of 4.6 or below) and it explains how these manufacturers can use procedures, practices and processes that they have established to meet requirements in the acidified foods regulations.  Comments on the draft guidance must be submitted by March 25, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here.

FDA Updates Food Traceability FAQ
October 2:  The FDA has updated its Food Traceability FAQ to provide additional information about the FDA’s Product Tracing System and explain how the agency intends to conduct initial inspections beginning in 2027.  The Food Traceability Final Rule was published in November 2022, establishing traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List.  The FDA is developing additional resources and offering technical assistance to help stakeholders come into compliance. The FDA also established a compliance date of January 20, 2026 to allow those subject to the rule time to come into compliance.

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FDA Warning Letters

Unapproved New Drugs: FDA issued a warning letter to Day Light Nutrition alleging that its Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

A database of warning letters can be found here.

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USDA Updates

FSIS Examining “Raised Without Antibiotics” Marketing Claim
October 9:  The U.S. Food Safety Inspection Service (FSIS) and the Agricultural Research Service (ARS) are commencing a new exploratory sampling program to assess whether antibiotics residues are detected in cattle intended for the “raised without antibiotics” market.  This sampling program is part of the USDA’s multi-step effort aimed at strengthening the verification of animal-raising claims.  More information can be found here.

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Other Articles of Interest

FDA Developing Front-of-Package Labeling System
October 17:  The FDA published the “Catching Up with Califf”: “Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling,” by Robert M. Califf, M.D., Commissioner of Food and Drugs.  The FDA continues to work to develop a front-of-package labeling system to quickly communicate and provide certain nutrition information to consumers which “has the potential to be one of the most momentous changes to food labeling since the Nutrition Facts label.” The FDA is currently conducting consumer research to understand responses to various elements of a front-of-package labeling system. The results of this research will be used by the FDA to consider approaches to take as part of a proposed rule for public comment.  On November 16, 2023, the Reagan-Udall Foundation for the FDA will host a virtual public meeting to hear directly from stakeholders.  More information on the session is available on the Foundation’s web site and interested parties should register to attend.  More information about front-of-package nutrition labeling can be found here.

California’s Red Dye No. 3 Food Coloring Ban Puts Pressure on FDA to get off the Sidelines
October 17:  There is new pressure on the FDA to take action on the synthetic food coloring, red No. 3, after California became the first state to pass a law to ban it.  While public health advocates are pressuring FDA to remove red dye from the food supply nationwide, manufacturers are pushing back.  According to a letter from the National Confectioners Association (“NCA”) to FDA, the California ban would create a patchwork of state requirements that could increase food costs and create confusion among consumers.  Confectioners are faced with a lack of federal expertise and authority needed to dispel myths and confusion, and correct misinformation about the food ingredients and additives.  NCA says “it’s time for the FDA to get off the sidelines and clear up this misinformation because California is out of its depth regarding national food safety standards and regulatory processes. That expertise and authority rests with the FDA alone.”  According to an FDA spokesperson, the FDA is reviewing a petition from consumer advocacy groups to halt the use of red No. 3 in foods and will assess whether there is “sufficient data” to revoke its use.  More information can be found here and here.

Raw Milk Leads to Bacteria Outbreak in Wyoming and Utah
October 12:  In September, one adult and four children became ill after drinking raw, unpasteurized milk in Wyoming.  The patients were infected with campylobacter and E. Coli bacteria.  State investigators traced the Wyoming illnesses to consuming raw milk or raw milk products but did not identify the specific seller.  Meanwhile, public health official in Salt Lake County, Utah, are investigating an outbreak associated with raw, unpasteurized milk.  The Salt Lake County Health Department confirmed 14 people with infections from campylobacter and all but two of the patients reported drinking raw milk before becoming sick.  The source of the Utah raw milk has not been determined.

This Regulatory Update covers information from October 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including information collection activities for food and color additives, the new FSIS recall API data tool, and more.

FDA Updates

FDA Issues Advisory for Listeria Outbreak in Ice Cream
September 1:  As previously discussed, FDA is investigating an outbreak of Listeria monocytogenes infection linked to Soft Serve On the Go ice cream cups produced by Real Kosher Ice Cream of Brooklyn, NY.  Real Kosher Ice Cream and Ice Cream House of Brooklyn, NY, has voluntarily recalled all dairy and non-dairy products bearing the Ice Cream House logo that were manufactured in the Brooklyn, NY, facility.  FDA is advising consumers, restaurants and retailers not to eat, sell, or serve recalled Soft Serve on the Go cups and Ice Cream House products.  More information can be found here.

FDA Sponsors Workshops on the Use of Meta-Analysis in Nutrition Research and Policy
September 13:  FDA is sponsoring a series of three workshops to be hosted by the National Academies’ Food and Nutrition Board to discuss the usefulness of meta-analysis as a tool for nutrition research and developing nutrition policy.  The expert input and recommendations from the workshop will be helpful to FDA as it develops and implements evidence-based policies and regulations related to food labeling and labeling claims.  The workshops will be held on Tuesday, September 19; Monday, September 25; and Tuesday, October 3, 2023.  More information can be found here.

New FDA Animal and Veterinary Innovation Agenda Released
September 15:  FDA announced that it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products. The Animal and Veterinary Innovation Agenda released by FDA lists four objectives and details the supporting actions by the agency’s Center for Veterinary Medicine to foster product development and implement risk-based approaches to regulating modern animal and veterinary products. The new agenda applies to products like novel food ingredients that work solely in the animal’s gut to increase nutritional efficiency and production; animal biotechnology products such as animal cell- and tissue-based products and intentional genomic alterations in animals; and cell-cultured animal food ingredients.  More information can be found here.

