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This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including the revocation of authorization to use brominated vegetable oil, a proposed new policy to reduce salmonella in raw poultry, findings from a fresh herbs study, and more.

FDA Updates

FDA Revokes Authorization for Use of Brominated Vegetable Oil in Food
July 3:  The Food and Drug Administration (FDA) is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food. BVO is a vegetable oil that is modified with bromine. The FDA concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health found the potential for adverse health effects in humans. The rule is effective August 2, 2024.  Companies have one year after the effective date to comply with the rule to reformulate, relabel, and deplete the inventory of BVO-containing products.  More information can be found here.

FDA Files Phytolon Ltd. Color Additive Petition
July 18:  The FDA has filed a petition, submitted by Phytolon Ltd., proposing to amend color additive regulations in 21 CFR part 73 to provide for the safe use of prickly pear yellow for the coloring of foods generally in amounts consistent with current good manufacturing practice.  More information can be found here.

FDA Collecting Information on Testing and Corrective Measures for Bottled Water
July 23:  The FDA is soliciting comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements. The respondents to this information collection are domestic and foreign bottled water manufacturers that sell bottled water in the U.S. Comments must be submitted by September 23, 2024.  More information can be found here.

FDA Collecting Information on Regulations Under the Federal Import Milk Act
July 23:  The FDA announced a collection of information pertaining to regulations under the Federal Import Milk Act.  The information collected will be used by FDA to determine whether a permit to import milk and/or cream into the United States should be granted.  Respondents include foreign dairy farms and plants engaged in transporting milk and/or cream into the United States. The comment deadline is August 22, 2024.  More information can be found here.

FDA Reopening Comment Period for Food Additive Petition
July 25:  The FDA is reopening the comment period for the notification of a food additive petition, published in the Federal Register on 4/26/2024, submitted by Environmental Defense Fund, et al.  The petition proposes that the food additive regulations be amended to remove fluorinated polyethylene. FDA is reopening the comment period to add the food additive petition to the docket and making a correction to the filing notice.  Comments must be submitted by September 23, 2024.  More information can be found here.

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FDA Warning Letters

Copycat Delta-8 THC Food Products: The FDA and Federal Trade Commission (FTC) issued warning letters to six companies for illegally selling food products containing Delta-8 THC that mimic chips, candies and snacks, and which are sold in deceptive packaging that could easily be confused for popular national brands.  The FDA and FTC are concerned that copycat food products containing Delta-8 THC are easy to purchase and often available to youth. The agencies are also concerned that the processes used to synthesize Delta-8 THC can result in edible products that may be harmful or have unpredictable effects on consumers. 

Low Acid Canned Food:  The FDA issued a warning letter to a Chinese manufacturer of low acid canned food for violating federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers, rendering the company’s 230g pouches of roasted gluten adulterated.

Adulterated Granola:  The FDA issued a warning letter to PepsiCo, Inc. following an inspection of its ready to eat (RTE) food manufacturing facility in Illinois that manufactures RTE granola bars and cereals.  The inspection was initiated in response to a Reportable Food Registry report and recall of the company’s granola bars and granola cereals announced on December 15, 2023.  The FDA determined that the RTE granola bars and cereals manufactured in the facility are adulterated and violate the Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation because they were prepared, packed, or held under insanitary conditions.

Misbranded Dietary Supplements:  The FDA issued a warning letter to Formulation Technology, Inc. involving its product (b)(4), which is intended to cure, treat, or prevent migraines.  According to the FDA, the (b)(4) product is not generally recognized as safe and effective for this use and is considered an unapproved new drug.  The FDA also alleged the product is an adulterated dietary supplement and misbranded because it does not comply with the labeling requirements for dietary supplements and because they 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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USDA Updates

FSIS Begins New Allergen Verification Sampling Program
July 19:  Beginning on September 1, 2024, the USDA Food Safety and Inspection Service (FSIS) will launch a new allergen verification sampling program targeting RTE products that declare the absence of specific food allergens on their labeling. This program will test for common allergens, including soy, various shellfish, eggs, peanuts, milk, various tree nuts, and gluten. FSIS intends to continue to develop the sampling program to include analysis for sesame. FSIS is implementing this program to expand its verification of industry compliance with labeling regulations. This new program expands upon and replaces FSIS’ current soy testing program to include multiple allergens and gluten, in addition to soy. The program aims to ensure the accuracy of labeling claims for allergens in RTE products, ultimately enhancing consumer safety. More information can be found here.

USDA Proposes New Policy to Reduce Salmonella in Raw Poultry Products
July 29: The FSIS issued a comprehensive proposed rule and determination to reduce Salmonella contamination and illnesses associated with raw poultry products.  The proposed rule would make it illegal to sell chicken, chicken parts or ground chicken and turkey if it is found to be contaminated with certain types of Salmonella. The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed rule would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.   Comments on the proposed rule must be received by October 7, 2024.  More information can be found here.

