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Jun 30

FSVP: Basics for Importers of Dietary Supplements and Their Components – JD Supra

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The Food and Drug Administration issued the final FSVP regulations in November 2015.2 In its draft guidance, released January 2018, Foreign Supplier Verification Programs for Importers of Food for Human and Animals: Guidance for Industry, FDA noted that, the FSVP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

The draft guidance also noted that, (t)he general FSVP framework, together with the modified requirements applicable to certain importers and foods, are intended to be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:

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.

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

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

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:

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

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:

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:

[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.

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FSVP: Basics for Importers of Dietary Supplements and Their Components - JD Supra

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