Do you need FDA approval to sell vitamins?
Most vitamin products marketed as dietary supplements in the United States do not require FDA premarket approval before sale. However, manufacturers and distributors must comply with applicable dietary-supplement requirements, including safety responsibilities, labeling rules, Current Good Manufacturing Practices, facility registration requirements, and certain premarket notifications when a New Dietary Ingredient is involved.
Answer
The FDA generally does not approve dietary supplements before they are marketed in the United States.
Therefore, a conventional vitamin product sold as a dietary supplement does not normally go through the premarket approval process required for a new pharmaceutical drug. This does not mean vitamin supplements are unregulated.
Companies marketing vitamins as dietary supplements remain responsible for compliance with requirements including:
• Product safety
The company is responsible for ensuring that the supplement is not adulterated and can be lawfully marketed.
• Dietary-supplement CGMPs
Manufacturers, packers, labelers, and holders of dietary supplements must comply with applicable Current Good Manufacturing Practice requirements.
• Labeling
The Supplement Facts panel, ingredient declaration, identity statement, claims, warnings, and other labeling elements must meet applicable requirements.
• Food-facility registration
Facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States may be required to register with FDA.
• New Dietary Ingredient notifications
A supplement containing certain New Dietary Ingredients may require a safety notification to FDA at least 75 days before introduction into interstate commerce.
Importantly, an NDI notification is not the same as FDA approval of the finished supplement.
Requirements can also differ if a vitamin product is marketed as a conventional food or as a drug rather than as a dietary supplement.
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