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Other Articles of Interest

USDA Proposes Amendments to Milk Pricing Amid Dairy Industry Concerns
July 10:  Following a lengthy hearing process, the USDA’s Agricultural Marketing Service (AMS) proposed amendments to federal milk marketing orders to update milk pricing formulas. The modifications could affect protein, solid content, and surveyed commodity prices, as well as factoring in changes to manufacturing allowances for several dairy products. Some stakeholders, including the American Farm Bureau and National Milk Producers Federation, are cautiously optimistic but express concerns over processing costs and the transparency of data informing these costs.  Key changes include raising the value returned to farmers for bottled milk and updating the pricing structures for cheese and butter products. However, proposed reductions in class prices to accommodate processing costs are disputed due to lack of solid data on those costs. The proposed amendments have been published in the Federal Register.  Stakeholders have until September 13, 2024 to submit comments. A final rule is expected to be published in mid-November.  More information can be found here and on the AMS website.

Petitions Filed with EPA Seek to Ban PFAS in Pesticides and Plastic Containers
July 23:  Citizen groups have petitioned the US EPA to revise regulations to prohibit per- and polyfluoroalkyl substances (PFAS) and plastic containers that leach PFAS chemicals into stored pesticides.  A coalition led by the Center for Food Safety petitioned the EPA to amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ban PFAS from pesticides.  The coalition is requesting the EPA adopt a broad regulatory definition of PFAS and prohibit pesticides from being stored or transported in fluorinated high-density polyethylene and polypropylene containers. Earlier in July, the EPA granted a separate petition from environmental groups urging the EPA to take action under the Toxic Substances Control Act (TSCA) to regulate PFAS created through fluorination.  In granting that petition, the EPA agreed to address PFAS created during the fluorination of plastic containers that are used in a variety of household and industrial products.

FDA Releases Findings from Fresh Herbs Study
July 26:  The FDA released findings from a sampling assignment that collected and tested domestic and imported fresh basil, cilantro, and parsley to estimate the prevalence of Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC) in the herbs.  From September 2017 to September 2021, the FDA tested a total of 1,383 samples of fresh basil, cilantro, and parsley.  Salmonella was detected in 17 out of 1,358 samples, C. cayetanensis was detected in 18 out of 812 samples, and STEC was detected in 1 out of 1,350 samples.  This data will help the FDA develop guidance and update program priorities.  More information can be found here.

FDA Announces Food Safety Modernization Act User Fee Rates for FY 2025
July 31:  The FDA announced the fiscal year (FY) 2025 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The FDA also announced FY 2025 fee rates for certain domestic and foreign facility reinspections, including failures to comply with a recall order and importer reinspections. The user fee rates are authorized by the FDA Food Safety Modernization Act and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs. The fees apply from October 1, 2024, through September 30, 2025. More information can be found here.

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Lawsuits

Nestle Seeks Dismissal of Poland Spring ‘Natural Spring Water’ Labeling Lawsuit
July 7:  Nestle Waters North America Inc., which owns the Poland Spring brand, is seeking to dismiss a lawsuit alleging the brand’s water does not come from an actual spring. The class action lawsuit alleges that the Poland Spring water is falsely labeled as “100% Natural Spring Water” when it is sourced from wells and boreholes, not natural springs. In a Connecticut federal court, Nestle argued that the term “spring water” means different things to different people and that there is no proof consumers were confused or deceived.  U.S. District Judge Jeffrey A. Meyer noted consumer preference for spring water but questioned the definition clarity of what defines spring water. The plaintiffs allege fraud and consumer protection violations, while Nestle contends that definitions and customer perceptions of spring water vary widely. The case, ongoing since 2017, awaits a decision on Nestle’s summary judgment motion with class certification on hold. Judge Meyer has committed to delivering a decision as soon as possible.

Albertsons Seeks Dismissal of ‘Naturally Flavored’ Cereal Bar Labeling Lawsuit
July 8:   Grocery store chain, Albertsons, urged a California federal judge to dismiss a class action lawsuit accusing it of falsely advertising its Signature Select cereal bars as “naturally flavored,” despite the use of artificial malic acid. The plaintiff, Mark Trammell, claims he was misled by the label and would prefer to consume foods with only natural flavors. Albertsons argues that similar cases have been dismissed nationwide as courts found such labels did not deceive reasonable consumers and did not claim the products were free from artificial ingredients. Albertsons maintains their labeling meets FDA requirements, the presence of malic acid is disclosed, and its use is for flavor balance, not as a characterizing flavor. The plaintiff’s standing to sue is also questioned, suggesting his claims are driven by motives for litigation rather than consumer deception.  A copy of Albertsons memorandum to the Court in support of its motion to dismiss can be found here.

Coca-Cola Faces Revised Class Action Suit over PFAS in Simply Orange Juice
July 11:   An amended proposed class action lawsuit was refiled against Coca-Cola and its Simply Orange Juice Co. subsidiary, claiming that they falsely advertise their juices as pure, healthy, and all-natural, despite allegedly containing PFAS compounds. The plaintiff’s prior complaint was dismissed in June 2024 because the test results were not sufficiently connected to his purchases of Simply Orange products.  The amended complaint cites new third-party testing, claiming uniform contamination in the product line, including excessive levels of PFAS in certain products, like Simply Tropical. The plaintiff alleges that testing revealed PFAS levels more than 100 times above health advisory levels for drinking water as issued by the EPA. He further contends that some products he had purchased, including pulp-free Simply Orange and Simply Orange with Mango, contained dangerous levels of PFAS compounds. According to the complaint, Coca-Cola has been aware of PFAS since at least 2021 but continued to market the Simply Orange products under the guise of being natural and using “pure filtered water,” without disclosing the presence of PFAS.  The plaintiff argues that this constitutes misbranding, as well as negligence and unjust enrichment, and it violates the New York Deceptive Trade Practices Act and New York State Agriculture and Markets Law.  A copy of the amended complaint can be found here.