FDA Information Collection Activities Announced for Food and Color Additives
September 21:  FDA announced a proposed collection of information for the submission of petitions concerning food additive and color additive, including labeling. Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food.  Written comments (including recommendations) on the collection of information are due by October 23, 2023.  More information can be found here.

FDA Amends Yogurt Company’s Temporary Marketing Permit
September 25:  FDA is amending Chobani, LLC’s temporary permit to market test lower-fat yogurt products. The temporary permit is amended to allow the use of the test product as an ingredient in other non-standardized food applications including beverages, dips, and sauces. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.  More information can be found here.

FDA Releases New Chapters to Draft Guidance Hazard Analysis and Risk-Based Preventative Controls for Human Food
September 27:  FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens.  The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods.   Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.  Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices.  Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations.

Comments on the draft guidance must be submitted by March 25, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here.

FDA Releases Video on Importing Safe and Compliant Food into the U.S.
September 29:  The FDA released a video titled “Importing FDA-Regulated Products: Human Foods” that provides basic information for importers, foreign suppliers/exporters, and customs brokers on the steps they need to take to successfully import safe and compliant food into the U.S.

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FDA Warning Letters

Unapproved New Drugs: FDA issued a warning letter to a Colorado company alleging that its Osmosis skin elixir products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Baby Food: FDA inspected a ready-to-eat baby food product manufacturing facility in California following a consumer complaint involving infant botulism. During the inspection, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule) and issued a warning letter to the company.

A database of warning letters can be found here.

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USDA Updates

FSIS Launches New Recall and Public Health Alert API Data Tool
September 12:  FSIS launched a new feature on its website that enables software developers to access data on recalls and public health alerts through an application programming interface (API) increasing the transparency and availability of critical public health information.  More information about the FSIS recall API can be found here.

FSIS Implements Modernized Chemical Residue Quantitative Method
September 15: The USDA Food Safety and Inspection Service (FSIS) developed an innovative method for beef muscle samples that uses modern chemistry instrumentation for quantifying chemical residues.  The new quantitative method for veterinary drug residue analysis in bovine muscle samples, entitled “Quantitation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS)” (CLG-MRQ1), will be implemented on October 1, 2023 and include the ability to:

• Quantitate multiple veterinary drug residue amounts simultaneously in a single analysis with high mass accuracy.
• Quantitate several veterinary drugs that were previously difficult to measure.
• Archive several single analyte or specific drug class quantitation methods that use older technology.
• Archive traditional residue bioassay for several analytes.
• Align detection limits with established drug residue tolerances.
• Decrease time to result for presumptive positive residues.

FSIS also updated three methods to the new Chemical Laboratory Guidebook format: Quantitation of Salt (CLG-SLT); Quantitation of Fat (CLG-FAT); and Screening, Quantitation, and Confirmation of Beta-Agonists by UHPLC-MS-MS (CLG-AGON1). These new and updated methods can be found on the Chemical Laboratory Guidebook page of the FSIS website.

FSIS Revised Directive – Food Defense Tasks and Threat Notification Response Procedures for the Office of Field Operations
September 26:  FSIS issued a revised directive that provides instructions to conduct food defense activities assigned to inspection program personnel at meat and poultry establishments, Siluriformes fish and fish product establishments, egg product plants, and import inspection establishments. Food defense activities include performing food defense tasks and observing and reporting food defense vulnerabilities. This directive also outlines the internal FSIS communication protocol for addressing threats to the food and agriculture sector.  More information can be found here.

FSIS Microbiological Sampling of Egg Substitutes, Freeze-Dried, and Agglomerated Egg Products
September 29:  FSIS issued a notice that provides instructions to inspection program personnel for the sampling of egg substitutes, freeze-dried, and agglomerated egg products. Egg substitutes, freeze-dried, and agglomerated egg products will be eligible for sampling under the current routine sampling programs starting on November 1, 2023.  More information can be found here.

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Other Articles of Interest

Exploratory Sampling Finds PFAS Presence in U.S. Food is Limited
September 12:  Government studies show that most U.S. food does not have excessive levels of per- and polyfluoroalkyl substances (PFAS) beyond food raised in certain contaminated areas.  The USDA FSIS has tested for PFAS in meat, poultry and catfish since 2020.  Out of 3,199 meat and poultry samples, less than 0.1% (2 bovine) had PFAS. Out of 616 catfish samples, 83 samples were positive for PFAS.  FDA’s tests on food have rarely detected high levels of PFAS, except within certain seafood.  More information concerning the FDA’s testing of PFAS in food can be found here.  More information concerning FSIS FY 2021 and FY 2022 Exploratory PFAS Sampling Data can be found here.

Judge Pares Back Class Action Lawsuit over Heavy Metals in Hershey Chocolate
September 12:  A federal judge for the US District Court for the Southern District of California scaled back a putative class action against The Hershey Co. saying the plaintiff did not show lead or cadmium levels in the company’s chocolate products “create an unreasonable safety hazard”, but the judge allowed the plaintiff claims seeking an injunction for Hershey to disclose the presence of the heavy metals.  The judge said the plaintiff’s suit failed to plead a duty to disclose, so the court granted Hershey’s motion to dismiss claims related to the alleged omission under California’s Consumer Legal Remedies Act. The court also concluded that the plaintiff failed to raise a viable claim for breach of implied warranty.  More information can be found here.

California Senate Passes Bill to Ban Certain Food Ingredients
September 13: The California Food Safety Act (AB418), which was passed by the State Assembly on May 15th, was passed by the State Senate.  AB418 seeks to ban harmful food additives already prohibited in the European Union.  The State Assembly version of AB418 bans Brominated vegetable oil, Potassium bromate, Propylparaben, titanium dioxide, and Red dye No. 3 from food. The State Senate bill took titanium dioxide off the banned list.  The fine for a first-time violation of the new law is $5,000, with each subsequent violation going to $10,000.  If the State Assembly concurs with the State Senate bill, the bill will then go to the Governor for signature.  More information can be found here.

