Importing dietary supplements and dietary supplement components can present many challenges.  Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA).  In an effort to assure that imported food products are safe for U.S. consumers, FSMA amended the Food Drug and Cosmetic Act, to add the Foreign Supplier Verification Program (FSVP) 21 U.S.C. § 384a. FSVP requires the importers of food into the U.S. to perform risk-based supplier verification activities.  The goal of these activities is “ensuring that foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventative controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with regard to the allergen labeling.”¹ 

The Food and Drug Administration issued the final FSVP regulations in November 2015.²   In its draft guidance, released January 2018, Foreign Supplier Verification Programs for Importers of Food for Human and Animals: Guidance for Industry, FDA noted that, “the FSVP regulation applies and establishes requirements relating to:

• Use of qualified individuals to conduct FSVP activities,
• Hazard analysis,
• Food and supplier verification,
• Corrective actions,
• Recordkeeping, and
• Importer identification for a food offered for entry into the United States.” ³

The draft guidance also noted that, “(t)he general FSVP framework, together with the modified requirements applicable to certain importers and foods, are intended to be sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade.”⁴

FSVP requirements for dietary supplements and dietary supplement components differ from those of other types of foods. In addition, FSVP responsibilities differ depending on if what is imported is a dietary supplement component or a finished dietary supplement. Because FSVP relates to importing dietary supplements and dietary supplement components, the current Good Manufacturing Practice (cGMP) requirements for dietary supplements, described at 21 C.F.R. Part 111, are what U.S. importers must ensure they are verifying.  The cGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements for distribution in the U.S. Among other requirements, the DS cGMP regulations contain specification requirements that are essentially supplier verification provisions, such as:

• Proper identification of dietary supplement components;
• Specification to ensure that dietary ingredients are of appropriate purity, strength, and composition;
• Specification that ensure there is no contamination of ingredients that could lead to adulteration of the final dietary supplement; and
• Ensuring that the above are met and confirmed.

As noted, the requirements of FSVP are intended to ensure that imported food meets the same safety and quality standards of food produced in the U.S.   It can be expected that compliance with cGMPs will ensure the safety and safety of dietary supplements. Accordingly, the focus of FSVP, as it relates to dietary supplements, is on the product manufacturers’ compliance with cGMPs in their manufacturing, packaging, labeling, or holding of dietary supplements. The result is that importers of dietary ingredients and finished dietary supplements are subject to modified FSVP requirements relative to other types of food.

There are three general types of importers of dietary supplements and their components: manufacturers or processors of dietary supplements importing components for their own use; those importing components of dietary supplement for sale to dietary supplement manufacturers; and those who import finished dietary supplements.  As noted below, each of these groups must adhere to slightly different FSVP requirements.

Dietary Supplement Manufacturer/Processor Importing Dietary Supplement Components for Use in Manufacturing Dietary Supplements

For each component used in the manufacture of a dietary supplement, cGMPs requires that dietary supplement manufacturers, among other things:

• Establish specifications for the identity of each dietary supplement component;
• Conduct at least one test/examination to definitively confirm the identify the component;
• Establish specifications for each dietary supplement component, sufficient to ensure the purity, strength, and composition of the final dietary supplement as it is reflected in the Master Manufacturing Record;
• Establish specification for each dietary supplement component, which include limits on contamination that could adulterate the final dietary supplement;
• Confirm the specifications for each dietary supplement component; and
• Establish specifications for labels and packaging that come in contact with the dietary supplement (or dietary supplement component) and could affect the safety of the finished dietary supplement.

In short, if an importer of dietary supplement components is a dietary supplement manufacturer/processor, and is complying with cGMPs, that importer has met its main FSVP obligations.⁵   This type of importer of dietary supplement components is not required to comply with the other FSVP requirements, such as the hazard analysis or evaluation of foreign suppliers and verification activities. However, they must be identified as the FSVP importer on the U.S. Customs and Border Protection entry filings, use a preventative controls qualified individual, and maintain records under the cGMPs.⁶

Dietary Supplement Component Distributor Importing Dietary Supplement Ingredients for Sale to Dietary Supplement Manufacturers

If one is an importer of dietary supplement components, and the customer is required to establish specifications for those components, and the customer is in compliance with the requirements of cGMPs, one must:

• Comply with the FSVP requirements for using qualified individuals and qualified auditors;
• Identify the FSVP importer at the time of entry;
• Comply with the FSVP records requirements; and
• Obtain an annual written assurance from the customer that they are in compliance with those requirements.⁷

However, one is not required to comply with the other FSVP requirements.⁸

Importer of Finished Dietary Supplements

Importers of finished dietary supplements do not need to set specifications for dietary supplement components or packaging under 21 C.F.R. Part 111.⁹    Such importers are not required to conduct a hazard analysis under FSVP. However, they must follow some FSVP requirements, such as:

• Using a qualified individual to develop the FSVP;
• Evaluating foreign supplier performance, including approving the foreign supplier;
• Conducting appropriate supplier verification activities, including the use of approved suppliers;
• Establishing and then taking corrective actions as appropriate;
• Identifying the FSVP importer at the time of entry; and
• Documenting and maintaining records required under FSVP.¹⁰

Importers of finished dietary supplements can conduct their own supplier verification activities or rely on supplier verification activities conducted by another competent entity. If another competent entity is responsible for verification activates, the dietary supplement importer must review, assess and document the results of their activities.  With the exception of the sampling and testing of the finished dietary supplements, the foreign supplier of the dietary supplement being imported cannot conduct their own verification of FSVP supplier activities.

The FSVP required foreign supplier verification activities for imported finished dietary supplements must ensure that the foreign supplier is ensuring that the dietary supplement being imported into the U.S. satisfies cGMP requirements.

In summary:

• Under FSVP, the U.S. importer of dietary supplements and their components has the responsibility to ensure that its foreign suppliers are manufacturing products for import that meet the same food safety standards that are required of such commodities when produced in the U.S.
• As FSVP relates to importing dietary supplements and dietary supplement components, compliance with the cGMPs for dietary supplements is critical.
• FSVP requirements for dietary supplements and dietary supplement components differ from those of other types of foods and differ from each other depending on if one imports DS components or finished dietary supplements.

[1] https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp

[2] The FSVP regulations are described at 21 C.F.R. § 1.500 through § 1.514.

[3] Food and Drug Administration, Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Human and Animals: Guidance for Industry (Jan, 2018), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals

[4] Id.

[5] Note that, under FSVP, packaging and labeling are considered processing.

[6] A preventive controls qualified individual, is an individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

[7] See 21 CFR § 1.510.

[8] See 21 CFR § 1.511(b).

[9] See 21 CFR § 111.70(b) and (d).

[10] See 21 CFR §§ 1.503, 1.505, and 1.508 through 1.510.