AWG Regulatory Roundup — March 11, 2025
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- Update on FDA Commissioner Hearing
- Connecticut Proposes Anti-Shrinkflation Bill
- States Turn Focus to Food Additives and “Ultra-Processed Foods”
- P&G Scores a Partial Win in Tampon Lawsuit
- Protein Claims Continue to be a Target for Plaintiffs
- When is a Product “Plant-Based”?
- California Corner: DTSC Takes Aim at Fragrance Chemicals and QACs in Personal Care & Cleaning Products
Update on FDA Commissioner Hearing
On March 6, 2025, the Senate Health, Education, Labor and Pensions Committee held a hearing on the confirmation of Dr. Marty Makary, President Trump’s nominee to serve as FDA Commissioner. Makary, a pancreatic surgeon at John Hopkins University, is expected to be confirmed later this month or in early April. According to news reports, during the hearing, Dr. Makary stated he is committed to reviewing additives, colorings, and other chemicals used in food, “a subset of which are concerning.”
Connecticut Proposes Anti-Shrinkflation Bill
The Connecticut legislature is considering a first-of-its-kind anti-shrinkflation bill (House Bill 6856), which would require companies to provide clear and conspicuous notice for at least 12 months when they reduce the quantity, amount, weight, or size of a product without adjusting the price. The scope includes essential consumer goods, including food, diapers, baby formula, pharmaceutical products, and prescription drugs, and would apply to distributors, manufacturers, retailers, suppliers, and wholesalers.
States Turn Focus to Food Additives and “Ultra-Processed Foods”
Following California’s lead, several states have introduced bills aimed at banning certain food additives and restricting “ultra-processed foods,” including the following:
- Arizona HB 2164 would ban foods containing potassium bromate, propylparaben, titanium dioxide, brominated vegetable oil, Yellow No. 5 and 6, Blue No. 1 and 2, Green No. 3, and Red No. 3 and 40, as well as ultra-processed foods in school meals. Utah HB 402 has similar provisions.
- Delaware SS 2 seeks to ban Red No. 3 in foods.
- Florida SB 560 would prohibit the manufacture, distribution, or sale of food that contains certain chemicals, including potassium bromate, propylparaben, Blue No. 1, Yellow No. 5, benzidine, butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT).
- Illinois SB 93 and Vermont HB 260 would prohibit brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3 in foods.
- Maryland HB 1208 would also prohibit brominated vegetable oil, potassium bromate, and propylparaben in foods, and foods containing Red No. 3 would be required to include a label warning alerting consumers to the presence of Red No. 3.
- Texas HB 3137 proposes to prohibit foods that contain aspartame, artificial flavoring, propylparaben, ADA, BHA, BHT, color additives, PDWS, MSG, TBHQ, partially hydrogenated oils, sodium benzoate, sodium nitrate, sodium nitrite, or methylparaben.
- Legislation in West Virginia would prohibit foods containing Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3, and those containing potassium bromate and propylparaben.
P&G Scores a Partial Win in Tampon Lawsuit
Following a complaint against The Proctor & Gamble alleging that certain Tampax tampons expose consumers to harmful levels of lead, a California District Court granted in part and denied in part P&G’s motion to dismiss. The complaint stated that prominent messaging on the packaging such “#1 U.S. GYNECOLOGIST RECOMMENDED TAMPON BRAND,” “FREE OF PERFUME,” “FREE OF ELEMENTAL CHLORINE BLEACHING,” “TAMPON FREE OF DYES,” and “CLINICALLY TESTED GENTLE TO SKIN” misleads reasonable consumers to believe the products are safe and free from potentially harmful elements and ingredients, including lead. Although the court declined to apply the doctrine of primary jurisdiction, it granted the motion to dismiss with leave to amend after determining that plaintiffs failed to explain why the test results for certain sizes of tampons can be extrapolated to other products. In addition, plaintiffs did not establish that P&G had a duty to disclose the lead levels in the product. The court also rejected defendant’s argument that the complaint is “an impermissible attempt to bring a ‘back-door Proposition 65 claim.’”
Protein Claims Continue to be a Target for Plaintiffs
Complaints (and demand letters) continue to pile up, alleging the % Daily Value calculation on Nutrition/Supplement Facts Panels is miscalculated or omitted on products making protein claims. Plaintiffs argue that many products fail to calculate the % Daily Value using the Protein Digestibility-Corrected Amino Acid Score (PDCAAS) or fail to include the Value altogether, which is required when a front-label protein claim is made. Vegan products with plant-based proteins such as pea and rice have a PDCAAS lower than 1.0 and are the primary targets.
When is a Product “Plant-Based”?
A recent complaint alleges that cleaning products (ranging from laundry to pet products) are falsely marketed as “plant-based” and marketed as such on the product website. The complaint cites the FTC’s Green Guides, which require marketers to substantiate consumers’ reasonable interpretations of “plant-based” claims. In this case, the plaintiff alleges that consumers reasonably believe “plant-based” means the products contain only water or plant-derived ingredients, with minimal processing, and are willing to pay a premium for such products. However, the products at issue contain ingredients the plaintiff argues are non-plant-derived, such as cocamidopropyl betaine, decyl glucoside, polysorbate 80, and sodium chloride. Like other complaints targeting “plant-based” claims, the plaintiff also points to “natural” and imagery that reinforces the representation that the products contain only plant-derived ingredients.
California Corner: DTSC Takes Aim at Fragrance Chemicals and QACs in Personal Care & Cleaning Products
As part of its Safer Consumer Products Program, California’s Department of Toxic Substances Control (DTSC) is in the early stages of evaluating fragrance chemicals in personal care and household cleaning products, including their hazard traits and use. DTSC states its assessment is intended to address fragrance chemicals that it claims are “ubiquitous in personal care and cleaning products but are seldom disclosed on the ingredient label,” and that consumers’ exposure to fragrance chemicals is “widespread and has been associated with various health problems.” DTSC plans to release a public background document in late 2025 and will hold a public workshop in early 2026.
DTSC is also evaluating the hazards of quaternary ammonium compounds (QACs) and their uses in cleaning and personal care products. In its Background Document on Quaternary Ammonium Compounds in Cleaning Products and Beauty, Personal Care, and Hygiene Products, DTSC has identified 263 unique QACs used in 78 product categories. DTSC also specifically draws attention to cocamidopropyl betaine as present in 60% of all shampoo products, while 32 other QACs were present in only one product each. Comments received by DTSC on the Background Document may be viewed here.
