Weekly FDA Roundup: PFAS in Cosmetics, a Children's Supplement Spiked with an Unapproved Drug, and a Holiday Recall Wave — Week of Dec 27–Jan 3
FDA's MoCRA report finds insufficient safety data for most PFAS in cosmetics; a children's growth supplement contained hidden ibutamoren; seven herbal products recalled in one sweep.
Weekly FDA Roundup: PFAS in Cosmetics, a Children's Supplement Spiked with an Unapproved Drug, and a Holiday Recall Wave — Week of Dec 27–Jan 3
FDA closed out 2025 on a cautionary note: a congressionally mandated report confirmed the agency cannot vouch for the safety of most PFAS used in cosmetic products, while a warning letter revealed a children's growth supplement containing a hidden unapproved pharmaceutical. Forty-three regulatory items crossed the wire this week — 22 recalls, 14 Federal Register notices, 6 warning letters, and one press release that the cosmetics industry had been anticipating for months.
By the Numbers
| Metric | Count |
|---|---|
| Total items this week | 43 |
| Recalls | 22 (14 Class I or II food/supplement) |
| Warning letters | 6 |
| Federal Register notices | 14 |
| Press releases | 1 |
| Single-company recall sweeps | 2 (A New Life Herbs: 7 products; First & Last Tavern: 3 sauces) |
Lead Story: FDA Says It Cannot Determine Safety of Most PFAS in Cosmetics
On December 29, FDA released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating per- and polyfluoroalkyl substances (PFAS) in cosmetic products. The bottom line is stark: the agency found that "toxicological data for a majority of these PFAS are incomplete or unavailable," leaving it unable to fully assess consumer risk.
The scope of the issue is significant. Based on mandatory cosmetic product listing data submitted to FDA, 51 different PFAS are intentionally used in 1,744 cosmetic formulations — everything from foundations and sunscreens to mascaras and moisturizers. FDA evaluated the 25 most frequently used PFAS, representing approximately 96% of PFAS intentionally added to cosmetics. Of those:
- Five PFAS appeared to present low safety concerns under their intended conditions of use
- The safety of most PFAS could not be definitively established
- One PFAS was identified as having a potential safety concern with significant remaining uncertainty
Commissioner Marty Makary framed it through the MAHA lens: "Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety. This lack of reliable data demands further research."
Key Developments
Children's Growth Supplement Contained Hidden Unapproved Drug
Agebox Inc. received a warning letter dated December 19, 2025 (published December 30) for its iKids-Growth IGF-1 Support Day Formula and Night Formula — supplements marketed online and on Facebook to help children grow taller. FDA laboratory analysis confirmed both products contain ibutamoren mesylate (MK-677), an undeclared ingredient that does not appear on the label.
This is not a trace contaminant situation. Ibutamoren is a growth hormone secretagogue under active clinical investigation as a new drug — and because substantial clinical investigations have been made public, it is legally excluded from the dietary supplement definition under 21 U.S.C. 321(ff)(3)(B)(ii). FDA confirmed ibutamoren can cause serious side effects including fluid retention, fatigue, muscle pain, altered insulin sensitivity, and potential congestive heart failure risk. Long-term effects in children are unknown.
The products were marketed to parents with language like "unlock your child's growth potential" and claimed to increase IGF-1 levels. The company operated via agebox.com and Facebook, with the products distributed through retail and online channels.
Unipack LLC: Data Integrity Failures in Pharmaceutical Manufacturing
Unipack LLC (South Plainfield, NJ) was cited for serious CGMP violations following an inspection of its drug manufacturing facility in June 2025. The warning letter — one of the more detailed data integrity letters published this quarter — documents a pattern that FDA treats as indicative of systemic failure:
- Analysts had administrative rights to delete and alter data in chromatographic systems, with documented "deleted system" and "deleted project" errors
- Multiple HPLC injections were not processed, with results generated for only a fraction of runs
- Out-of-specification results were invalidated without scientific justification and products released for distribution
- Laboratory notebook entries were not contemporaneous; sample weights recorded on adhesive notes
Unipack manufactures suppository drug products. FDA recommended an independent third-party consultant and flagged that CDER may withhold approval of new applications listing the firm until violations are resolved.
