FDA Guidance and Training Programs

In December, CFSAN published a number of documents related to its ongoing FDA Food Safety Modernization Act (FSMA) implementation process. On December 14, 2016, CFSAN published a final rule establishing user fees for its voluntary third-party certification program for food safety audits of foreign food facilities.

On December 6, 2016, CFSAN issued a final guidance setting forth model standards to be used by recognized accreditation bodies to qualify third-party certification bodies. Both documents are important steps in FDA’s rollout of the third-party certification program.

In addition, on December 21, 2016, CFSAN published an updated training strategy for FSMA, which includes grants to facilitate training and encompasses public-private alliances that provide education on FSMA requirements. In late December, FDA also issued a revised draft Q&A guidance regarding food facility registration. CFSAN describes its FSMA strategy as “evolving” and we can expect additional updates as remaining FSMA rules are fully implemented.

Adverse Event Report Data for Foods and Cosmetics

In early December 2016, CFSAN announced that it will begin posting on its website, on a quarterly basis, adverse event data for food (including dietary supplements, food additives and color additives) and cosmetics that CFSAN has received through its CFSAN Adverse Event Reporting System (CAERS).

CFSAN receives adverse event reports through CAERS from consumers, health care providers and manufacturers. Previously, CAERS data was typically only made publicly available through a Freedom of Information Act (FOIA) request.

CFSAN intends these posts to yield more thorough adverse event reporting that in turn will enable CFSAN to identify potential product safety issues more quickly. However, the utility and effect of the posts remains to be seen, particularly for those industries where reporting is not mandatory. And there is no doubt that product liability law firms will be watching these voluntary and mandatory report disclosures carefully, despite the fact that the reports are not evidence of causation.