Snapple Owner Wins Temporary Dismissal in ‘All Natural’ Labeling Class Action
July 17:   Keurig Dr Pepper Inc. has temporarily prevailed in a case where it was accused of falsely advertising its Snapple and Nantucket Nectars beverages as “all natural” while they allegedly contain PFAS chemicals. The lawsuit was dismissed by the Eastern District of New York because the lead plaintiff, Timothy Walker, did not provide sufficient details about his injury for standing purposes, such as the timing of his purchases or when he conducted the testing that allegedly detected PFAS. The lawsuit alleged consumers were misled by the “all natural” label and sought claims under New York’s General Business Law for breach of warranty, fraud, and unjust enrichment. However, the Court found the evidence presented, particularly around systematic contamination and PFAS levels, to be inadequate without more precise information. The dismissal was without prejudice, meaning Walker can file an amended complaint.

Eggland’s Best Faces Class Action over Alleged Deceptive ‘Cage Free’ Egg Labeling
July 24:   A proposed class action lawsuit was filed against Eggland’s Best Inc. in the US District Court for the Northern District of Illinois for falsely marketing some eggs as “cage free” when, as the lawsuit alleges, the eggs are produced by hens living in cramped, factory-farm conditions. The plaintiffs assert that the packaging is deceptive because it claims that hens are free to roam in natural environments.  They argue that consumers are misled to pay a premium for these eggs under the belief they are encouraging better animal welfare standards.  According to the complaint, the hens are kept in large, artificial structures that restrict natural behavior and outdoor access. The lawsuit is based on claims of consumer fraud and unjust enrichment under Illinois law. A copy of the complaint can be found here.

Environmental Groups Sue EPA over PFAS in Plastic Containers
July 25:   In addition to the petitions filed with US EPA described above, environmental groups also filed a lawsuit against the EPA in the US District Court for the District of Columbia alleging the lack of action to regulate the distribution of plastic containers contaminated with PFAS.  The environmental groups argue that the EPA violated the Toxic Substances Control Act (TSCA) by failing to act within 180 days of receiving information that suggests a significant risk of harm from PFAS and they ask EPA to halt the manufacture and distribution of “tens of millions” of containers.  The complaint alleges a harmful type of PFAS is created through the fluorination of plastic containers by Inhance Technologies LLC and the EPA is obligated to act under TSCA as the agency had conclusive data since March 2023 that PFAS is found in fluorinated plastic containers.  However, the EPA previously attempted to order a halt to Inhance’s production of PFAS in plastic containers only to be struck down in court.  A copy of the complaint can be found here.

This Regulatory Update covers information from July 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 and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including exemptions from food traceability requirements, regulating genetically edited meat, an update on avian flu in the raw milk industry, and more.

FDA Updates

Sufficient Lab Capacity Reached for Import-Related Food Testing under LAAF Program
June 3:  As described in our May 2024 update, the FDA determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import-related food testing for mycotoxins. Importers must use accredited labs for mycotoxin food testing starting December 1, 2024. As the program expands capacity for other analytes, they will be listed on the LAAF Dashboard with the compliance date set at six months from the date a specific analyte is posted on the Dashboard.  More information can be found here.

FDA Collecting Information on Record Retention Requirements for Soy Protein and Reduced Risk of Coronary Heart Disease Health Claim
June 6:  FDA announced a proposed collection of information pertaining to record retention requirements for the soy protein and reduced risk of coronary heart disease (CHD) claim. This information collection enables FDA to review food labeling ingredient information to determine the basis of soy protein/CHD health claims. Respondents are required to retain records for inspection regarding calculation of the ratio of soy protein to total protein in a food when that food bears a soy protein/CHD health claim.  Written comments are due July 8, 2024.  More information can be found here.

FDA Collecting Information on Irradiation in Production, Processing and Handling of Food
June 7:  FDA announced a proposed collection of information pertaining to irradiation in the production, processing, and handling of food.  Respondents to the information collection are businesses engaged in the irradiation of food.  Written comments must be submitted by July 8, 2024.  More information can be found here.

FDA Co-Sponsors Report on the Role of Seafood Consumption in Child Development
June 11:  The FDA commissioned a study to help provide the agency with the most recent information on seafood and child development.  The National Academies of Sciences, Engineering, and Medicine (NASEM) published a final report, The Role of Seafood in Child Growth and Development, that was co-sponsored by the FDA. The report concluded that there is not enough evidence to suggest a need to revise the amounts of seafood recommended in the Dietary Guidelines for Americans.  Furthermore, there is not enough evidence to assess the impact of exposure to contaminants from seafood other than mercury.  The report recommends that the FDA monitor the evidence as well as methodologies for integrating and assessing both risks and benefits from seafood on child developmental outcomes.  More information can be found here.

FDA Proposes to Exempt Grade “A” Cottage Cheese from Food Traceability Requirements
June 14:  The FDA issued a proposed exemption for certain cottage cheese products from the Food Traceability Rule requirements that are regulated under the Grade “A” Pasteurized Milk Ordinance. The proposed exemption would apply to all Grade “A” cottage cheese products that appear on the Interstate Milk Shippers List. The deadline for submitting written comments on the proposed exemption is September 16, 2024.  More information can be found here and the proposed rule can be found here.