A New Life Herbs: Seven-Product Recall Sweep
A New Life Herbs, LLC had seven products recalled on December 31 in a single enforcement sweep — all classified Class II. The products span herbal tinctures, capsules, and topical preparations:
- Anti-virus Herbal Supplement (alcohol tincture with forsythia, sumac berries, pine needles)
- Chaga Mushroom Herbal Supplement
- Boswellia (Frankincense) Supplement
- Baby Soothe (catnip, chamomile — marketed for infant colic and teething)
- Baby Allergy (echinacea, Oregon grape root — marketed for infants)
- Ear Drops (mullein flower tincture, marketed as antibiotic/pain-relieving)
- Pain Away (wood betony, white willow bark in glycerin)
- Organic Ginger Root Supplement
- Sinus Cap
The product labeling on several items makes unsubstantiated drug claims ("antibiotic properties," "stops viral replication," "anti-cancer properties"). Class II indicates potential for temporary adverse consequences, but the infant-targeted products — Baby Soothe and Baby Allergy — are the most immediately concerning from a consumer safety standpoint.
Allergen Recalls Hit Holiday Products at Major Retailers
Several Class I recalls (meaning use could cause serious adverse health consequences) emerged from holiday-season products at major retailers:
- Wegmans Food Markets / Mellace Family Brands: Wegmans Deluxe Mixed Nuts (34 oz. and 11.5 oz. sizes) recalled Class I — likely undeclared allergen
- Silvestri Sweets dba Carousel Candies: Two Choceur Holiday Bark products (Pecan Cranberry & Cinnamon; Cookie Butter) recalled Class I — distributed to Aldi stores during holiday season
- Mondelez Global LLC: Ritz Peanut Butter Cracker Sandwiches, 27.6 oz. 20-count pack, Class II
The timing — late December, when pantry staples and holiday gifts are being opened — adds urgency for any of these products still in the distribution chain.
COVID-19 Diagnostic EUA Revocations Continue
On January 2, FDA published notice of the revocation of two Emergency Use Authorizations for in vitro diagnostic devices used for COVID-19 detection and diagnosis. This continues a years-long wind-down of pandemic-era authorizations as the public health emergency has concluded. Manufacturers holding COVID-19 EUAs should be tracking their authorization status and planning transition to standard 510(k) clearance or De Novo pathways for any products they intend to continue marketing.
New World Screwworm: Elanco Gets Animal Drug EUAs
FDA authorized two Emergency Use Authorizations for Elanco US Inc. animal drug products — one for dogs/puppies and one for cats/kittens — to treat infestations caused by New World screwworm (Cochliomyia hominivorax) larvae. The EUAs follow the HHS Secretary's August 18, 2025 declaration of a public health emergency involving the parasite, which had been advancing through Central America toward the U.S. border. Veterinarians treating companion animals in affected areas should be aware these products are now legally available under EUA conditions.
The Bigger Picture
This week's activity reflects patterns we've tracked across 711 items in the last 90 days. Salmonella leads all substances at 69 items — nearly double the next pathogen (Listeria, 34). Botulinum toxin-related recalls are running at 29, reflecting continued scrutiny of low-acid shelf-stable foods. On the drug enforcement side, semaglutide and tirzepatide enforcement (29 items each over 90 days) continues at pace, though this week was quiet on GLP-1 compounding — holiday schedule likely pushed those letters to the January queue.
The PFAS cosmetics report and the Agebox letter together represent a harder line on what MoCRA expects from the cosmetics industry and what FDA tolerates in the supplements-as-drug-delivery space. Neither is new enforcement territory, but the specificity of the PFAS data gap acknowledgment and the lab-confirmed ibutamoren finding in a children's product signal that FDA's post-MoCRA science infrastructure is producing actionable results.
What to Watch
- GLP-1 compounding enforcement: Semaglutide and tirzepatide enforcement have generated 56 combined items over 90 days. January typically sees a catch-up surge after the holiday lull. Any compounder still operating without 503A/503B registration or PMTA exemption is exposed.
- PFAS cosmetics regulatory trajectory: The FDA report creates a record. State AGs and plaintiff firms will use it. Expect ingredient transparency pressure to increase across the sector in Q1 2026.
- Supplement labeling claims: The Agebox letter is a data point in a larger pattern. FDA has been quietly lab-testing products marketed with drug-like claims. If your supplement label includes language about specific physiological mechanisms — IGF-1 pathways, hormone modulation, "antibiotic properties" — that's the profile getting picked up.
- OTC Monograph user fees (FY2026): FDA published updated OTC Monograph Order Request fee rates for FY2026 this week. Any company planning to file an OMOR this fiscal year should verify the current fee schedule before submission.
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