FDA Draft Guidance: Records Access Authority for Cosmetic Products

On Jan. 21, the US FDA issued draft guidance on its authority to access and copy records related to cosmetic products under sections 605, 610, and 704 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act). Those sections are:

• 605 (adverse event reports);
• 610 (serious adverse health consequences or death to humans; SAHCOD); and
• 704 (inspections) of the FD&C Act.

The draft guidance can be accessed here.

Submission of electronic or written comments on this draft guidance is due by March 23, 2026.

The guidance provides answers to common questions that might arise about these records access provisions and FDA’s current thinking regarding their implementation, said the Agency.

Section 605 specifies that the Secretary has access to adverse event records during an inspection under section 704 (21 U.S.C. 374). Section 610 authorizes FDA to access and copy certain records if FDA has a reasonable belief that a cosmetic product, including an ingredient in the product, and any other cosmetic product that FDA reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans (SAHCODH). Section 704(a)(1) of the FD&C Act, as amended by section 3504 of MoCRA, extends FDA’s inspectional authority over all records and other information described in sections 605 and 610 from facilities that manufacture and process cosmetic products, when the standard for those sections apply. This draft guidance focuses on the authorities to access records described in sections 605 (adverse event reports), 610 (SAHCODH), and 704 (inspections).

FDA will consider comments on costs or cost savings the guidance may generate, relevant for Executive Order 14192, titled “Unleashing Prosperity Through Deregulation,” which was signed by President Trump on Jan. 31, 2025.

Submit electronic comments through the Federal eRulemaking Portal. To submit a comment with confidential information, submit as a written/paper submission following the Agency’s guidelines.