This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including draft guidance on menu labeling, PFAS found in food processing wastewater, a sustainability lawsuit for seafood, and more.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FDA Issues Draft Guidance on Menu Labeling
December 14: The FDA announced the availability of a draft guidance for industry entitled “Menu Labeling: Supplemental Guidance for Industry (Edition 2).” The draft guidance, when finalized, will update existing guidelines to address the voluntary declaration of added sugars and the voluntary declaration of nutrition information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 Comments on the draft Guidance will be accepted until February 12, 2024.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.
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.
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.
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.