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 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.
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.
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.
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.