FDA Official Expresses Frustration Over Persistent Kratom Market Despite Federal Stance
June 28:  The director of the FDA’s Office of Dietary Supplement Programs expressed frustration at the continued presence of kratom products in the U.S. market despite the FDA’s clear stance against them. The FDA reaffirmed its position that kratom is not lawfully marketed in the U.S. as a drug product, dietary supplement, or food additive in conventional food. Despite FDA efforts, kratom, a substance sourced from a Southeast Asian tree and used by millions in the U.S., remains available. The FDA considers kratom a new dietary ingredient (NDI) for which there is inadequate information to ensure it does not pose a significant or unreasonable risk of illness or injury.  The American Kratom Association disputes the FDA’s assertions, claiming safe use of kratom by over 15 million Americans and accusing the FDA of bias against dietary supplements. Eleven states have passed Kratom Consumer Protection Acts, contrary to the FDA’s position.  More information can be found here. 

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FDA Warning Letters

Bimbo Bakery Mislabeled Bakery Products: The FDA issued a warning to Bimbo Bakeries USA for mislabeling bakery products with allergens not included in the formulation. The warning letter was prompted by findings during two inspections at Phoenix and Topeka facilities in late 2023 where certain bakery products from Bimbo Bakeries included ingredients that are or contain major food allergens on their labels, but those ingredients were not actually present in the product formulations.  Several ready-to-eat (RTE) bread products incorrectly labeled allergens such as sesame, walnuts, almonds, and hazelnuts.  More information can be found here.

Adulterated Food:  The FDA issued a warning letter to Dollar Tree Inc. for the receipt and sale of adulterated WanaBana Apple Cinnamon Fruit Puree pouches. Since October 2023, the FDA has investigated high lead levels in WanaBana Apple Cinnamon Fruit Puree pouches that were linked to several cases of elevated blood lead levels in children. Lab tests confirmed extremely high concentrations of lead, leading to a voluntary recall by Wanabana USA. The FDA alleged that Dollar Tree stores continued to sell the recalled products which is a violation of the Federal Food, Drug, and Cosmetic Act. Although Dollar Tree took steps to address the issue, the FDA found these measures inadequate and continued finding the product on shelves through December, expressing concerns over Dollar Tree’s long-term corrective actions.

A database of warning letters can be found here.

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USDA Updates

USDA Proposes Measures to Improve Poultry Markets and Protect Growers
June 3:  The U.S. Department of Agriculture (USDA) has proposed new steps to create fairer markets for poultry growers and farmers. These actions seek to address competition issues, enhance transparency, and protect producers. The proposed rule Poultry Grower Payment Systems and Capital Improvement Systems  targets abuses related to payment systems and capital investment requirements for broiler chicken contract growers. USDA is also introducing publicly available cattle market transparency tools. These efforts align with President Biden’s commitment to promote competition in the American economy.  More information can be found here.

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Other Articles of Interest

FDA Takes Lead in Regulating Genetically Edited Meat
June 4:  The FDA announced that it will lead the regulatory process for bringing gene-edited meat to market. Gene editing, often referred to as CRISPR, allows researchers to modify specific genes in an animal’s genome, seeking to improve health, productivity, and nutritional benefits. Unlike genetic modification, which involves inserting foreign DNA, gene editing works within a species’ own DNA. Last year, the FDA authorized pork from gene-edited pigs for human consumption, emphasizing that the edits did not involve foreign DNA but were changes that could naturally occur. This move reflects the agency’s commitment to keeping regulatory approaches aligned with scientific advancements.  More information can be found here.

FDA Issues Safety Alert for Potentially Contaminated Shellfish from Oregon and Washington
June 5:  The FDA issued a safety alert advising restaurants and retailers not to serve or sell, and consumers not to eat, certain shellfish from Oregon and Washington harvested between 5/26/2024 and 5/30/2024 because they may be contaminated with the toxins that cause paralytic shellfish poisoning.  The safety alert can be found here.

FDA Releases Findings from Southwest Agricultural Region Environmental Microbiology Study
June 5:  The FDA released preliminary findings from an environmental study in the Southwest agricultural region, conducted with several partners, to understand how human pathogens such as E. coli survive, move, and potentially contaminate produce prior to harvest. The 5-year study, initiated after the 2018 outbreak of E. coli linked to leafy greens, collected environmental samples across a 54-mile area to observe pathogen variability.  The study confirmed that pathogens, including the E. coli pathogen, can survive in air and be distributed via dust to the environment.  More information can be found here.

FDA Urges Increased Testing and Restrictions Amid Bird Flu Outbreak in Raw Milk
June 11:  The FDA urged states to increase testing and restrictions on potentially infectious raw milk sold to consumers within their borders. However, officials in Wyoming and Iowa, where laws limit state oversight of raw milk, have stated that their hands are tied. While raw milk is already prohibited from being sold across state lines, some states allow its sale within their borders. The FDA recommends implementing surveillance programs to test for the H5N1 virus on dairy farms selling raw milk. The FDA continues to emphasize that pasteurized milk remains safe to consume.  More information can be found here.

