In January 2023, the U.S. Food and Drug Administration (FDA) released its final guidance on Foreign Supplier Verification Programs (FSVP) for importers of food for humans and animals. The guidance added questions and answers to help the industry understand FSVP requirements.  

Fabiola Negrón, Registrar Corp’s Food Safety Department Manager, has over 10 years of food safety experience and has helped numerous companies comply with FDA’s FSVP regulations. We asked her to walk us through some of the guidance’s most significant inclusions. 

What are FDA’s FSVP Importer Requirements? 

Registrar Corp’s customers often believe they can pay another party to implement their FSVPs.  

“FDA added more questions and were clearer on who can implement an FSVP, or who is subject to FSVP,” Negrón explains. “FDA was clear 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.” 

 Are Restaurants Subject to FSVP?  

The guidance specifies that restaurants are subject to FSVP, but not every restaurant location needs to store FSVP records. “As long as somebody meets the definition of a U.S. owner, and they are not a consumer, they’re subject to the FSVP requirement,” Negrón said. “Whoever is the owner at the time of U.S. entry is responsible for FSVP. However, if you have multiple importing offices or facilities, you can keep FSVP documents at one headquarters location as long as you have documentation that identifies who is responsible for FSVP for all the different importing locations.    

What Can Importers Do When Incorrectly Listed as an FSVP Importer? 

Oftentimes, FDA will inspect an importer and request FSVPs for foods the company never imported. Companies can identify when they’ve been wrongfully listed as an FSVP importer through submitting a request to FDA through the Freedom of Information Act. “FDA provides guidance that you may contact the customs broker identified in the line entry and learn who entered the incorrect information to make sure you’re not being listed for foods that you’re not the U.S. owner of,” explains Negrón.   

Sometimes incorrect FSVP importer identifications occur when companies misinterpret the role of a U.S. Agent. Companies may assume that a U.S. Agent under the Bioterrorism Act serves the same purpose as a U.S. Agent under FSVP. “They’re 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.”  

Negrón adds that problems can also arise when foods are inadequately identified at entry. 

“It’s important that, in addition to identifying the correct FSVP importer, companies use the correct product codes when submitting product information on their Prior Notice submission and to customs. It’s critical that all the information throughout the process is accurate.”  

For instance, if you import a juice and declare it as a beverage, FDA will consider the product a beverage subject to FSVP regulations. However, unlike other beverages, juice is subject to importer requirements under the Hazard Analysis Critical Control Points (HACCP) regulations, not FSVP.  

Is Animal Food Subject to HACCP or FSVP?  

Companies often think that because a product is seafood, it’s automatically subject to HACCP regulations. This isn’t the case if the food is intended for animals.  

“FDA made clear that fish and fishery products intended for animal food are subject to FSVP,” Negrón said. Seafood intended for human consumption falls under HACCP, but animal food is subject to the Preventive Controls (PC) for Animal Food. The same applies to meat and poultry products intended for animals. These products are subject to PC for Animal Food, not USDA regulations.  

When Is a Hazard Control Needed? 

Negrón says the 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.”  

Are Dietary Supplements for Animals Subject to CGMPs?  

FDA reworded guidance regarding dietary supplements for animals to clarify which regulations apply. “Dietary supplement Current Good Manufacturing Practices (CGMPs) apply to supplements intended for human consumption. FDA does not recognize a separate regulation for supplements for animals. They would be under the Preventive Controls (PC) for Animal Food,” Negrón said.  The guidance clarifies that if your supplement is marketed for animals it’s not subject to the modified requirements under FSVP, rather it’s subject to standard PC requirements.  

Do I Need an FSVP for Dietary Supplements Ingredients?  

“FDA is clearer that if you’re importing an ingredient for a dietary supplement, it’s still going to fall under the PC rule, because it’s not a dietary supplement yet, it is a dietary ingredient.”  

When a company imports dietary ingredients, the applicable regulations depend on what the importer is doing with the ingredients: 

• 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. 
• 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. 

What Verification Activities are Required for Dietary Supplements?  

Previously, there was confusion surrounding verification activities for finished dietary supplements. Because importers of finished dietary supplements have modified FSVPs that don’t require a hazard analysis, how can they identify appropriate verification activities without one?  

Negrón explains, “You must conduct other types of verifications to ensure that the supplier has established the necessary specifications as required in an MMR (Master Manufacturing Record) and the dietary supplement meets them.”  

Each batch of dietary supplement produced requires an MMR. “If suppliers are producing vitamins and minerals with different concentrations, formulations, or sizes, they must have a document that lists all the steps in which they’re going to provide a control, conduct testing, or have specifications that ensure the supplement is what they intend it to be. If the foreign supplier has established those controls and the tests they’re conducting ensure the specifications are met, the importer should evaluate those and confirm they’re adequate and that the supplement meets the specifications.” 

In addition to MMRs, manufacturers also must have written procedures for quality control operations. 

About Our Expert:  

Fabiola Negrón holds a Bachelor of Science in Industrial Microbiology and completed graduate coursework in Food Science and Technology at the University of Puerto Rico. Her 10+ years of expertise includes food safety training in Good Manufacturing Practice, Preventive Controls for Human Foods, HACCP for Seafood and Juice, Foreign Supplier Verification Program, and others.  Negrón oversees Registrar Corp’s team of Regulatory Specialists that assist domestic and foreign food facilities and U.S. importers with U.S. FDA food safety compliance.  Her team helps companies develop Food Safety Plans, HACCP Plans, FSVP Plans, Food Defense Plans, and have served as FSVP Agents as well as offering FSVP implementation services.