AWG Regulatory Roundup — November 4, 2025
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- FDA Warning Letter Spotlight
- Wisconsin Becomes the Latest State to Seek Warnings on Food Labels
- California AG Sues Single-Use Plastic Bag Manufacturers<
- Litigation: What’s Trending? “Artificial” Ingredients, Protein Labeling, Slack-Fill, and Hypoallergenic Claims
- Hemp Happenings™ – Federal & State Updates
FDA Warning Letter Spotlight
Although we are in week 5 of the federal government shutdown, FDA Warning Letter activity remains steady. A recent letter highlights the importance of not overstating the role of inactive ingredients in OTC drugs. The agency took issue with the labeling of eye gel and drop products that allegedly presented an inactive ingredient – in this case, honey – as having an active (drug) effect due to statements on its website and YouTube videos that described the medical benefits of honey or otherwise suggested that “it is intended to furnish pharmacological activity for the treatment of a disease or condition.” Because honey is not an active ingredient permitted under the relevant OTC monograph (M018: Ophthalmic Drug Products for Over-the-Counter Human Use), the products are not lawfully marketed and therefore unapproved new drug products. It’s also worth noting that FDA has stated that ophthalmic drugs may pose an increased risk of harm because products applied to the eyes bypass some of the body’s natural barriers, and thus, this category has been an ongoing priority for the agency.
Wisconsin Becomes the Latest State to Seek Warnings on Food Labels
On October 15, 2025, a group of Wisconsin Assembly members introduced Assembly Bill 550, which, if passed, would require food manufacturers to include a warning statement on products that contain any of over 50 listed ingredients starting January 1, 2027. Ingredients on the list include Butylated hydroxyanisole (BHA), bleached flour, carrageenan, melatonin, potassium bromate, titanium dioxide, and several FD&C food colors. Similar (but not identical) to the law in Texas, the proposed warning statement reads “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.”
California AG Sues Single-Use Plastic Bag Manufacturers
California’s Attorney General filed a complaint against four plastic bag manufacturers for allegedly violating Senate Bill 270, which bans certain retail stores from offering consumers single-use plastic bags at check-out. If plastic bags are offered at check-out, the stores must charge at least $0.10 per bag and the bags must display the chasing arrows symbol or the term “recyclable,” with instructions on how to properly recycle the bags. The law places the responsibility for properly printing the chasing arrows symbol and instructions on bags on plastic bag producers, who must also obtain third-party certification that the bags comply with SB 270. The state alleges that the four defendant producers violated the law because, despite knowing their bags were not recyclable or not actually recycled in California, they continued to mark the bags as such.
Litigation: What’s Trending? “Artificial” Ingredients, Protein Labeling, Slack-Fill, and Hypoallergenic Claims
Several persistent trends continue to shape the class action landscape:
- Plaintiffs are relentlessly targeting food companies for “no artificial flavors or preservatives” claims on products that contain citric acid, DL-malic acid, or similar ingredients alleged to be artificial. This trend has even expanded into the pet food space.
- Cases are increasingly focused on labels that include protein content claims outside the Nutrition or Supplements Facts panel, but that omit the protein Percent Daily Value from the panel. In addition, plaintiffs continue to aim their sights at products, particularly plant-based products, where the stated protein Percent Daily Value is allegedly not properly adjusted using the Protein Digestibility-Corrected Amino Acid Score (PDCAAS).
- Slack-fill claims have surged again, with a rise in complaints alleging that food, supplement, and cosmetic products contain non-functional empty space that misleads consumers about the amount of product they are purchasing.
- Finally, in the cosmetics and OTC spaces, there has been an uptick in challenges alleging that “hypoallergenic” claims are false or misleading if the product contains any known allergens.
Hemp Happenings™ – Federal & State Updates
Although FDA’s position on Delta-8 THC and its concerns regarding its health risks are not new, a recent Warning Letter to a marketer of Delta-8 and Delta-9 THC products provides valuable insight into the agency’s position on cannabinoids more broadly. In the letter, after noting that the Delta-8 and Delta-9 THC gummies, cookies, and brownies are adulterated foods because they contain Delta-8 THC, an unsafe food additive, FDA also states that it knows “of no basis to conclude that any intended use in food of any cannabinoid satisfies the criteria for eligibility for GRAS status.” The agency also noted that the use of a Supplement Facts panel did not make the cookies and brownies dietary supplements because they are represented for use as conventional foods, and the FD&C Act “excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)].”
Noticeably absent in the letter, and in previous letters, is FDA’s commentary on the use of Delta-9 THC in conventional foods, especially given the continued growth and widespread presence of Delta-9 THC beverages in the market. However, states have continued cracking down on the presence of all forms of THC in hemp products. In addition, on October 24, 2025, a bipartisan coalition of 39 state and territory attorneys general sent a letter to congressional leaders urging them to “clarify the federal definition of hemp during the Fiscal Year 2026 appropriations process or through the reauthorization of the Farm Bill” to prevent the sale of intoxicating hemp-derived THC products, in particular synthetically-derived “Frankenstein THC products,” as the letter refers to them. It further notes that state efforts to address intoxicating hemp products have led to “an uneven and ineffectual patchwork of bans and regulations” that “will not stop the flood of mail-order THC products from streaming through interstate commerce.”
Meanwhile, Congress continues to consider options for regulating hemp-derived cannabinoid products, including determining the appropriate level of THC in such products and restrictions on synthetically-derived cannabinoids.