Biden-Harris Administration Announce National Strategy to Reduce Food Loss and Waste
June 12:  The Biden-Harris Administration released the National Strategy for Reducing Food Loss and Waste and Recycling Organics which lays out a path for the United States to meet its national goal of reducing food loss and waste by 50% by 2030.  The FDA, USDA and EPA will collaborate to prevent food loss and waste, increase the recycling rate for all organic waste, and support policies that incentivize and encourage the prevention of food loss and waste and organics recycling.  More information can be found here.

Sunscreen Ingredient Found in Frozen Pizza and Other Foods Raise Concerns
June 14:  Titanium dioxide, an ingredient in sunscreen, is also used in foods such as pizza, salsa, and frosting to brighten colors in food and make it look more appealing.  Titanium dioxide is most prevalent in candy, coffee creamers and frosted or powdered baked goods. It is also found in chewing gums and mints.  There is growing concern about the potential health risks of eating titanium dioxide.  Some research, done mainly on animals, suggests that eating titanium dioxide might be linked to immune system problems, inflammation and DNA damage that could lead to cancer. New research in people has found a link between titanium dioxide consumption and inflammation in the gut. However, the science is not conclusive as some studies have not shown negative health effects. The European Union has banned titanium dioxide in food since 2022.  Some public-health advocacy groups have petitioned the U.S. Food and Drug Administration to not allow titanium dioxide to be used in foods. And some food companies are removing titanium dioxide from products.  More information can be found here.

FDA Grant Available to Establish Animal and Veterinary Innovation Centers
June 25:  The FDA announced a grant opportunity for cooperative agreements with academic research institutions to establish Animal and Veterinary Innovation Centers that would encourage development of innovative products to better support animal health and veterinary interventions, including those that prevent, control, or eliminate Highly Pathogenic Avian Influenza virus (bird flu) in animals, or interventions that reduce the circulation of the virus in the ecosystem.  More information can be found here.

USDA Proposes Rule for Fair Livestock and Poultry Markets
June 28:  The USDA proposed a new rule called Fair and Competitive Livestock and Poultry Markets to establish fairer, more competitive, and more resilient meat and poultry supply chains. This initiative is a part of the Biden-Harris Administration’s efforts to lower food costs and support farmers by addressing issues of unfairness and competitive injury in the livestock, meat, and poultry sectors.  The proposed rule clarifies enforcement of prohibitions on unfair practices under the Packers and Stockyards Act, intending to protect farmers, ranchers, and market participants. It defines clearer frameworks for identifying harmful market practices to ensure that livestock producers and poultry growers receive full value for their products.  Comments on the proposed rule are due August 27, 2024.   A copy of the proposed rule and fact sheet can be found here.  More information can be found here.

FDA Updates Priority Guidance Topics for Foods Program
June 28:  The FDA released an updated list of priority draft and final guidance topics for the FDA Foods Program for completion in 2024. New topics include dietary supplement master files, procedures and timeframes for New Dietary Ingredient Notification, foods derived from genome-edited plants, and more. An updated list of guidance documents under development are listed at the Foods Program Guidance Under Development webpage. Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to  https://www.regulations.gov/, using Docket FDA-2022-D-2088.  More information can be found here.

FDA and Wisconsin Warn Consumers to Avoid Diamond Shruumz Products
June 28:  The FDA, as well as the Wisconsin Department of Health Services, issued an advisory warning consumers and retailers to not eat, sell, or serve any flavor of Diamond Shruumz- Brand Chocolate Bars, Cones, and Gummies. The FDA, along with the CDC, America’s Poison Centers and state and local partners, are investigating a series of illnesses associated with eating Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies.   People who became ill from Diamond Shruumz-brand edibles reported a variety of severe symptoms including seizures, loss of consciousness, confusion, sleepiness, abnormal heart rates, high or low blood pressure, nausea, and vomiting.  As of June 25, there have been a total of 39 illnesses reported in 20 states, with half leading to hospitalization.  No illnesses have been reported in Wisconsin and no deaths have been reported. The FDA is working to determine the cause of these illnesses and the investigation is ongoing.  More information can be found here.

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Lawsuits

Judge Recommends Throwing Out Target Pomegranate Water Enhancer False-Advertising Suit
June 7:   A magistrate judge for the US District Court for the Middle District of Florida recommended that a proposed class action lawsuit, Broodie v. Target Corp., be dismissed.  The suit alleged that Target falsely advertised its Market Pantry-brand berry pomegranate flavored water enhancer as containing only natural flavors when it actually contains DL-malic acid, a synthetic flavoring. The plaintiff argued that this misrepresentation could deceive consumers who seek products without chemical additives. However, the court found that the plaintiff lacked standing to sue due to overly conclusory overpayment allegations. Additionally, the complaint was considered a “shotgun pleading” because the allegations were not properly incorporated into the plaintiff’s claims. As a result, the magistrate judge recommended dismissing the suit without prejudice and without leave to amend. 

Coca-Cola Temporarily Prevails in False Ad Lawsuit Over PFAS in Simply Orange Juice
June 10:   Coca-Cola temporarily defeated a proposed false advertising class action lawsuit alleging its Simply Tropical fruit juice contains PFAS.  The Simply Orange lawsuit centers around allegations that The Coca-Cola Company and its subsidiary, The Simply Orange Juice Company, falsely marketed their Simply Tropical fruit juice as containing only natural ingredients. The lawsuit claims that the juice contained per- and polyfluoroalkyl substances (PFAS).  The PFAS chemicals were not disclosed on the juice’s label, which promised a natural and organic product. A judge for the U.S. District Court for the Southern District of New York dismissed the class action, citing the lack of a strong connection between the testing results and the plaintiff’s actual juice purchase. While the case is not over, this ruling provides a temporary victory for Coca-Cola. Despite this dismissal, the Judge granted the Plaintiff leave to amend the complaint to address the deficiencies in standing. More information can be found here.

