The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The draft guidance document provides answers to frequently asked questions about certain authorities for FDA to access records related to cosmetic products. It is intended to inform regulated industry about the Agency’s current thinking regarding the criteria, process, and expectations for FDA’s access to these records.
DATES: Submit either electronic or written comments on the draft guidance by March 23, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as follows:
Electronic Submissions: Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or c