Does FDA Approve Dietary Supplements (Nutraceuticals)?
FDA does not approve dietary supplements. FDA only approves new drugs and biologics. Dietary supplements (nutraceuticals) are not reviewed and approved by FDA instead FDA issues regulations about ingredients, labeling, registration, etc. and it is industry's responsibility to comply with these regulations.
What Regulations must Dietary Supplements comply with?
FDA requires that the labeling of all dietary supplements contain specific information including (1) net contents; (2) statement of identity; (3) Supplement Facts panel; (4) name and address of the manufacturer or distributor; (5) directions for use; and (6) where necessary Other Ingredients. Customs and Border Patrol requires that products, including dietary supplements, comply with country of origin markings.
FDA also requires that the ingredients in a dietary supplement be permitted for use in the dietary supplement either through an exemption or through a new dietary ingredient application.
Dietary supplement companies are considered food facilities and may require FDA registration under the Bioterrorism Act, as well.
Any structure/function claim on the labeling of a dietary supplement must be reported to FDA within 30 days of introducing the dietary supplement to market. What is considered labeling versus marketing material is addressed through various court cases. Each circumstance is different, but it has been ruled that if a marketing material accompanies the product, even if it is not attached to the product, that marketing material may be considered labeling and thus subject to FDA jurisdiction.