Judge Rules in Favor of Kroger Co. Over Cold-Pressed Avocado Oil Mislabeling Lawsuit
June 24:   A federal judge for the US District Court for the Central District of California ruled that a lawsuit alleging that Kroger Co. mislabeled its Cold-Pressed Avocado Oil lacked factual evidence showing the product was adulterated or that the product was advertised as “pure”.  Although the plaintiff in the case, McConnon v. Kroger Co., presented third-party lab tests indicating the oil’s composition differed from “pure” avocado oil, the product’s label did not actually use the word “pure.” The judge pointed out that the label only mentioned “avocado oil” without specifying purity.  The plaintiff also failed to clarify what “pure” meant—whether it implied exclusivity of avocados as the ingredient, absence of impurities, or lack of other oils. Due to the ambiguity in defining “pure” and insufficient details in the allegations, the claims under California consumer protection laws, breach of warranty, and misrepresentation were dismissed. 

Plant Based Foods Association Lacks Standing to Challenge Oklahoma Meat Labeling Law
June 25:   A federal judge for the US District Court for the Western District Oklahoma ruled that the Plant Based Foods Association (PBFA), along with Tofurky Co., lacks standing to contest an Oklahoma statute that prevents the mislabeling of products as meat unless they come from livestock. The court found that the members of the PBFA did not face any real risk of legal action under the Oklahoma Meat Consumer Protection Act since the law targets meat sellers. The PBFA contended that the law, established in 2020, was influenced by the cattle industry’s preferences in response to the growing market for plant-based products, and asserted that consumers are not confused by plant-based meat labels. Both the PBFA and Tofurky Co. sought to have the court reinterpret the law according to their interpretations. However, the judge said that judicial amendment of the statute would be inappropriate. The court’s view was that the statute’s goal is to ensure consumers are well informed and to protect traditional meat producers from decisions by uninformed buyers. The suit, Plant Based Foods Ass’n v. Stitt, was dismissed.

Ice Cream Manufacturer Sued Over Recalled Listeria-Contaminated Products
June 27:   Totally Cool Inc. is facing a proposed class action lawsuit after voluntarily recalling over 60 ice cream products due to the risk of Listeria monocytogenes contamination. The lawsuit, filed in the Southern District of New York, accuses the company of deceptive marketing for not disclosing the potential presence of the harmful bacteria on their product packaging. The recall includes items from brands like Friendly’s, Hershey’s, Jeni’s, and Dolcezza Gelato. The complaint asserts that consumers depend on the manufacturer to be transparent about their products’ contents, and criticizes the recall process as being insufficient, arguing that it’s unlikely to reach or compensate many affected consumers. Customers are required to return the recalled items to the original point of purchase for a refund, which the plaintiff contends is impractical as many would have disposed of the products upon learning of the recall. More information can be found here.

This Regulatory Update covers information from June 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 and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including funding to combat avian flu in the dairy industry, a ruling on “all natural” labeling, and the FDA’s determination on the GRAS status of tara flour.

FDA Updates

FDA Issues Final Rule to Modify Agricultural Water Provisions of the Produce Safety Regulation
May 6:  FDA issued a final rule updating pre-harvest agricultural water provisions for covered produce, excluding sprouts, under Subpart E of the FDA Food Safety Modernization Act Produce Safety Rule. The new rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.  The updated regulation will better address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.  The rule becomes effective July 5, 2024. More information can be found here.

FDA Says Tara Flour is an Unapproved Food Additive
May 15:  FDA determined that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s evaluation revealed that there is not enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS. In addition, there is no food additive regulation authorizing the use of tara flour in food. The FDA issued a memo detailing its assessment of the ingredient. More information can be found here.

FDA Extends Comment Period for Color Additive Certification Services Fees
May 28:  The FDA is extending the comment period for the reopening notice entitled “Color Additive Certification; Increase in Fees for Certification Services.”  The deadline for submitting comments is June 27, 2024.  More information can be found here.

Renewed U.S. Interagency Collaboration Aims to Cut Food Waste
May 30:  The FDA has renewed its commitment to the Federal Interagency Collaboration to Reduce Food Loss and Waste (FIFLAW) along with the USDA and EPA. The U.S. Agency for International Development (USAID) also joined the collaboration. The agencies want to reduce food loss and waste in half by 2030 and encourage consumers and retailers to utilize resources provided by the FDA to help reach this goal. Collaborative efforts include education, outreach, research, community investments, voluntary programs, technical assistance, policy discourse, and public-private partnerships. The participation of USAID is expected to improve international stakeholder engagement and optimize the use of government resources.  More information can be found here.

