MoCRA gave FDA two new authorities over cosmetics: records access under section 610 of the FD&C Act and mandatory recall under section 611. On October 23, 2026, FDA announced its final guidance on mandatory cosmetic recalls, which adopts the December 2025 draft without substantive changes. FDA's January 2026 guidance on records access is still a draft.
Three routes to your records
- Section 605: during an inspection under section 704, the responsible person must give FDA access to its adverse event records, kept for six years, or three for qualifying small businesses.
- Section 610: if FDA reasonably believes a cosmetic product or ingredient is likely to be adulterated such that use or exposure threatens serious adverse health consequences or death, responsible persons and facilities must, on credentials and written notice, let FDA access and copy the records needed to assess it, including for other products likely to be affected in a similar manner.
- Section 704(a)(1): inspections of cosmetic manufacturing and processing facilities extend to the records described in sections 605, 606 and 610 when the applicable standard is met.
Section 610 excludes recipes and formulas, financial and pricing data, personnel data other than the qualifications of technical and professional staff, research data other than safety substantiation data, and sales data other than shipment data. The responsible person is the company named on the label as manufacturer, packer or distributor, including a foreign brand.
What FDA may ask to see
Under FDA's draft guidance, section 610 requests are most likely after recalls, adverse event reports, consumer complaints, or inspection or sampling findings. Requests can cover records kept by or for the company, in any format and at any location, such as:
- manufacturing records and ingredient and packaging receipt records;
- distribution and inventory records and customer distribution lists;
- analytical results for raw ingredients and finished products;
- complaint, adverse event, recall and safety substantiation records.
FDA's examples of other products ‘likely to be affected in a similar manner’ include products that share equipment, manufacturing conditions, ingredients, containers or closures without adequate controls, a failed critical process or a supplier of defective inputs, so one bad batch can widen the request.
Refusing access has consequences
Under the draft guidance, refusing access to section 605 records, or to records within the scope of a section 704(a)(1) inspection, including section 610 records, is a prohibited act under section 301(e) that can lead to an injunction or criminal prosecution. Section 801(a) also provides that an imported cosmetic shall be refused admission, subject to section 801(b), when FDA has credible evidence that the responsible person has not complied with section 605 or has not allowed access to its adverse event records.
How a mandatory recall unfolds
Section 611 requires FDA to find a reasonable probability that a cosmetic is adulterated or misbranded and that use of or exposure to it will cause serious adverse health consequences or death. The final guidance then describes these steps:
- FDA offers the responsible person, in writing, the chance to cease distribution and recall voluntarily.
- If that does not happen within the time and manner FDA prescribes, FDA may order distribution to stop immediately and require notice to those who manufacture, distribute, import or sell the product, and to the public.
- An informal hearing under 21 CFR part 16 must be offered, held no later than 10 days after the order.
- FDA then vacates the order, continues it until a specified date, or amends it into a recall order with notification duties, a timetable and an update schedule. Only the Commissioner can order or vacate a recall.
FDA ensures that an ordered recall is announced in a press release, and refusing or failing to follow an order is a prohibited act under section 301(iii). Evidence FDA may weigh includes inspection observations, sample results, epidemiological data, user vulnerability, serious adverse event data, complaints and whether the responsible person failed to recall voluntarily. Cosmetics that are also drugs or devices fall outside section 611.
Prepare for voluntary recalls too
FDA expects most violative cosmetics to continue to be recalled voluntarily under 21 CFR part 7, subpart C. Its general recall guidance in 21 CFR 7.59 recommends a written contingency plan, coding that allows positive lot identification, and distribution records kept beyond the product's shelf life and expected use. For a foreign brand, that means:
- a list of US products for which your company is the responsible person;
- lot-level manufacturing, raw material and test records retrievable from your factory or contract manufacturer;
- shipment records for every US importer, distributor and marketplace;
- named people who can receive an FDA notice and decide on a recall, and agreements with US partners on customer notification.
Related guidance: the general recall process is covered in how FDA recalls work for foreign manufacturers, the reporting deadline in the MoCRA serious adverse event reporting deadline, the label contact in the MoCRA label contact requirement, wider enforcement in what happens if you do not report cosmetic adverse events, the safety substantiation file in MoCRA section 608 safety substantiation and a drug-side case of an unanswered FDA records request in FDA Stories #036. FDA's final recall guidance is also summarized in what the final guidance on mandatory cosmetic recalls means for foreign brands.
How FDABridge helps
FDABridge's adverse event management keeps the section 605 records that FDA can review at inspection: intake and logging, seriousness assessment, MedWatch Form 3500A filings, follow-up filings and six-year retention. Where FDABridge is the accepted U.S. agent for a foreign cosmetic facility, it is a contact point for FDA communications relevant to that role and routes them to the facility (see the U.S. Agent service). That role is separate from the responsible person and does not itself include inspection responses or legal representation. Cosmetic facility registration, cosmetic product listing and cosmetic label review cover the facility record, listing details and the responsible person's name and address on the label.
Sources: FDA, Questions and Answers Regarding Mandatory Cosmetics Recalls, final guidance, October 2026 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-regarding-mandatory-cosmetics-recalls-guidance-industry) and 91 FR 66851 (https://www.federalregister.gov/documents/2026/10/23/2026-21679/questions-and-answers-regarding-mandatory-cosmetics-recalls-guidance-for-industry-availability); FDA, FDA Records Access Authority for Cosmetic Products, draft guidance, January 2026 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-records-access-authority-cosmetic-products) and 91 FR 2779 (https://www.federalregister.gov/documents/2026/01/22/2026-01159/fda-records-access-authority-for-cosmetics-draft-guidance-for-industry-availability); 21 U.S.C. 364 to 364i (https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapVI.htm); 21 U.S.C. 331, 374 and 381 (https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapIII.htm, https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapVII.htm, https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapVIII.htm); 21 CFR part 7, subpart C (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C); FDA, MoCRA (https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra).