Dietary Supplements (Nutraceuticals) FDA Approval

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.

Awards

Lisa capote pr av 300

10.0Lisa Capote

Awards

Our attorneys are AV rated since 2012 and bilingual. The firm has been recognized as International Trade Law Firm of the Year in Florida by Global Law Experts and Best FDA Compliance Law Firm - Florida by US Business News. Our attorneys have a 10 out of 10 Rating with Avvo.

Copyright © 2018 Capote Law Firm

This website is intended solely to convey general information about Capote Law Firm and should not be construed as legal advice. Neither your use of this site nor your transmission of electronic mail to Capote Law Firm or any of its lawyers will create an attorney-client relationship. The formation of an attorney-client relationship requires satisfaction of multiple factors such as resolution of possible conflicts of interest, an appropriate fee arrangement, and mutual agreement on the terms of the engagement. This Website should not be interpreted as an offer by Capote Law Firm or any of its attorneys to practice law in any jurisdiction in which Capote Law Firm or the attorneys are not properly authorized to do so. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience or call us to discuss any specific questions.

Menu