FDA Records Access Authority for Cosmetics: Draft Guidance Now Available

The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The document addresses frequently asked questions about FDA’s authority to access records related to cosmetic products.

The guidance is intended to help regulated industry understand FDA’s current thinking on the criteria, process, and expectations for when and how the Agency may request access to records. It reflects FDA’s implementation of authorities established under the Modernization of Cosmetics Regulation Act (MoCRA).

What the Draft Guidance Covers

• When FDA may request access to cosmetic product records
• The types of records that may be subject to review
• How FDA expects requests to be made and fulfilled
• The Agency’s approach to exercising this authority
• Common questions from industry on scope and process

Why This Matters

MoCRA expanded FDA’s oversight of cosmetics, including new authority to access certain records in specific circumstances. This draft guidance provides insight into how FDA plans to apply those authorities in practice and what companies should expect if records are requested.

EAS Perspective

As FDA continues implementing MoCRA, guidance such as this signals a shift toward more defined operational expectations for cosmetics firms. Companies should review their recordkeeping practices and ensure they can respond efficiently and accurately to any FDA request.

EAS will continue monitoring FDA guidance and provide updates as this document moves toward finalization.