Food Recalls Triggered by Foreign Objects More Common
September 17:  Foreign objects in food is one of the top reasons for food recalls in the U.S.  Food contaminated with foreign objects, such as metal, plastic, glass, or other “extraneous materials”, are common.  The FDA acknowledged that some contamination may even be expected.  In 2022, foreign objects triggered 9 recalls of more than 477,000 pounds of food regulated by the USDA FSIS.  In 2019, USDA reported 34 recalls of over 16 million pounds of food, including a recall of nearly 12 million pounds of Tyson chicken strips tainted with pieces of metal.  Detection of unwanted objects in food has improved over the years but some things are still missed.  Companies are asked to promptly notify USDA and FDA when food is potentially contaminated with objects that may harm consumers. The agencies then determine whether recalls are necessary.  Most recalls are voluntary.  Recently, companies have become increasingly cautious and are recalling products more frequently than before.  More information can be found here.  

New FDA Administrator Gets to Work
September 26:  On his first day as the FDA’s Deputy Commission for Human Foods, Jim Jones sent a letter to colleagues outlining his vision for transforming the agency into a single program that embraces coordination, prevention, and response activities.  He will be seeking ways to work more effectively with stakeholders to accomplish shared goals for a safer and more nutritious food supply.  More information can be found here.

Country Crock Class Suit Advances
September 27:  A proposed class suit was filed against Upfield US Inc.’s “Country Crock Plant Butter with Almond Oil” spread alleging that the label overstates the amount of almond oil in the plant-based spread.  The plaintiff alleged she was persuaded to by the product based on the almond oil representation and pictures of almonds on the container.  A judge for the U.S. District Court for the Southern District of New York allowed the action to proceed saying the words and images on the front of the container tell a reasonable consumer that the plant butter is made of almond oil. The judge dismissed the plaintiff’s breach of warranty, common-law fraud, and unjust enrichment claims.

Ancient Brands Avoids False-Ad Lawsuit Over Bone Broth Protein
September 27:  A judge for the U.S. District Court for the Northern District of New York said that bone broth consumers can’t sue Ancient Brands LLC for allegedly overstating the protein content of the product because federal food labeling law preempts their claims.  The plaintiffs alleged that the bone broth powders’ front label says “20g Protein,” and the nutrition facts panel says there are 20 grams of protein per serving.  The court said the plaintiffs’ contention that Ancient Grains should have used the corrected protein calculation is beyond what is required by the FDCA, and therefore expressly preempted because the law bars state requirements that aren’t “identical” to federal ones.  The plaintiffs were given 60 days to file an amended complaint.  More information can be found here.

Crafted Brand Sued Over Cocktail Mixers “No Preservatives” Label
September 28:  A proposed class suit was filed against Crafted Brand Co. alleging it deceptively markets Mai Tai and Pina Colada cocktail mixers as having no preservatives in the U.S. District Court for Southern California.  The plaintiff alleges that Crafted’s labeling is false because the products contain citric acid which is a common preservative.  A copy of the complaint can be found here.

Wendy’s and McDonalds Avoid False Advertising Lawsuit
October 3:  Wendy’s International LLC and McDonald’s Corp avoided a lawsuit alleging their ads make burgers look bigger than they are.  Lead Plaintiff, Justin Chimienti, alleged in a proposed class lawsuit that the eateries exaggerate the size of the burger patties in their ads by using uncooked meat which shrinks by about 25% when cooked.  The U.S. District Court for the Eastern District of New York said the ads were not misleading.  In addition, Chimienti failed to show he was financially harmed by the fast-food ads.  More information can be found here.

This Regulatory Update covers information from September 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, and other articles of interest, including an ice cream listeria outbreak, questions surrounding lab-grown meat, cannabis plain packaging rules, and more.

FDA Updates

FDA To Hold Modernizing Food and Drug Administration Recalls Listening Session
August 4: FDA will be hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023. The listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization for FDA-regulated products. Registration is required. More information can be found here.

FDA Revokes Uses of Partially Hydrogenated Oils in Foods
August 8: FDA is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). The direct final rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna, revises the regulations affirming the use of menhaden oil and rapeseed oil as GRAS to no longer include partially hydrogenated forms of these oils, and revokes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. FDA is also revoking prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on their conclusion that these uses of PHOs may be injurious to health. This rule will be effective December 22, 2023.

The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments. However, the agency is also issuing a companion proposed rule in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place. Comments on the direct final rule or its companion proposed rule must be submitted by October 23, 2023. More information and instructions for submitting comments can be found here.

FDA Investigates Ice Cream Listeria Outbreak
August 9: FDA is investigating an outbreak of Listeria monocytogenes infections linked to Soft Serve On The Go cups produced by Real Kosher Ice Cream of Brooklyn, NY. More information can be found here.

FDA’s Dietary Supplements Program Remains a Critical Priority
August 15: FDA published “Catching up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority,” by Robert M. Califf M.D., Commissioner of Food & Drugs. Under the new proposed Human Foods Program structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act. The new OFCSDSI is expected to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements. More information can be found here.

FDA to Hold Virtual Public Meeting and Listening Sessions on Strategies to Reduce Added Sugars Consumption in the U.S.
August 16: The FDA, in collaboration with other federal partners, will host a virtual public meeting followed by virtual public listening sessions to discuss strategies for reducing added sugars consumption in the United States. A virtual public meeting will be held on November 6, 2023, and virtual listening sessions will be held on November 7 & 8, 2023. More information, including meeting specifics and how to register for the virtual meeting and listening sessions, will be made available in September 2023 on the meeting page.

