Dietary Supplements

Supplement Facility Registration

U.S. regulations require all food and dietary supplement facilities (e.g., that manufacture, process, pack, or hold food, beverages…

Food/Supplement Facility Registration

U.S. regulations require all food and dietary supplement facilities (e.g., that manufacture, process, pack, or hold food, beverages, or dietary supplements for consumption in the U.S.) to register with FDA and food facilities located outside the United States must designate a U.S. Agent.

Food and dietary supplement facility registration is mandated by the Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”) express in regulations at 21 C.F.R. § 1, Subpart H.

Renewals The registration must be renewed every even numbered year between October 1 and December 31. Definitions

“Manufacturing/processing” means: means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.

“Packing” means: means placing food into a container that directly contacts the food and that the consumer receives.

“Holding” means: means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)).

Exempt Operations

Foreign facilities when food undergoes further processing at a subsequent facility outside the US.
Farms (not including a farm that sends processed product other than raw products out into the market)
Retail Establishments
Restaurants
Nonprofits serving directly to consumers
Fishing vessels
Meat, poultry, and egg processing facilities regulated by USDA throughout the whole facility.

Dietary Supplements

Supplement Facility Registration​

Food/Supplement Facility Registration

Dietary Supplement Label Review

Label & Claims Review

FSVP for Dietary Supplements

FSVP (limited)

Dietary Supplement GMPs

Dietary Supplement Good Manufacturing Practices (GMPs)​

Serious Adverse Events Compliance

Serious Adverse Events Compliance

Structure/Function Notification

Structure/Function Notification

USDA Permits

USDA Permits

Prior Notice

Prior Notice

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Supplement Facility Registration

Dietary Supplement Good Manufacturing Practices (GMPs)