Dietary supplement are taken orally and generally incorporate vitamins & minerals, amino acids, enzymes, herbs etc. in the form of gels, capsules, powder & tablets. Until October 1994, dietary supplements had same requirements as the regular foods. However the Dietary Supplement Health and Education Act (DSHEA) were signed into law in October 1994. Producers and suppliers of dietary supplements cannot market them in U.S.
if they are either adulterated or misbranded. Hence they must assess the safety as well as labeling of what they market to make certain that they confirm every guideline of DSHEA and FDA regulations. It is mandatory for the manufacturer or marketer of the dietary supplement whose name is printed on the label to submit to FDA completely, the serious adversative factor reports related with usage of the dietary supplement.
In addition to regulatory compliance, our US FDA Registration Service for Dietary Supplements provides complete assistance with facility registration, product listing, and label review to ensure adherence to FDA guidelines. We also support clients in implementing Good Manufacturing Practices (GMP), maintaining proper documentation, and preparing adverse event reporting systems. With our expert guidance, businesses can confidently enter the U.S. market while ensuring product safety, transparency, and long-term regulatory compliance.
US FDA registration for dietary supplements is the process of registering food/dietary supplement manufacturing facilities and complying with FDA regulations (NDI notification, cGMP, and labeling) before selling supplements in the USA.
The FDA does not "approve" dietary supplements before they are marketed; however, facilities must be registered, and products must comply with cGMP, safety, and labeling regulations.
An NDI notification is required if a dietary supplement contains a new ingredient that was not marketed in the U.S. before October 15, 1994, demonstrating ingredient safety prior to marketing.
Facility registration details, DUNS number, product labeling information, ingredient lists, manufacturing process documentation, and cGMP compliance records.
Yes, foreign manufacturers and facility owners exporting dietary supplements to the U.S. must designate a U.S. Agent for FDA communications.
Facility registration can usually be completed in a few business days once all facility details and U.S. Agent confirmation are provided.
Supplement labels must include a Supplement Facts panel, statement of identity, net quantity, ingredient list, manufacturer details, and appropriate disclaimer statements.