Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).
Emily Lyons
Emily grew up on a northern Illinois dairy farm, and now helps clients bridge the gap from farm to fork. She guides clients on complex regulatory issues as they bring dairy products, beverages, fruits and vegetables, processed foods and other agricultural goods to market. At the intersection of agriculture, food and environment, Emily handles compliance matters such as labeling, marketing, permitting and agency inquiries including the Food Safety Modernization Act, Pasteurized Milk Ordinance, USDA National Organic Program and bioengineered food disclosure standard, Generally Recognized as Safe status for food additives and food contact substances, and the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
FDA Allows Longstanding MOU with AAFCO To Expire
On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO ingredient review process would not be renewed on October 1, 2024 when the MOU is set to expire. The MOU, which has been in effect for the last 17 years, established guidelines by which AAFCO reviews the safety and efficacy of new animal feed ingredients under the guidance of FDA.
FDA Announces New Qualified Health Claim for Yogurt Products – With Limitations
Marketers of yogurt products may celebrate the latest approval by the Food and Drug Administration (“FDA”) of a new qualified health claim related to the consumption of yogurt and type 2 diabetes. However, producers of such products should also be cautious in presenting these claims on product labeling so as not to run afoul of limitations imposed by FDA related to this new qualified health claim.
Caffeine’s Wake-Up Call: Navigating Legal Risks for Highly Caffeinated Beverage Products
In the bustling landscape of consumer goods, caffeinated beverages stand out as a daily staple for millions of Americans. A recent shift towards “clean caffeine” and caffeine alternatives has further energized consumer demand for ready-to-drink caffeinated beverages.
Recently, however, the spotlight has turned to the highly caffeinated beverage industry for far less stimulating reasons, as cases of alleged caffeine overconsumption have led to severe health repercussions. As highly caffeinated beverages continue to expand their market share, it is crucial for ready-to-drink beverage brands to carefully consider their product’s caffeination levels and the way those products are labeled and/or marketed.
Will FTC’s New Endorsement Guidelines Dent Usage of Social Media Influencers in 2024?
In May 2022, when the Federal Trade Commission (FTC) proposed updates to its Guides Concerning Use of Endorsements and Testimonials in Advertising (Guides), it had been 13 years since the Guides were updated. Much has changed in the way that businesses marketed and sold their brands, products, and services over that period. While the use of social media marketing has been well established for the better part of the last decade, the use of social media influencers—that is, people who use their expertise, knowledge, and/or celebrity to promote ideas, products, services, and brands via the internet—has seen a dramatic uptick since the period preceding the COVID pandemic and is now estimated to be a $21 billion industry in its own right. The rise of this marketing approach—and the increasingly prevalent lawsuits against influencers and the companies they promote—played no small part in the FTC’s reconsideration of previous guidance, as evident from the finalized guidelines which were released June 29, 2023.
The question going forward is to what degree the new guidelines will change the way marketers approach the use of social media influencers. To get at the issue, it is helpful to review the substance of the FTC’s revisions.
FDA Releases Draft Guidance on Labeling of Plant Based Milk Alternatives
On February 22, 2023, the U.S. Food and Drug Administration (“FDA” or “Agency”) released draft guidance on labeling of plant-based milk alternatives (“PDMA”). This draft guidance is meant to clarify the FDA’s current view on the naming of plant-based foods that are marketed and sold as alternatives for milk in accordance with Sections 403(a)(1) and 403(i)(1) of the Federal Food, Drug, and Cosmetic Act. The draft guidance also provides recommendations on the use of voluntary nutrient statements comparing plant-based milk to cow’s milk.
TTB Considers Updates to Trade Practice Regulations
On November 9, 2022, the U.S. Alcohol and Tobacco Tax and Trade Bureau (“TTB” or “Agency”) announced that the Agency is considering updating the alcohol trade practice regulations for the first time in 20 years. The current trade practice regulations, codified at 27 C.F.R. parts 6 (tied house), 8 (exclusive outlets), 10 (commerical bribery) and 11 (consignment sales), prohibit certain practices that threaten the independence of retailers and/or give the industry members an unfair advantage over their competitors.
TTB Proposes to allow reference to distilled spirits on wine labels and in advertisements
The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently proposed amendments to 27 CFR Part 4 that would allow winemakers to reference added distilled spirits on labels and in advertisements. Currently, wine labels and advertisements are prohibited from including statements indicating that a wine contains a distilled spirit unless the wine is required to bear a statement of composition which references the use of a distilled spirit. While this 1930’s prohibition sought to protect consumers from misinformation, the TTB acknowledges that as the wine industry has evolved, the regulation has become inconsistent with the TTB’s mission. Allowing this additional information provides manufacturers flexibility and empowers them to communicate with consumers more accurately about their wine products.
FDA Issues Warning Letters to Companies Whose Products Are Intended for Use with Food-Producing Animals
On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies[1] concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing animals. These Warning Letters demonstrate the first time the FDA chose to focus on marketing CBD-containing products for use in food-producing animals, as opposed to pets, and the specific concerns related to such use. Food-producing animals, as defined by the FDA, include cattle (veal calves, beef cattle, and dairy cattle), swine, chickens, turkeys, and others (such as lambs).
FDA Issues Final Guidance for Voluntary Recalls
Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps companies should take to develop recall policies and procedures that include training, planning, and recordkeeping to reduce the amount of time a recalled product is exposed to the public.