FDA Seeks Input on Citizen Petition to Amend Standard of Identity for Pasteurized Orange Juice
August 16: FDA announced that the Florida Citrus Processors Association (FCPA) and Florida Citrus Mutual (FCM) filed a citizen petition requesting that FDA amend the standard of identity (SOI) for pasteurized orange juice (POJ) by adjusting the minimum soluble solids content from 10.5° to 10° Brix. The agency is requesting comments, data, and information about the issues presented in the petition. Written comments and scientific data and information must be submitted by October 16, 2023. More information, including a link for submitting comments, can be found here.

FDA Commissioner Names EPA Veteran as Deputy Commission for Human Foods
August 24: James Jones was named Deputy Commissioner for Human Foods. He replaces former Deputy Commissioner for Food Policy Frank Yiannas and Susan Mayne, who headed the Office of Food Safety and Applied Nutrition. Jones is expected to begin at the FDA on September 24, 2023. While at the EPA, Jones oversaw efforts including a reduction in the impact of chemicals and pollution on the U.S. food supply. He also played a key role in the 2016 overhaul of the Toxic Substances Control Act that aimed to make it easier for the agency to regulate such compounds.

FDA Issues Proposed Rule to Amend Canned Tuna Standards
August 25: FDA is proposing to amend the standard of identity and standard of fill of container for canned tuna. This action partially responds to a citizen petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (dba Chicken of the Sea International). If finalized, the proposed rule would:

• Revise the weighing methods used to determine the standard fill of container;
• Allow the use of safe and suitable flavorings and spices as optional ingredients; and
• Clarify that the use of a packing medium is optional.

Written comments on the proposed rule must be submitted by November 24, 2023. More information, including a link for submitting comments, can be found here.

IFSAC Releases 2024-2028 Priorities
August 25: The Interagency Food Safety Analytics Collaboration (IFSAC)—a collaboration between the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the USDA Food Safety and Inspection Service (FSIS)—has published its upcoming priorities for calendar years 2024-2028. The following four priorities will guide the IFSAC’s work for the next five years:

• Improve foodborne illness source attribution estimates for Campylobacter;
• Develop foodborne illness source attribution estimates for non-O157 Shiga toxin-producing Escherichia coli (STEC);
• Finalize existing analyses; and
• Refine foodborne illness source attribution estimates using data from non-foodborne sources of pathogens.

For more information can be found here.

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FDA Warning Letters

Imported Food: FDA issued 4 warning letters to importers for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported food and produce.

Infant Formula: FDA issued warning letters to 3 companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated infant formula.

Imported Seafood: FDA issued warning letters to 2 companies for violations of CGMP regulations and seafood Hazard Analysis and Critical Control Point (HACCP) regulations related to adulterated seafood prepared under insanitary conditions.

Dietary Supplements: FDA issued warning letters to 2 companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements. 

A database of warning letters can be found here.

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USDA Updates

FSIS Extends Comment Period on Proposed Determination for Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products
August 2: On April 28, 2023, the USDA Food Safety and Inspection Service (FSIS) published a proposed determination titled Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products. FSIS is proposing to declare that not-ready-to-eat breaded stuffed chicken products that contain Salmonella at levels of 1 colony forming unit per gram or higher are adulterated within the meaning of the Poultry Products Inspection Act. FSIS extended the comment period for the proposed determination until August 11, 2023. More information, including a link for providing comments, can be found here.

FSIS Rescinds Regulations related to Condemnation of Poultry Carcasses affected with Avian Leukosis Complex
August 17: FSIS issued a final rule amending the poultry products inspection regulations to rescind several regulations related to the inspection and condemnation of poultry carcasses affected with any of the forms of avian leukosis complex. The final rule is effective September 18, 2023. On March 14, 2022, FSIS proposed to amend these regulations in response to a petition from the National Chicken Council which requested that the regulations be amended to designate avian leukosis as a trimmable condition rather than a condition that requires condemnation of the entire carcass. Under this final rule, carcasses affected with avian leukosis will be subject to the amended 9 CFR 381.87, which provides that any organ or other carcass part affected with tumors may be trimmed and that the unaffected parts of the carcass may be inspected and passed. More information can be found here.

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Other Articles of Interest

GOP Lawmaker Criticizes FDA for Inaction on Regulating CBD
July 27: Rep. Lisa McClain, R-Mich., chair of the House Oversight Subcommittee on Health Care and Financial Services, criticized the FDA for claiming it needs further congressional action to build a regulatory pathway for CBD products and discussed curtailing the agency’s funding.  According to Rep. McClain, the pathway already exists. While the agency earlier this year said it would not regulate CBD under its existing authority, it promised to work with Congress to develop a new regulatory pathway to oversee the products. More information can be found here.

Regulatory Questions emerge as Lab-Grown Meat Hits the Market
July 31:  Earlier this summer, the U.S. became the second country in the world, after Singapore, to approve the sale of cell-cultured or lab-grown meat. As lab-grown meat hits the U.S. market, the USDA and FDA face questions about how to label it. More information can be found here.

Organic Pastures Dairy Co., LLC Enters into Consent Decree
August 1: On July 27, 2023, the U.S. District Court for the Eastern District of California entered a consent decree in United States v. Organic Pastures Dairy Co., LLC, et al., Case No. 08-cv-1786 (E.D. Cal.). Organic Pastures Dairy Co., LLC (“Organic Pastures”) is a California-based company that manufactures and sells raw milk, raw milk products, and raw cheese and is subject to a 2010 injunction. The FDA moved for contempt in March 2023, alleging that Organic Pastures: (1) distributed an unapproved new drug in interstate commerce – its raw cheddar cheese for the prevention of diseases such as heart disease, osteoporosis, and viral infections and (2) failed to affix required statements on its invoices, packaging slips and websites. In May 2023, the Court issued an order finding that Organic Pastures, its founder, and its president had violated the 2010 injunction. The Court scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree providing the FDA with additional oversight, enforcement, and inspection authority and imposes regular auditing requirements on Organic Pastures.

