MoCRA expands US FDA authority to access cosmetics records tied to safety risks
Key takeaways
- The FDA issued draft guidance clarifying when it may access cosmetics companies’ records under the MoCRA law.
- The agency can review adverse event documents during inspections and has the authority to request more in certain cases.
- The FDA says it cannot access certain records, including formulas, most research data, and most financial or personnel records.
The US Food and Drug Administration’s (FDA) oversight capabilities for cosmetic products have expanded. The agency has issued a draft guidance on its authority to access companies’ cosmetics records. The draft explains when the FDA can request and copy company documents about cosmetic products, specifically in cases of adverse events and safety threats.
When the agency believes a product may have been contaminated or could cause serious harm or death, it may copy and access records related to the product’s manufacturing, distribution, testing, safety, and compliance.
However, even under the same belief, there are certain documents the FDA may not demand, such as financial reports and personnel records.
“These new authorities represent a significant expansion of the FDA’s oversight capabilities for cosmetic products, providing the agency with enhanced tools to protect public health and safety,” the administration says.
Its authority comes from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which was signed into federal law in late 2022. The agency has opened a commenting period, after which the guidance will be finalized.
Adverse event access
The document highlights how the FDA will use its authority to access company records, as granted through the MoCRA. According to the group, its extended access to these records was codified in the Federal Food, Drug, and Cosmetic Act under sections 605 and 610.
Under section 605, the FDA may access company records regarding adverse event notifications during an inspection. This includes the back-and-forth communication between the company and whoever reported the reaction, including the initial outreach and how the company responded..webp)
The FDA may access safety substantiation documents from companies if it has reason to believe a product could cause health risks.
The government agency can now gain access to the entire report file, rather than just what the company responsible chooses to disclose to the FDA.
Copy rights
The draft also explains when the FDA can request a wider set of records under section 610. According to the draft guides, the FDA may access and copy certain company records if it has a reasonable belief that a cosmetic product, or an ingredient in the formula, could pose a threat of serious adverse health consequences or death (SAHCOD).
The access includes records about its manufacture, testing, storage, and distribution.
The guidance adds that the FDA is most likely to use its authority in SAHCOD scenarios when it receives reports of recalls, adverse events, or consumer complaints. It can also use its authority to request these documents if an agency inspection points to safety risks.
The agency notes, however, that its authority under section 610 is limited. The draft guidance lists various records that the agency may not access, including formulas and recipes, financial and pricing data, and personnel records. The FDA will also not be able to access most of an ingredient or product’s research data outside of its safety substantiation.
The guidance also says companies must keep their original adverse event records, or true copies thereof, for six years. According to the FDA, it will protect confidential company information in accordance with existing US laws.
If a company refuses to provide the records the FDA requests, it could trigger enforcement actions such as civil or criminal penalties.
