FDA final guidance on FSVP programs: Human & Animal Food Importers

FDA final guidance on FSVP programs: Human & Animal Food Importers

FDA Final Guidance on FSVP programs for Importers of human & animal food



The U.S. Food and Drug Administration recently released its  final guidance on Foreign Supplier Verification Programs (FSVP) for importers of food for humans and animals. The document contained several Q&As to help the industry comprehend FSVP requirements.  You can click above to see the full document of questions and answers, but we’ll provide a summary of the top information in this article.

What are the FSVP Importer Requirements?

FDA was clearer in the requirement that if someone does not meet the definition of U.S. owner, they cannot take that responsibility on behalf of someone else. The only case where someone else can take that responsibility without being the owner is if there is no U.S. owner, and they are acting on behalf of the foreign entity to conduct FSVP.” 

How do I have to maintain my FSVP records?

You must keep records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records to support your FSVP for each food from a particular foreign supplier (21 CFR 1.510(a)(1)).  You must sign and date your FSVP records upon initial completion and upon any modification of the FSVP (21 CFR 1.510(a)(2)).

What can food Importers do when they are incorrectly listed as an FSVP Importer? 

FDA frequently inspects importers and asks for FSVPs for foods that the company has never imported. Companies can let the FDA know when they have been incorrectly identified as FSVP importers by making a request under the Freedom of Information Act. To make sure you aren’t listed for foods that you aren’t the U.S. owner of the FDA advises that you contact the customs broker mentioned in the line entry and find out who filed the wrong information.

Sometimes businesses misunderstand the function of a U.S. Agent, resulting in inaccurate FSVP importer identifications. Businesses might believe that a U.S. Agent under the Bioterrorism Act has the same function as a U.S. Agent under the FSVP. They have different requirements and responsibilities. A U.S. Agent is someone in the U.S. who can act as a link between the FDA and a foreign facility or vice versa to ensure communication is effective between them. It’s not specific to FSVP. A U.S. Agent for FSVP purposes is representing the foreign owner and taking responsibility for the safety of the food imported. This U.S. Agent must agree in a signed statement of consent to act as the U.S. Agent to be considered as the party responsible for FSVP by FDA.

Does FSVP affect restaurants?

Although not all restaurant locations are required to store FSVP information, the guideline emphasises that restaurants are susceptible to FSVP. If someone is a U.S. owner and they are not a customer, they are subject to the FSVP obligation.  FSVP is the responsibility of the owner at the time of U.S. entry. However, if you have several importing offices or facilities, you can maintain FSVP documents at one headquarters site provided you have records identifying the individuals in charge of FSVP for each of the many importing locations.

Are CGMPs Applicable to Animal Dietary Supplements?

FDA revised its advice on dietary supplements for animals to make it clearer which laws apply. Current Good Manufacturing Practices (CGMPs) for dietary supplements are applicable to supplements meant for human consumption. Animal dietary supplements are not subject to a separate set of rules, according to FDA. The advice makes it clear that regular PC requirements apply instead of the enhanced requirements under FSVP if your supplement is advertised for use by animals.

Is animal food governed by FSVP or HACCP?

Companies frequently believe that simply because a product is seafood, HACCP requirements apply to it immediately. If the food is intended for animals, this isn’t the case.

Fish and fisheries products meant for animal food are subject to FSVP, according to FDA.  HACCP applies to seafood meant for human consumption, but Preventive Controls (PC) for Animal Food apply to food designed for consumption by animals. The same holds true for meat and poultry items made for animals. Regulations under PC for Animal Food, not USDA, apply to these goods.

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When Is a Hazard Control Needed?

The FDA guidance specifies more clearly that, “if you determine there’s a known or foreseeably reasonable hazard that could result in serious health consequences or death to human or animals, FDA expects there to be a control assigned to that hazard. It depends on your assessment and what measures would control that hazard, but typically if there’s a hazard, there needs to be a control somewhere in the supply-chain associated with it.”

For Dietary Supplements Ingredients what role does an FSVP play?

According to FDA if you’re importing an ingredient for a dietary supplement, it will have the PC rule applied to it since it’s a dietary ingredient in it’s present form.  The following regulations are applied when a company imports dietary ingredients depending on what will be done with the ingredients:

  • Dietary supplement manufacturers importing dietary ingredients: Importers manufacturing supplements must identify themselves as the FSVP importer for these ingredients but do not need FSVPs for the ingredients. Instead, these manufacturers are subject to dietary supplement CGMPs which already have strict requirements regarding the components used to manufacture a dietary supplement. 
  • Importers of ingredients that are not manufacturing dietary supplements: When importers are distributing ingredients to another entity, they must have a standard FSVP for each imported ingredient.

What do I have to do to verify my Dietary Supplements?

Verification procedures for finished dietary supplements used to be unclear. How may importers of finished dietary supplements discover appropriate verification activities without one since their updated FSVPs don’t call for hazard analyses?  To confirm that the supplier has established the essential requirements as specified in an MMR (Master Manufacturing Record) and that the dietary supplement complies with them, further sorts of verifications must be made.

An MMR is necessary for every batch of dietary supplement prepared. If suppliers are producing vitamins and minerals in various concentrations, formulations, or sizes, they must have a document outlining all the steps they will take to ensure the supplement is what they intend it to be, including providing a control, conducting testing, and specifying the supplement’s ingredients.

The importer should assess those controls and confirm that they are adequate and that the supplement complies with standards if the foreign supplier has created those controls and the tests they are using to guarantee the specifications are fulfilled.  Manufacturers are required to have written quality control procedures in addition to MMRs.

For more information about FSVP Regulatory Assessment Record Keeping click here:

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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