Regulatory Authority for Dietary Supplements in the United States
The U.S. Food and Drug Administration (FDA) is the competent authority governing food products (including dietary supplements) in the United States. It is primarily responsible for market access regulation, product quality oversight, and post-marketing supervision of dietary supplements nationwide. The FDA publishes monthly updates to the import refusal list for imported products on its official website.
Official Website of the Regulatory Authority:https://www.fda.gov/food/dietary-supplements
Database Portal: https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances
Supervision and regulation
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)
FDA Food Safety Modernization Act (FSMA)
Title 21, Code of Federal Regulations (21 CFR)
Food classification
A dietary supplement is defined as an oral product intended to supplement the diet, containing one or more dietary ingredients including vitamins, minerals, herbs/botanicals, amino acids, and other dietary substances. It is produced in non-conventional food forms such as tablets, capsules, powders, softgels, gel gummies and liquids. A core regulatory restriction: Dietary supplements shall not bear claims to treat, diagnose, cure or prevent any disease.
Entry requirement
Responsible party information
Brand and product information
Product claims and corresponding active ingredients
Product labeling
In addition, the Quality Management System (QMS) requirements for dietary supplements in the U.S. include Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Critical Control Points (HACCP). All other import procedures shall comply with general U.S. food import requirements. If a product contains new dietary ingredients, a New Dietary Ingredients (NDI) Notification shall be submitted pursuant to the NDI Notification Process.
Registration language
English
Documents Required for Regulatory Filing
Facility Registration: Submitted online via the FDA system. Required information includes facility details, owner/operator information, U.S. Agent information (for foreign facilities), and food category classification (covering dietary supplements).
NDI Notification (if applicable): Required content includes:
- Name and address of the manufacturer/distributor
- Name, composition and manufacturing process of the new dietary ingredient
- Recommended dosage and conditions of use
- Supporting safety evidence (including scientific literature, toxicological studies, etc.) to demonstrate that the ingredient is reasonably expected to be safe under intended use
Labeling Compliance Documentation: Products shall conform to all labeling requirements, including the Supplement Facts panel, ingredient list and compliant claim statements.
Filing Timeline
For general dietary supplement products: There is no mandatory pre-market approval or filing timeline. Manufacturers are responsible for conducting safety assessments and ensuring full labeling compliance, after which products may be placed on the market directly under the U.S. post-market regulatory framework.
Filing Procedure
七、FAQ
Q：What is the scope of FDA's oversight of food facilities?
A：FDA Regulates all foods and food ingredients introduced or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the United States Department of Agriculture (USDA).
The Human Food Program (HFP) works with FDA field offices to ensure that countries' food supplies (with the exception of meat, poultry, and some egg products, which are regulated by the USDA) are safe, hygienic, healthy, and honestly labeled, and that products are safe and properly labeled.
