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.
Under the FSVP proposal, importers would need to establish the following:
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.
Additionally, modified FSVP requirements apply in certain situations, such as for the importation of dietary supplements.
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.