EU Food Name Rules Curdle U.S. Cheese Producer
August 8: According to a Wall Street Journal article, the European Union expanded its list of foods, wines and spirits whose names are reserved for use by traditional local producers to more than 3,500 protected items. In Europe, feta cheese must be made in Greece. Gorgonzola cheese must be from Italy. U.S. food producers have also taken steps to protect products with geographical ties, such as Idaho potatoes, Florida oranges, and Hawaiian Kona coffee. The Consortium for Common Foods Names is pushing Congress to include a provision in the upcoming Farm Bill that would secure US food producers’ rights to use common food terms. Wisconsin Senator Tammy Baldwin is backing the bill along with Senate GOP Whip John Thune.

Campbell’s V8 Juice Health Deception Suit Advances
August 8: A class action suit advanced against Campbell Soup Co. alleges that the marketing of V8 Fruit and Vegetable Blends drinks are misleading because they portray the drinks as healthful substitutes for whole fruit and vegetables. The plaintiffs claim that the V8 Juice labels are deceptive because while fruit and vegetables can protect against disease, consuming juices increases the risk of disease. 

‘All Smoke and No Fire’ – Smokehouse Almond Deception Suit Dismissed
August 8: Blue Diamond Growers won dismissal of a consumer deception case involving its Smokehouse Almonds. Three similar Smokehouse cases have been dismissed. In this latest case, a Wisconsin man alleged that he overpaid for almonds because the almonds were not made in a smokehouse but that seasoned with liquid smoke flavoring. A Wisconsin federal judge said that the plaintiff lacked standing to pursue claims for money damages because he didn’t pay a price premium. Evidence showed that Blue Diamond Growers charged the same price for Smokehouse Almonds as other varieties. The judge also ruled that the plaintiff lacked standing to seek injunctive relief.

Frozen Meat Products Recalled Due to Lack of Federal Inspection
August 10: A Paterson, NJ meat packing company, is recalling 58,721 pounds of frozen, raw halal beef tripe, beef feet, and lamb tripe products that were produced without a federal inspection, according to the FSIS. The products were produced from January 2023 through August 2023. The problem was discovered during FSIS surveillance activities. More information can be found here.

Walmart Fish Oil Supplement Buyer Can Proceed with False-Ad Suit
August 11: Walmart Inc. lost its bid to dismiss a proposed class suit alleging its “Spring Valley 1000 mg Fish Oil” dietary supplement is deceptively called fish oil. The proposed class suit alleges that the Walmart fish oil supplement is a “lab synthesized solution” in which a chemical process is used to “molecularly alter and substantially transform otherwise unmarketable fish waste into a consumable product.” According to a federal judge in California, federal labeling law does not block allegations that consumers could be misled by the fish oil label. The judge declined to dismiss claims under California consumer protection laws as well as breach of warranty claims. More information can be found here.

Kellogg and Kashi Prevail in Cereal, Burger Protein-Label Appeals
August 14: Kellogg Co. and its Kashi Co. unit defeated appeals in separate proposed class suits by consumers alleging they were misled about the protein in breakfast cereals and Morningstar veggie burgers. The US Court of Appeals for the Ninth Circuit affirmed in a combined appeal that federal food labeling regulations preempt the state-law consumer protection suits. More information can be found here.

Ice Cream Company Sued After Listeria Recall
August 15: A proposed class action was filed in New York federal district court alleging that Real Kosher Ice Cream Inc. mislead consumers by not telling them about the risk of Listeria and cost them the money they spent on the frozen food. The proposed class action follows Real Kosher Ice Cream’s recall of soft-serve desserts. The Real Kosher Ice Cream Inc. said in its recall that the “on-the-go” ice cream and sorbet cups have the potential to be contaminated with Listeria monocytogenes, noting that there had been two reports of illnesses, one each in Pennsylvania and New York. (See related FDA Update above.)

Cannabis Plain Packaging Rules
August 15: There has been a lot of attention recently on hemp-derived products marketed in packaging that mimics popular snack foods. According to the FDA and various state regulators, this type of packaging has contributed to an increase in accidental consumption of intoxicating hemp products by minors. Concerns around hemp product packaging have arisen because there is little federal and state guidance as to packaging, labeling and content. All states have some level of prohibition on packaging that is attractive to minors, but states such as Massachusetts, Connecticut, New Jersey and Missouri prohibit packaging that mimics popular candy or food, limit the use of colors and impose other restrictions. More information can be found here.

Capri Sun Customer Voluntarily Drops Kraft Heinz PFAS Suit
August 24: A proposed class suit alleging Kraft Heinz Co.’s Capri Sun juice drinks are marketed as “healthy” and “all natural” when they contain undisclosed PFAS has been voluntarily dismissed. The plaintiff sued the company in U.S. District Court for the Northern District of Illinois alleging that independent testing detected PFAS substances in Capri Sun beverages but later dropped the lawsuit.

This Regulatory Update covers information from August 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, FDA warning letters, and other articles of interest, including a bill banning chemicals in food, warnings for Delta-8 THC products, PFAS found in juice, and more.

FDA Updates

FDA Provides Update on Proposed Changes to the Human Foods Program
June 27: FDA is proposing to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). Earlier this year, the FDA Commissioner announced a restructuring of the HFP. FDA is proposing additional changes that include establishing ORA’s core mission as conducting investigations, inspections, and laboratory testing for all FDA-regulated products, merging compliance functions currently managed within ORA into the HFP, realigning eight Human and Animal Food laboratories that are currently managed by ORA into the HFP, unifying state and local food safety partnership functions, and realignment of certain resources and personnel. More information can be found here.

