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.
FDA Warning Letters
A database of warning letters can be found here.
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.
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.
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.