With an ever-increasing amount of food we eat coming from other countries, it has become a challenge to assure that imported food meets the same safety standards as food grown and produced in the U.S. On Jul. 26, 2013 the U.S. FDA issued two proposed regulations aimed at addressing this challenge.  

The first proposed rule establishes requirements for importers in implementing a Foreign Supplier Verification Program (FSVP). The second proposed rule would establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. FDA will use certifications issued by accredited third-party auditors for both its Voluntary Qualified Importer Program (VQIP) and FSVP. Although the FSVP proposal does not require the use of accredited third-party auditors, FDA anticipates that once the accreditation system is in place, importers may increasingly rely on audits by accredited third parties to meet their supplier verification requirements under FSVP.

FDA’s proposed FSVP rule, if ultimately adopted, would require importers to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur, and require importers to provide adequate assurances that these hazards are being adequately controlled. However, the agency has proposed a “modified approach” for the importation of dietary supplements that echoes Section 418 of the Federal Food, Drug, and Cosmetic Act (FDCA), which otherwise exempts dietary supplement manufacturing facilities from many hazard analysis requirements. In short, FDA is proposing “FSVP requirements for dietary supplements and dietary supplement components that reflect the food safety regulations applicable to those products (i.e., dietary supplement current good manufacturing practices, or cGMPs) rather than the general approach of verifying the hazards identified as reasonably likely to occur are being adequately controlled.”

The Food Safety Modernization Act (FSMA) provides that foreign supplier verification requirements were to become effective in January 2013; however, FDA has announced its intention not to enforce these provisions until after it issues a final rule and establishes effective dates for those requirements. Thus, enforcement of these requirements is a year or more away. Nevertheless, companies should begin contemplating how they will meet these requirements, if they have not done so already.

FSVP Requirements
Under the FSVP proposal, importers would need to establish the following:

• Compliance Status Review: Importers are required to review FDA Warning Letters, import alerts, etc. concerning the food and potential foreign supplier before importing the food (and conduct these reviews periodically thereafter).

• Hazard Analysis: This analysis would identify the hazards reasonably likely to occur, and evaluate the consequences if such a hazard were to occur.

• Verification Activities: Importers must provide adequate assurances the hazards identified are adequately controlled. FDA is proposing two options for implementing verification procedures, although each potentially involves activities such as onsite auditing of foreign suppliers, sampling and testing of the food and/or review of the supplier’s food safety records.

• Corrective Actions: Importers must review and investigate complaints concerning the foods they import, and take corrective action when appropriate.

• FSVP Reassessment: Importers must reassess their FSVPs every three years.

• Importer Identification: Importers must obtain and use a Dun & Bradstreet Data Universal Numbering System (DUNS) number to file with U.S. Customs.

The proposed FSVP requirements vary based on a variety of factors, including the type of food product (e.g., processed foods, produce and dietary supplements), the category of importer, the nature of the hazard in the food and who is to control the hazard. For example, certain foods are exempt from FSVP procedures, such as food imported for research or evaluation purposes and food imported for further processing and export.

Additionally, modified FSVP requirements apply in certain situations, such as for the importation of dietary supplements. However, the modified requirements would differ depending on whether the importer is bringing in: a) dietary supplement components or dietary supplements that will be subject to further processing (Unfinished Dietary Supplements) or b) Finished Dietary Supplements. According to the rule, “further processing” includes additional packaging and/or labeling.  

An importer of Unfinished Dietary Supplements is exempt from most of the generally applicable FSVP requirements only if the foreign facility is in compliance with the dietary supplement cGMP requirements established in Title 21, Part 111 of the Code of Federal Regulations. An importer must verify this compliance, and the agency can refuse admittance based on non-compliance with the cGMPs in Part 111. The refusal would be based on 1) adulteration and 2) violation of the FSVP rule. The importer would then be faced with a tough decision: become compliant with Part 111 or create and institute an FSVP.

Importers of Unfinished Dietary Supplements, if fully compliant with cGMPs, are exempt from the FSVP requirements regarding review of food and supplier compliance status, hazard analysis, supplier verification (except for listing of suppliers), investigative and corrective actions and FSVP reassessment. However, the proposed rule does require such importers to comply with the FSVP requirements for listing foreign suppliers, identifying the importer at entry and record keeping.  

Unlike importers of Unfinished Dietary Supplements, Finished Dietary Supplement importers would still be required to comply with most of the standard FSVP requirements under the proposed rule. However, these obligations would be modified. A key modification is that an importer of Finished Dietary Supplements would not have to evaluate the hazards reasonably likely to occur. FDA justified this modification with its belief that “the dietary supplement cGMP regulations effectively address the control of relevant hazards by including provisions encompassing all aspects of dietary supplement production.” An additional significant modification is that their supplier verification activities would focus on confirming that the supplier is in compliance with the dietary supplement cGMP regulations, rather than verifying that hazards identified as reasonably likely to occur are being adequately controlled.
Comments on the proposed rule are due by Nov. 26, 2013.