Bill Banning Chemicals in Food Advances in California
June 30: The California Senate Committee on Health approved a bill (AB 418) to ban five chemicals from candy, cereals, and other processed foods. The bill, which is the first of its kind in the nation, prohibits the use of food products containing brominated vegetable oil, potassium bromate, propylparaben, red dye 3, and titanium dioxide, beginning on January 1, 2025. As discussed in our April 2023 update, several groups and trade associates oppose the bill. More information can be found here.

Companies Warned for Illegally Selling Delta-8 THC Copycat Snacks
July 5: The FDA and Federal Trade Commission (FTC) warned six companies to stop selling Delta-8 edibles that look like name-brand snacks such as Doritos, Oreos, Cheetos, Jolly Rancher, and Nerds. The warning letters were issued to the companies for illegally selling copycat food products containing Delta-8 tetrahydrocannabinol, also known as Delta-8 THC. According to the agencies, these products can easily be mistaken for traditional foods like chips, cookies, candy, gummies, or other snack food items. FDA is concerned that these products can be accidentally ingested by consumers, including children, or taken in higher doses than intended. More information can be found here.

FDA Releases Update of Priority Guidance Topics for Foods Program
July 6: FDA and the Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. The list updates the guidance agenda released in February 2023 and focuses on Level 1 draft and final guidance. A list of final guidance topics, as well as links to guidance documents released since February 2023, can be found here.

FDA Update on Post-Market Assessment of Certain Food Ingredients
July 12: FDA released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review. More information, including the public inventory database and list of chemicals, can be found here.

FDA Disagrees with WHO Report about Possibly Carcinogenic Sweetener
July 13: A report released by the World Health Organization determined the sweetener aspartame may “possibly” cause cancer. This new classification is based on a review of limited evidence and does not change the recommended limit on the daily intake of artificial sweetener. The FDA has disagreed with the new classification. More information can be found here.

FDA Reissues Two Temporary COVID-19 Guidances
July 13: FDA re-issued two temporary guidance documents originally published during the COVID-19 public health emergency for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). The two guidances extend the enforcement discretion policies issued during the public health emergency relative to supplier onsite audits for the FSMA Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs rule, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program, when certain circumstances are met. More information can be found here.

Findings from Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards Alignment
July 17: FDA announced the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act – 1) the Preventive Controls for Human Food and 2) the Produce Safety rules. More information can be found here.

FDA Denies Citizen Petition on Phthalates in Food Packaging and Food Contact Applications
July 24: FDA denied a petition requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022. The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns. FDA concluded that the reconsideration petition does not provide a basis for modifying the FDA’s response to the original citizen petition. More information can be found here.

Food Safety Modernization Act 2024 User Fees Announced
July 28: FDA announced fiscal year 2024 user fee rates for the Third-Party Certification Program, the Voluntary Qualified Importer Program, and for domestic and foreign facility reinspections. For recognized accreditation bodies and accredited certification bodies, as well as the initial and renewal fee rate for accreditation bodies applying to be recognized in the Third-Party Certification Program, the fee is effective on October 1, 2023 and will remain in effect through September 30, 2024. The 2024 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program is effective August 1, 2023 and will remain in effect through September 30, 2024. The 2024 fee rate for domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections are effective October 1, 2023 through September 30, 2024. More information about the Third-Party Certification Program 2024 user fee rates can be found here. More information about the Voluntary Qualified Importer Program 2024 user fee rates can be found here. More information about the 2024 domestic and foreign facility reinspection fee rates can be found here.

FDA Publishes an Update on Sesame Allergen Labeling
July 28: FDA published “Catching Up with Califf: An Update on Sesame Allergen Labeling on Food Packages,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. Sesame was added as the ninth major food allergen earlier this year when the Food Allergy Safety, Treatment, Education, and Research Act went into effect. Sesame is now required to be listed on food labels as a major allergen. The update provides information on the work underway to help sesame-allergic consumers find safe food options.

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FDA Warning Letters

Imported Food: FDA issued 6 warning letters to importers for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported food and produce. FDA also issued a warning letter to a California importer for FSVP violations in response to a recent recall event associated with enoki mushroom products imported from a foreign supplier that tested positive for Listeria monocytogenes.

Unapproved New Drugs: A warning letter was issued to a Missouri entity selling bee propolis and other products alleging the use of marketing claims that render the products as unapproved new drugs.

Delta-8 THC Products: FDA issued warning letters to 7 companies selling Delta-8 THC products (such as gummies, sour worms, Stoneo Oreo Cookies, Hot Cheetos, Delta 8 Rope Candy, Pot Tarts, Trips Ahoy medicated chocolate cookies, Delta 8 Nerds Candy, Dope Rope Bites, D8 chocolate bars, THC infused nacho chips, etc.) that are adulterated because they contain an unsafe food additive and may pose a serious health risk to consumers. FDA is also concerned that Delta-8 THC copycat foods may be attractive to children and mistaken for traditional foods.

Dietary Supplements: FDA issued warning letters to two companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements. FDA alleged that the supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

A database of warning letters can be found here.

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Other Articles of Interest

Coca-Cola Sued over PFAS-laden Simply Tropical Juice
July 17: A consumer class action lawsuit filed in U.S. District Court of the Southern District of New York alleges that Coca-Cola Company falsely advertises its “Simply Tropical” juice products as all natural, while failing to disclose that they contain high levels of per- and poly-fluoroalkyl substances known as PFAS. The complaint accuses Coca-Cola and its subsidiary the Simply Orange Juice Co. of breach of warranty, violating the Magnuson-Moss Warranty Act, breaking federal and New York deceptive trade practices, negligence and unjust enrichment. More information can be found here.

