As 2026 began, the U.S. Food and Drug Administration (FDA) unleashed a series of regulatory heavy blows. Within just three weeks, the FDA released two key documents concerning PFAS (Permanent Chemical Assays) and the right to access records. These releases were not accidental, but rather a direct result of the full implementation of the Cosmetic Regulatory Modernization Act of 2022 (MoCRA). For companies expanding into the U.S. market, the compliance threshold has been raised once again.

I. PFAS Survey Report: 51 Ingredients Named, Data Gap Remains a Challenge

Key Findings:

Scale：The FDA identified 51 PFAS compounds intended for use in cosmetics, involving 1,744 product formulations.

Key monitoring area：The agency has prioritized 25 substances for toxicological review.

Safety Conclusion： Currently, toxicological data for most PFAS ingredients is severely insufficient, making it difficult to determine their safety. Only 5 PFAS are considered to pose a low safety risk under current conditions of use.

Special Warning：  The use of an ingredient called "perfluorohexylethyltriethoxysilane" in body lotions is listed as a potential risk item, requiring further data verification.

Status quo：Currently, there are no mandatory federal bans on PFAS, but the FDA has clearly stated that it will continue to monitor the situation. This means that companies need to assess their supply chains in advance and find alternatives to prevent regulatory surprises.

II. Guidelines on the Right to Access Records: What's in the FDA's "inspection kit"?

On January 21, 2026, the FDA released a draft industry guidance regarding access to records under MoCRA Sections 605 and 610. This signifies that the FDA has unprecedented "voice" in on-site audits of cosmetic companies. 

1. Routine Inspection:

Adverse reaction records are mandatory. During routine inspections, the FDA has the right to access all adverse reaction records of the company (regardless of whether they are defined as "serious").

Retention Period: Most companies are required to retain records for 6 years; small businesses are required to retain records for 3 years.

 2. Urgent Access: 

When a Product is Suspected of Being "Toxic." If the FDA has reason to suspect that a product may cause serious health consequences or even death, its access scope will be significantly expanded, including: 

 1) Safety Substantiation Documents 

 2) Laboratory Test Results and Production Records 

 3) Analysis Reports of Raw Materials and Finished Products 

 4) Distribution Lists and Related Internal Documents 

Note: Although the FDA does not have the right to request product formulations, pricing data, or irrelevant personnel records, refusing to provide records within the scope of compliance will be considered a violation of the law.

III. How Should Companies Expanding Overseas Respond? 

With the deepening of MoCRA regulations, the era of "naked" cosmetics in the US market has come to an end. 

We recommend that relevant companies:

Self-check ingredient lists: Immediately verify product listings to identify whether they contain any of the 51 PFAS ingredients mentioned in the report.

Improve traceability records: Establish comprehensive safety substantiation documentation and an adverse reaction tracking system.

Collaborate on compliance: Pay attention to the public comment period for the draft guidance, and consult professional compliance agencies if necessary to ensure that every step from the laboratory to the shelf can withstand FDA on-site audits.