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Owners operators or agents in charge of domestic or foreign facilities that manufacture process pack or hold food for consumption in the u.
Fda dietary supplement establishment registration. Application form for the registration of a food dietary nutritional supplement to be submitted in duplicate cover letter addressed to. The dietary ingredients in these products may include. This page contains links with information on how to register a food facility.
Companies located outside the united states must designate a u s. Us fda food dietary supplement regulation. As part of the provisions of the bioterrorism act of 2002 food facilities are required to register with fda.
The chief executive food and drugs authority p o box ct 2783 cantonments accra ghana. Fda registration is required for all facilities that manufacture process pack or store dietary supplements that may be consumed in the united states by humans or animals. Drug establishments current registration site.
To contact the office of dietary supplement programs email. Agent for fda communications. All food establishments domestic and foreign that manufactures processes packs or holds food for consumption by humans or animals in the u s must register their company with the fda.
Vitamins minerals herbs or other botanicals amino acids and substances such as enzymes organ tissues glandulars and metabolites. Registration renewals with the fda must be completed every other year between october 1 to. Manufacturers of dietary supplments or nutrient supplements require fda food facility registration nutrient dietary supplements are substances which are necessary for the body s nutritional and metabolic processes.
Fda registration dietary supplements. The fda food safety modernization act fsma enacted on january 4 2011 amended section 415 of the federal food drug and cosmetic act fd c act in relevant part to require that facilities. A dietary supplement is a product taken by mouth that contains a dietary ingredient intended to supplement the diet.
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