FDA’s Reorganization Approved for Unified Human Foods Program
May 30:  The FDA is undergoing a reorganization which includes the establishment of the Human Foods Program, a new model for field operations, and other modernizations, with implementation targeted for October 1, 2024. The restructuring seeks to make the FDA more efficient and responsive to changes in industry, technology, and global factors like climate change. According to FDA, the new Human Foods Program will strengthen the FDA’s preventative measures, enhance nutrition importance, improve partnerships, and better manage innovative food products and agricultural technology.  The FDA states that it will be better positioned to uphold the safety of the nation’s food supply, and respond to food-related emergencies, such as the 2022 infant formula shortages.  The reorganization includes realigning functions from existing food safety and regulatory offices under one program and renaming the Office of Regulatory Affairs to the Office of Inspections and Investigations to reflect its role in inspections, investigations, and product safety assurance.  More information can be found here.

FDA Extends Comment Period for Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
May 31:  The FDA is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food” by an additional 60 days.  Comments must be submitted by August 2, 2024.  More information can be found here.

FDA Achieves Lab Capacity for Mycotoxin Testing under LAAF Program
May 31:  The FDA announced that sufficient laboratory capacity has been reached for mycotoxins testing in foods related to imports under the Laboratory Accreditation for Analyses of Foods (LAAF) program.  The FDA’s LAAF program was created to enhance food testing standards and procedures. Importers must use accredited labs for mycotoxin food testing starting December 1, 2024. As the program expands capacity for other analytes, they will be listed on the LAAF Dashboard with the compliance date set at six months from the date a specific analyte is posted onto the Dashboard.  More information can be found here.

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FDA Warning Letters

Misbranded Food: FDA issued a warning letter to California Bread Company alleging that its Egg Bread product is adulterated because it contains a color additive which is unsafe.  FDA also alleged significant violations of the labeling regulations for foods and significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

Misbranded Cookie Dough: FDA issued a warning letter to Cookies and Milk LLC alleging that its ready-to-eat Peanut Butter Cup Edible Cookie is misbranded in that the product labels did not declare a peanut allergen and it failed to declare all the common or usual names of each ingredient used.

Low Acid Canned Food: FDA issued a warning letter to two foreign companies alleging violations of the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation.  The violations also render the LACF products adulterated.

Adulterated Dietary Supplements: The FDA issued a warning letter to Carbon Fire, LLC involving its 213° Metabolism Boosting Complex, which is labeled as a dietary supplement.  The FDA alleged the product is an adulterated dietary supplement because it contains a new dietary ingredient under the federal Food, Drug, and Cosmetic Act.

A database of warning letters can be found here.

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USDA Updates

FSIS Classifies NRTE Breaded Stuffed Chicken Products with Salmonella Over 1 CFU/g as Adulterated
May 1: The Food Safety and Inspection Service (FSIS) announced a final determination that not ready-to-eat (NRTE) breaded stuffed chicken products, which have Salmonella levels of 1 Colony Forming Unit per gram (1 CFU/g) or above, are considered adulterated under the Poultry Products Inspection Act (PPIA). Additionally, FSIS plans to implement verification procedures that include sampling and testing the raw chicken ingredients used in these NRTE breaded stuffed chicken products before they are stuffed and breaded.  The final determination will be effective May 1, 2025.  More information can be found here.

FSIS Announces Adjusted Dollar Limitations for Retail Exemptions
May 17:  The FSIS announced the dollar limitations on the amount of meat and poultry that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from federal inspection requirements. In accordance with FSIS regulations, for calendar year 2024, the value for the retail dollar limitation for meat and meat products (including Siluriformes) is $100,900, and the value for the retail dollar limitation for poultry and poultry products is $74,200. These dollar limitations will be effective on June 17, 2024.  More information can be found here.

FSIS Updates Guidance on Donations of Meat, Poultry and Egg Products to Non-Profits
May 23:  The FSIS has updated its Guideline to Assist with the Donation of Eligible Meat and Poultry Products to Non-Profit Organization.  The guideline addresses food donation questions from meat and poultry establishments and non-profit organizations and explains inspection, labeling, shipping requirements, and exemptions.  More information can be found here.

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Other Articles of Interest

Joint USDA, FDA and HHS Funding Announced to Fight Avian Flu in Dairy Industry
May 13:  The USDA, FDA and HHS are coordinating efforts to combat the spread of Avian Flu (H5N1) and provide financial support for lost milk production.  The USDA is providing financial support and assistance to improve biosecurity and mitigate spread among humans and animals. They are offering up to $2,000 per month for personal protective equipment (PPE) and worker studies, $1,500 for biosecurity plans, $2,000 for waste milk heat treatment, reimbursement for veterinary costs up to $10,000, and covering shipping costs for testing. There is also funding available for producers with milk production loss and state partnership for movement restrictions.  The HHS is investing $101 million through the CDC and FDA for testing, surveillance, and treatment. A $3 million wastewater pilot is also being launched. FDA announced an additional $8 million to help with pasteurization criteria validation, surveillance, lab capacity, biosecurity training, partner activities, and research collaborations.  More information can be found here.

U.S. Justice Department Proposes Regulation to Reschedule Marijuana
May 16:  The Justice Department announced a proposal to consider reclassifying marijuana as a Schedule III drug under the Controlled Substances Act, initiating a review process requested by President Biden. Marijuana has been listed as a Schedule I substance since 1970 but following scientific review by Health and Human Services and legal advice from the Office of Legal Counsel (OLC), the Attorney General is using his authority to potentially change its classification. The formal rulemaking process involves public notice, commentary, and a hearing. Until a final ruling, marijuana continues to be treated as a Schedule I drug.  More information can be found here, along with a copy of the notice of proposed rulemaking and the OLC memorandum.