Dole Sued over Sugar in Fruit Products Marketed as Healthful
July 5: A class action suit was filed against Dole Packaged Foods LLC in the U.S. District Court for the Northern District of California alleging that it deceptively represents various fruit products as healthy, nutritious, and beneficial to the immune system despite a high sugar content that increases the risk of various illnesses. The complaint asserts that Dole markets fruit bowl snacks to children even though the snacks have 166 percent more added sugar than the American Heart Association’s recommended daily limit. More information can be found here.

USDA and Bipartisan State Attorneys General Launch Agricultural Competition Partnership to Help Reduce Anticompetitive Barriers Across Food and Agriculture Supply Chains
July 19: USDA launched a partnership with bipartisan attorneys general in 31 states and the District of Columbia to enhance competition and protect consumers in food and agricultural markets, including in grocery, meat and poultry processing. More information can be found here.

Demand for Meat in China Could Lead to Much Larger Imports
July 31: According to a recent USDA report, meat consumption in China has increased significantly since the 1970s. USDA economists said per capita meat consumption in China could increase 40% by 2031. The USDA report said: “This trend creates new opportunities for exporters in the United States and other countries, but it also poses food security challenges and environmental impacts.” A copy of the USDA report can be found here.

Lawmakers Push FDA to Regulate Cannabidiol as Dietary Supplement
July 27: Lawmakers and hemp advocates urged the FDA to regulate cannabidiol products as dietary supplements during a hearing before the House Oversight Subcommittee on Health Care and Financial Services. Advocates say consumer safeguards in the Federal Food, Drug and Cosmetic Act would apply to CBD products if regulated as dietary supplements, including good manufacturing standards, adverse event reporting, strict labeling with warnings, and potential child-proof packaging. Meanwhile, congressional leaders in both chambers are seeking public input and announced a bicameral Request for Information about FDA regulation of CBD products. More information can be found here.

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This Regulatory Update covers information from July 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, USDA updates, and FDA warning letters, including guidance for inorganic arsenic in apple juice, a proposed rule for front-of-package nutrition labels in the U.S, and more.

FDA Updates

Final Guidance for Inorganic Arsenic in Apple Juice Now Available
June 1: FDA announced the availability of a final guidance for industry titled “Action Level for Inorganic Arsenic in Apple Juice.” The final guidance identifies the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice that was issued in draft by the agency in 2013. The final guidance comes after Consumer Reports tested 21 popular fruit juices and found elevated levels of cadmium, inorganic arsenic, and/or lead in 2018. FDA expects that the 10-ppb action level, though non-binding, will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency will continue its current practice of monitoring arsenic in apple juice samples, and if testing identifies inorganic arsenic in apple juice above 10 ppb, FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action. A copy of the final guidance can be found here.

FDA Launched Webpage on Equivalence and Food Safety
June 5: The FDA has published a new webpage dedicated to equivalence for food safety. Equivalence is the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection measures required by U.S. law. The webpage explains how equivalence is determined, current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products. The Equivalence and Food Safety webpage can be found here.

Comment Period Extended for Color Additive Petition
June 28: FDA is extending the comment period for a color additive petition submitted by Environmental Defense Fund, notice of which was published in the Federal Register on May 3, 2023. The petition requests that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods. The deadline to submit comments has been extended to September 1, 2023. More information and a link for submitting comments can be found here.

Comment Period Extended for Dietary Guidance Statements in Food Labeling
June 15: The FDA is extending the comment period for the draft guidance titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry,” that was published on March 27, 2023. The deadline to submit comments has been extended to September 25, 2023. More information can be found here.

New FSMA Food Traceability Rule FAQs Available
June 26: The FDA published new frequently asked questions (FAQs) and additional tools to provide industry with more information about FDA’s Food Safety Modernization Act (FSMA) Food Traceability Rule. The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. The FAQs regarding the Food Traceability Rule can be found here and more information can be found here.

Final Guidance for Quantitative Efficacy and Risk Information in DTC Advertisements
June 27: The FDA issued a final guidance for industry entitled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The purpose of the guidance is to provide industry with recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs, as well as DTC promotional labeling for over-the-counter animal drugs. A copy of the final guidance can be found here.

FDA Testing Front of Food Package Nutrition Labels
June 14: The FDA is considering a proposed rule for front-of-package nutrition labels in the U.S.  This proposed rule would require the front of food labels to display certain nutrition information to make it easier for consumers to make more informed dietary choices, which are intended to complement the nutrition facts label on packaged foods. FDA hopes to release a proposed rule on these labels by December 2023. More information can be found here.

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FDA Warning Letters

Ready-to-eat Mandarin Oranges: A Chinese ready-to-eat (RTE) mandarin orange food manufacturing facility was issued a warning letter after FDA investigators found a serious violation of the Current Good Manufacturing Practices & Preventive Controls for Human Food Rule (“CGMP/PC Rule”). FDA determined that RTE mandarin oranges in light syrup in glass jars manufactured in the facility were adulterated because they were prepared, packed, or held under insanitary conditions.

Chewable Calcium with Vitamin D for Kids: A pharmaceutical company selling “Chewable Calcium 600 mg with Vitamin D for Kids in Orange Flavor” was issued a warning letter by FDA for misbranding of the product and selling the product, which FDA considers an unapproved new drug.

Ready to Eat Bread Rolls: FDA issued a warning letter to a RTE bread roll facility in Ohio for serious violations of the CGMP/PC Rule. FDA investigators determined the RTE buns processed at the facility are adulterated in that they were prepared, packed, or held under insanitary conditions.

