The U.S. Food and Drug Administration (FDA) has taken several steps in recent months to enhance safety and regulatory oversight for cosmetics and pharmaceuticals, and to support hair loss treatments. Specific actions include: reviewing PFAS in cosmetics, proposing MoCRA-conferred recall guidance, enforcing compliance through warning letters and recalls, and advancing trials for a new hair loss treatment.
FDA Report Reveals Gaps in PFAS Safety Data
On Dec. 29, 2025, the FDA released a report, under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), evaluating the safety of per- and polyfluoroalkyl substances (PFAS) in cosmetics. The report revealed 51 PFAS are used in 1,744 cosmetic formulations, the top five categories of which are: eye shadows, face and neck products (leave-on), eyeliners, face powders and foundations.
To assess safety, the FDA evaluated the 25 most frequently used PFAS, representing approx. 96% of PFAS intentionally added to cosmetic products. The agency found that "toxicological data for a majority of these PFAS are incomplete or unavailable."
While five PFAS were deemed to present low safety concerns under conditions of use, one was flagged for potential risks — perfluorohexylethyl triethoxysilane was identified as having a potential safety concern when used in body lotion at the highest use level. The FDA emphasized the need for more comprehensive data and pledged to monitor emerging scientific evidence to address these gaps.
Draft Guidance on Mandatory Cosmetic Recalls
On Dec. 18, 2025, the FDA announced the availability of a draft guidance document titled: "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." This guidance, also stemming from MoCRA, aims to clarify the FDA's authority to mandate recalls of adulterated or misbranded cosmetics that pose serious health risks.
The draft guidance outlines criteria for mandatory recalls, the process the FDA will follow, and expectations for industry compliance.
For example:
If FDA determines that (1) there is a reasonable probability that the cosmetic is adulterated under section 601 of the Act or misbranded under section 602 of the Act and (2) there is a reasonable probability that the use of or exposure to the cosmetic will cause SAHCOD (serious adverse health consequences or death), FDA will provide the responsible person with an opportunity to voluntarily cease distribution and recall the cosmetic (section 611(a) of the FD&C Act).
- The FDA will notify the responsible person of this opportunity in writing. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by FDA, FDA may require the responsible person to immediately cease distribution of such cosmetic.
- The FDA will provide the responsible person who is subject to such an order the opportunity for an informal hearing. If a hearing is granted by the FDA, it will be held no later than 10 days after the date of issuance of the order and address whether adequate evidence exists to justify the order (section 611(b) of the FD&C Act). The informal hearing will be conducted in accordance with the procedures in 21 C.F.R. part 16, Regulatory Hearing Before the Food and Drug Administration.
- After providing an opportunity for an informal hearing, as described in section 611(b), the FDA will either:
- vacate the order, if FDA determines that inadequate grounds exist to support the actions required by the order;
- continue the order ceasing distribution of the cosmetic until a date specified in such order; or
- amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the FDA regarding such recall.
Stakeholders are encouraged to review the draft guidance and submit comments to help shape the final document by Feb. 17, 2026.
Warning Letter Issued to Private Label Skin Care, Inc.
The FDA issued a warning letter on Dec. 18, 2025, to Private Label Skin Care, Inc., citing significant violations of Current Good Manufacturing Practice (CGMP) regulations at its Canoga Park, California facility. The inspection, conducted in June 2025, revealed failures in quality control oversight, including the distribution of adulterated over-the-counter (OTC) drug products containing elevated impurities.
Additionally, according to the letter, the company failed to properly list 21 OTC drug products in the FDA’s electronic Drug Registration and Listing System, rendering them misbranded under federal law.
The cited products lacking drug listings include:
Age Defense SPF 45
The Treatment On the Daily SPF 45
100% Mineral Tinted SPF
Healthy Glow Tinted BB Cream SPF 44+
The Treatment Let’s Get Physical Tinted SPF 44
Dermlogic Anti-Aging Resurfacing Peel Pads
Even GLO Brightening Pads
Physical Daily Defense SPF 40
Acne Clearing Serum
Matte Tinted SPF
Fresh Faced Tinted SPF 44
Hydralite Moisturizer
Pigment Correcting Pads
Bye, Bye Blemish
Papaya Enzyme Cleanser
Clear Defense SPF 45
Detox Mask
Pore Refining Cleanser 2% Salicylic Acid
Sheer Defense Tinted SPF 46
Hydro Essence SPF 40
Micro Peel Pads
The FDA has demanded corrective actions, including a comprehensive quality control assessment and remediation plan, to ensure compliance with CGMP and drug listing requirements.
Gold Star Distribution Recalls Various Products Over Unsanitary Conditions
On Dec. 26, 2025, Gold Star Distribution, Inc., announced a recall of all FDA-regulated products stored at its Minneapolis facility due to unsanitary conditions, including rodent and avian contamination. The recall affects drugs, medical devices, cosmetics, dietary supplements, human food and pet food distributed to multiple retail locations across three states.
The FDA inspection revealed the presence of rodent excreta, urine and bird droppings, which pose significant health risks, including potential Salmonella contamination. The full Gold Star product list is available on the FDA website but a couple examples include beauty bar and antibacterial soaps.
Consumers and retailers are advised to destroy affected products and contact Gold Star for refunds. No illnesses have been reported to date but the FDA urges consumers to consult health care providers if they experience adverse reactions.
Extended Release Oral Minoxidil Treatment for Hair Growth Advances to Phase III Trials
In a promising development for hair loss treatment, Veradermics Inc., a dermatologist-founded biopharmaceutical company, announced its oral hair-growth pill, VDPHL01, is moving into Phase III clinical trials. Described as the first-ever extended-release oral minoxidil, the treatment is designed to treat pattern hair loss and, if approved, would be the first FDA-approved oral minoxidil specifically developed for hair growth.
Key Milestones in Clinical Trials
Veradermics recently completed enrollment in its Phase II/III trial for male pattern hair loss, involving 519 participants in a randomized, double-blind, placebo-controlled study. The trial evaluated two dose strengths (8.5 mg once-daily and twice-daily) over 52 weeks, with primary endpoints including changes in non-vellus hair count and patient-reported hair coverage benefits at 24 weeks. Early data from the trial showed:
- An average increase of 47.3 hairs/cm² in non-vellus target area hair count at four months, with gains of 37.5 hairs/cm² observed as early as two months.
- 90.5% of participants reported improved hair coverage at four months.
- 95% of participants expressed increased satisfaction with their hair coverage after four months of treatment.
- The treatment was generally well tolerated, with no serious adverse events, including no cardiac-related issues.
A Non-Hormonal Alternative
According to the company, VDPHL01 is designed to provide a non-hormonal alternative to finasteride, the only currently approved oral prescription for hair loss, which is can be associated with hormonal side effects. The extended-release formulation ensures consistent exposure to hair follicles while avoiding blood-level spikes that could lead to cardiovascular side effects, Veradermics reports.
Expanding Trials for Men and Women
In addition to the completed Phase II/III trial, Veradermics is actively enrolling participants in a second Phase III trial for men and a Phase II/III trial for women. Full data from these trials is expected this year (2026), potentially paving the way for a new standard in hair loss treatment.
FDA Commitment to Public Health
The described actions underscore the FDA's commitment to protecting public health by addressing safety concerns, enhancing regulatory clarity and fostering innovation in treatment options.