Update on USDA H5N1 Beef Safety Studies
May 24:  The FSIS conducted tests on beef tissue from 96 cull dairy cows condemned at select FSIS-inspected facilities. Meat from condemned cows is prohibited from entering the food supply. On May 22, 2024, viral particles were detected in tissue samples, including muscle, from one cow.  To date, samples from 95 cows have tested negative for viral particles.  No meat from these dairy cattle entered the food supply and USDA is confident that the meat supply is safe.  More information can be found here.

FDA Proposes to Ban Brominated Vegetable Oil
May 24:  In November 2023, the FDA proposed a new rule to ban the use of brominated vegetable oil (BVO) in food. BVO is commonly used as an emulsifier and stabilizing agent in citrus sodas and other beverages. However, studies have shown adverse health effects in animals, leading the FDA to reconsider its safety.  BVO is a vegetable oil modified with bromine, and its use has been linked to thyroid and heart problems. BVO will be banned in California in 2027.  Japan, India, and parts of Europe have previously banned BVO in drinks and food products.  More information can be found here.

USDA Allocates $824 Million to Protect Livestock Health Amid H5N1 Concerns
May 30:  The USDA announced $824 million in new funding to protect livestock health to bolster efforts in response to the detection of the H5N1 virus in dairy cattle. Additionally, USDA is launching a Voluntary H5N1 Dairy Herd Status Pilot Program, which provides dairy producers with more options to monitor herd health and move cows efficiently while expanding understanding of the disease. The emergency funding will support rapid response activities, diagnostics, field response, and food safety studies, among other critical efforts. More information can be found here.

Federal Government on Course to Update Dietary Guidelines for Americans
May 31:  The 2025 Dietary Guidelines Advisory Committee is on schedule with the federal government’s five-year mandated timetable for another version of the Dietary Guidelines for Americans. The Committee is a collaborative effort between the U.S. Departments of Health and Human Services (HHS) and USDA and is made up of 20 members, drawn mostly from academic backgrounds.  Having completed the fifth of five scheduled work sessions, it is still unclear what recommendations the 2025 Dietary Guidelines for Americans will contain. Wine could be at risk of being eliminated as the World Health Organization pushes for prohibition. Potatoes appear safe, while lactose illnesses in certain minority populations have dairy under scrutiny. The USDA and HHS are jointly responsible for updating the guidelines.  More information can be found here.

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Lawsuits

U.S. Court of Appeals Rules in Favor of Kind Over ‘All Natural’ Labeling
May 1:   The U.S. Court of Appeals Second Circuit affirmed a summary judgment for Kind LLC against a group of buyers who claimed the company misled consumers by labeling products as “all natural”.  The Court said that the plaintiffs failed to establish through evidence how a reasonable buyer would understand the term.  The Court’s opinion closes out litigation that was launched in 2015 after the FDA issued a warning letter that Kind’s “healthy and tasty” packages constituted an implied nutrient content subject to federal regulations and that the products did not meet FDA’s saturated fat content requirements to describe food as healthy. A copy of the Court’s opinion can be found here.

Sports Drink Company Accused of Mislabeling Caffeine
May 9:   A proposed class action was filed against Prime Hydration LLC, a sports drink company founded by YouTubers Logan Paul and KSI, alleging that the company practices false and deceptive advertising by understating the caffeine in its energy drinks.  According to the complaint filed in the US District Court for the Southern District of New York, beverages in the Prime Energy line are advertised to contain 200 mg of caffeine but contain substantially more than that.  Prime’s audience includes a large share of adolescents. A copy of the complaint can be found here.

Publix ‘Naturally Flavored’ Cereal Bars Lawsuit Dismissed
May 23:   A federal judge for the U.S. District Court for the Middle District of Florida dismissed a proposed class action against Publix Super Markets Inc.  that alleged its apple and strawberry flavored cereal bars were deceptively advertised as “naturally flavored” when they contained DL-malic acid.  The judge said that none of the packaging labels state that the bars lack artificial flavor or that the bars include only flavor from a ‘natural’ strawberry or apple.  More information can be found here.

Bai WonderWater Maker Faces False Advertising Lawsuit over Artificial Sweetener
May 24:    A new proposed class action was filed in the US District Court for the Southern District of New York alleging that Bai Brands LLC deceptively advertised its flavored waters as free from artificial sweeteners despite containing artificial sugar replacements such as stevia leaf extract, erythritol, or monk fruit extract.  The consumers brought claims for deceptive trade practices and misrepresentation arguing that even though each of the alleged sweeteners comes from a plant, they undergo extensive industrial processing before being used as a sugar substitute and therefore are not natural. 

Barilla Italian Pasta Label Suit Gets Class Certified
May 29:    A federal judge for the U.S. District Court for the Northern District of California granted class certification to consumers alleging Barilla America Inc. deceived them into believing some of their pastas were made and sourced in Italy, because of packaging labels that said, “Italy’s #1 Brand of Pasta.”  The Consumers sued Barilla in 2022 over the Italy statement as being deceptive because the pastas are made in Iowa and New York.  The judge previously denied Barilla’s motion to dismiss the class action lawsuit, ruling that the plaintiffs had standing to sue the company.  More information can be found here.

This Regulatory Update covers information from May 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.