A database of warning letters can be found here.

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USDA Updates

New Guideline for Salmonella Control in Swine Slaughter and Pork Processing
June 1: The USDA Food Safety and Inspection Service (FSIS) updated its guideline for pork producers on controlling Salmonella in swine from pre-harvest through slaughter. The guideline covers pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage. It provides information on best practices that may be applied at slaughter facilities to prevent, eliminate, or reduce levels of Salmonella on swine at all stages of slaughter and dressing. It also contains best management practices for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.  A copy of the guideline can be found here.

Best Practices Guidance Available for Controlling Listeria in Delicatessens
June 20: FSIS released an updated guidance entitled “Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens.” The best-practices guidance discusses steps that retailers can take to prevent certain ready-to-eat foods that are prepared or sliced in retail delicatessens and consumed in the home from becoming contaminated with Listeria and thus a source of listeriosis. More information and a copy of the guidance can be found here.

FSIS Issues Updated Cell-Cultured Meat and Poultry Food Products Sampling Program
June 29: FSIS issued a notice of updates to the Cell-Cultured Meat and Poultry Food Products Sampling Program. The notice has been updated to reflect sampling of ready-to-eat products. The notice also provides instructions to inspection program personnel on how to collect cell-cultured meat and poultry food products and send samples to the FSIS Eastern Laboratory for microbiological, chemical residue, speciation testing, and pathology. More information can be found here.

Revised Directive for Responsibilities in Dual Jurisdiction Establishments
June 21: The directive for Responsibilities in Dual Jurisdiction Establishments provides instruction to FSIS inspection program personnel (IPP) about their roles and responsibilities regarding inspection, verification, documentation of findings, reporting and enforcement actions in establishments that operate under the jurisdiction of both FSIS and the FDA. FSIS revised this directive to reflect the updated Memorandum of Understanding between FSIS and FDA and to provide instructions to IPP in establishments that harvest cells for cell-cultured meat and poultry food products. More information can be found here.

USDA Considering Cracking Down on Animal-Raising Claims
June 14: USDA has launched a multi-step effort to strengthen standards used to substantiate animal-raising claims such as “raised without antibiotics,” “grass-fed,” and “free-range,” among others. This effort comes after petitions, comments, and letters requested USDA to reevaluate its oversight of how animal-raising claims are substantiated. To address concerns, FSIS, along with USDA’s Agricultural Research Service, will conduct a sampling project to assess antibiotic residues in cattle marketed with the “raised without antibiotics” claim. In addition, FSIS will be issuing a revised industry guideline to recommend companies strengthen the documentation they submit to substantiate animal-raising claims. More information can be found here.

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This Regulatory Update covers information for June 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.

This update includes FDA updates, USDA updates, and FDA warning letters, including a draft compliance guide for major food allergen labeling, the availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline, and more.

FDA Updates

Draft Compliance Guide Available for Major Food Allergen Labeling and Cross-contact
May 16: The FDA released a draft Compliance Policy Guide (CPG) entitled “Sec. 555.250 Major Food Allergen Labeling and Cross-contact” for public comment. The CPG, when finalized, will replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. The current CPG was written before the enactment of the Food Allergen Labeling and Consumer Protection Act (2004), FDA Food Safety Modernization Act (2011), and the Food Allergy Safety, Treatment, Education and Research Act (2021). The current CPG also does not reflect requirements in FDA’s regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

The draft CPG describes (1) the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations; (2) requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact; (3) describes additional allergen labeling violations; and (4) directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. Comments on the draft CPG are due July 17, 2023. A copy of the draft CPG can be found here along with a link for submitting comments.

FDA Releases Small Entity Compliance Guide on Requirements for Additional Traceability Records for Certain Foods
May 18: The FDA published a Small Entity Compliance Guide (SECG) entitled “Requirements for Additional Traceability Records for Certain Foods: What you need to know about the FDA Regulation” to help small entities comply with the final rule. The Food Safety Modernization Act Food Traceability Rule was issued in November 2022 and the compliance date for recordkeeping requirements is January 20, 2026. The SECG can be found here.  More information about the Food Traceability Rule can be found here.

FDA Receives Color Additive Petition Regarding Use of Titanium Dioxide in Food
May 3: Earlier this year, FDA received a color additive petition from Environmental Defense Fund, et al., asking the agency to revoke the color additive listing for the use of titanium dioxide in food. On May 3, FDA published notice of the filing in the Federal Register. The petitioners assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i). A copy of the petition can be found here. Comments on the petition are due by September 1, 2023 and may be submitted using the link here.

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FDA Warning Letters

In May 2023, the FDA posted nine warning letters, including the following notable letters:

FSVP: FDA issued three warning letters related to alleged violations of the Foreign Supplier Verification Program (FSVP). 

Produce Safety: A warning letter was issued to a Nebraska-based alfalfa sprouts producer for alleged violations of the Produce Safety Regulation (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

Unapproved New Drug: A warning letter was issued to an Oregon entity selling tea and herbal products alleging the use of marketing claims that render the products an unapproved new drug.

A database of warning letters can be found here.

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USDA Updates

Availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline
May 5: USDA’s Food Safety and Inspection Service (FSIS) announced the availability of a guidance document for manufacturing ready-to-eat (RTE), shelf-stable, fermented, salt-cured, and dried meat and poultry products that do not use cooking as the primary lethality step. The guideline addresses commonly asked questions concerning the food safety hazards associated with these products and the key steps in each process to ensure safety. This guideline replaces and expands upon information previously found in other guidance documents addressing the safe production of RTE fermented meat and poultry products. FSIS also published Instructions for Training associated with the guideline. The Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline can be downloaded here and Instructions for Training can be downloaded here.

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This Regulatory Update covers information for May 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.