AWG Regulatory Roundup — February 11, 2025
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- The Latest on MoCRA
- Amazon Testing Requirements Expanded to Include Joint Health Supplements
- NAD Targets Age Mismatch in Substantiation, Distinguishes Consumer Reviews from Advertising Claims
- AAFCO Approves New Animal Food Ingredient Pathway
The Latest on MoCRA
Although several requirements of the Modernization of Cosmetics Regulation Act (MoCRA) have gone into effect, full implementation of the law (signed in December 2022) continues to roll along slowly. It may slow down even further due to leadership transitions at FDA and HHS. Here, we run down the status of MoCRA requirements, including what’s in effect, what’s still on the way, and what to expect in the year ahead.
Currently in effect:
- Product listing updated annually
- Biennial manufacturer/processor facility registration
- Serious adverse event reporting and related requirement that all cosmetic product labels include the domestic address, phone number, or electronic contact information of those responsible for adverse event reporting
- Safety substantiation for each cosmetic product and related recordkeeping requirements
- Mandatory recall authority for adulterated or misbranded cosmetics, where the use of or exposure to the cosmetic will cause serious adverse health consequences or death
Not yet implemented:
- Standardized testing for talc products (Proposed Rule issued December 27, 2024)
- Fragrance allergen labeling requirements (statutory deadline of June 29, 2024 for the Proposed Rule, but likely to be further delayed)
- Good Manufacturing Practices (statutory deadline of December 29, 2024 for the Proposed Rule; now expected October 2025)
- Report on the use of PFAS in cosmetic products (statutory deadline of December 29, 2025)
Amazon Testing Requirements Expanded to Include Joint Health Supplements
Dietary supplements marketed for joint health are the latest category requiring third-party testing to be sold on Amazon. Last year, Amazon announced a new policy requiring weight management, sexual enhancement, and sports nutrition/muscle-building products to be verified through a third-party Testing, Inspection, and Certification (TIC) organization. Joint health supplements currently listed in the Amazon store will have 90 days to comply with the new requirement.
NAD Targets Age Mismatch in Substantiation, Distinguishes Consumer Reviews from Advertising Claims
In a recent decision, the NAD recommended Olly discontinue the claim “supports a calm and relaxed mood,” among other mood and focus claims for its Kids Chillax, a supplement marketed to children ages 4-15 years. NAD found that the anxiety level assessment methods used in an Olly-commissioned study were not reliable for children ages 4-5 and that Olly’s other scientific literature was generally targeted at children older than 8, without mention of children younger than 6. Olly intends to appeal this part of NAD’s decision.
However, NAD denied a challenge to consumer reviews on Olly’s website, which the challenger argued conveyed the message that Kids Chillax helps with ADHD, behavioral problems, anxiety, and sleep troubles, and therefore the reviews should be deemed false or misleading implied claims. Reaffirming FTC’s position in its Final Rule on the Use of Consumer Reviews and Testimonials and associated FAQs, NAD explained that an advertiser has met its obligation when it posts authentic product reviews that are “independent, systematically representatively collected consumer reviews,” and does not have an obligation to substantiate these reviews. AWG’s Jennifer Adams also provided insights on this decision in this NutraIngredients article.
AAFCO Approves New Animal Food Ingredient Pathway
AAFCO announced a new animal food ingredient submission pathway whereby approved ingredients will be included in AAFCO’s Official Publication, replacing the former Ingredient Definition Process that expired at the end of its Memorandum of Understanding with FDA. The new pathway will include a scientific review panel of diverse subject matter experts who will evaluate potential ingredient submissions from industry and provide recommendations to AAFCO membership for final approval.
Thanks for reading! — Rend Al-Mondhiry, Editor
