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FDA's Supplier Verification Rule Modified for Supplements

WASHINGTON—Supplement manufacturers whose foreign suppliers follow GMPs (good manufacturing practices) get a break under a new FDA proposed rule on food supplier verifications. However, if foreign suppliers don't comply to GMPs, supplement companies must incorporate additional risk control measures.

Designed to strengthen the oversight of foods imported for U.S. consumers,  the proposed rule for Foreign Supplier Verification Programs (FSVP, Docket Number: FDA-2011-N-0143), requires food importers, including supplement manufacturers, to  evaluate certain risk-based activities to confirm imported foreign food is as safe as food produced domestically.

For dietary supplements, if the foreign material supplier complies with supplement GMPs, U.S. manufacturers don't need to take extra steps beyond the GMPs they already follow. According to the proposed rule, these companies need to keep a written list of foreign suppliers, conduct importer identification using a Dun and Bradstreet Data Universal Numbering System (DUNS) and keep records.

However, supplement companies with importers that do not follow GMPs need to add several steps to be in compliance with the proposed FSVP rule, including:

  • Compliance status review, including research on FDA warning letters, import alerts and certification requirements;
  • Hazard analysis that identifies hazards that are reasonably likely to occur for each type of food imported;
  • Verification that hazard risk is controlled;
  • Review and correct product complaints;
  • Periodic reassessment of the FSVP;
  • Importer identification; and
  • Recordkeeping.

Supplement companies are regulated under modified requirements of the FSVP rule. The FSVP proposed regulations for all imported foreign foods vary based on the type of food product (such as processed foods, produce and dietary supplements), the category of importer, the nature of the hazard in the food, and who control the hazard (either the importer or the supplier).

FDA said compliance dates would vary depending on circumstances, but in general, the compliance date would be 18 months after the publication date of the final FSVP regulations.

FDA estimated the proposed rule will cost the food industry between $480 million to $492 million for the first year of implementation, and $462 million to $473 million each year after that.

FDA is accepting comments on the proposed rule for 120 days after the proposed rule “Food Supplier Verification Programs for Importers of Food for Humans and Animals," is published in the Federal Register on July 29, 2013.

FDA also said it will publish a draft guidance to assist importers in developing and following FSVPs when it publishes the final rule on FSVPs.

The FSVP regulations are a part of the FDA Food Safety Modernization Act (FSMA), which was signed into law on Jan. 4, 2011.

FDA proposed the FSVP rule along with another proposed rule on the accreditation of third-party auditors, which has to do with food audits that would be conducted under the food GMPs (good manufacturing practices), Part 110, which are separate from supplement GMPs.

While FSMA remains largely focused on conventional foods, it is good news for the dietary supplement industry, according to an INSIDER article written by Mike Greene, vice president, government relations, the Council for Responsible Nutrition (CRN).

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