In July the FDA proposed two rules under the Food Safety Modernization Act (FSMA). One rule concerns Foreign Supplier Verification Programs (FSVP). The other concerns Accreditation of Third Party Auditors. Under the FSVP rule, FDA plans to have importers verify that their suppliers meet the same U.S. safety standards required of domestic food producers. The proposed rule for Accreditation of Third Party Auditors sets criteria under which FDA will recognize accrediting bodies. Those accreditation bodies would accredit third party auditors to audit and issue certifications for foreign food facilities. Here we discuss the proposed FSVP rule.
In sum, the proposed FVSP rule requires importers to review the compliance status of food and foreign suppliers before importing. Importers must analyze hazards associated with each food they import, and verify that those hazards are adequately controlled. FDA would also require documentation of corrective activities for consumer complaints, which may require an investigation of responsible foreign suppliers. The rule also includes record-keeping obligations.
FDA included several exemptions or modified requirements that are described in the FDA’s proposed rule. See 78 Fed. Reg. 45732-45738 (July 29, 2013). Of particular significance, the FDA relaxed the FSVP obligations for dietary supplement companies that already comply with the dietary supplement cGMPs in 21 CFR Part 111. Nonetheless, dietary supplement importers might still be required to comply with certain provisions, including, for instance: § 1.506(a) (listing of foreign suppliers); § 1.509 (identification of the importer at entry); 1.510 (records); and § 1.511(c) (supplier verification). The supplier verification procedures in Section 1.511(c) are intended to ensure compliance with the dietary supplement cGMPs. Those requirements could add substantial compliance costs for importers of finished dietary supplements. For example, “[f]or each dietary supplement imported, the importer must conduct one or more of the verification activities listed in proposed § 1.511(c)(5(i) through (c)(5)(iv) before using or distributing the dietary supplement and periodically thereafter.” See 78 Fed. Reg. at 45764-65. That might include periodic onsite auditing, periodic or lot-by-lot sampling and testing, periodic review of the supplier’s food safety records, and any other procedure appropriate. In short, the FDA expects dietary supplement importers will verify that their foreign suppliers conform to the cGMPs in 21 CFR Part 111.
For importers of conventional foods, the FDA’s FSVP proposal would create broad obligations to ensure that foreign suppliers are manufacturing food products in conformance with domestic law. Failure to comply with the regulations proposed in 21CFR §§ 1.500-1.513 would result in refusal of admission for an imported article, and non-compliance will be deemed a prohibited act under the FDCA. See 21 CFR 1.514(b) (proposed); 21 U.S.C. § 331(zz) (proposed).
Comments on the proposed FSVP rule are due November 26, 2013 and can be filed through www.regulations.gov, Docket No. 2011-N-0143-0023.
