Manufacturers and sellers of dietary supplements in the US must comply with various FDA requirements to ensure the safety, quality and labeling of products being offered for sale in the US.
Key FDA requirements are:
Facilities manufacturing, packing, or storing dietary supplements must register with the FDA. Registration helps the FDA identify and monitor industry participants. Registration must be renewed biennially, and any changes to facility information must be updated.
Dietary supplement labels must be truthful and not misleading. Labels must accurately represent the product’s ingredients, content, and intended use. A Supplement Facts panel must be included on the label, providing information on serving size, ingredients, and nutrient content per serving. Allergen labeling is required to inform consumers of the presence of major food allergens, if applicable. Dietary supplement manufacturers are prohibited to make drug claims such as treat, cure, diagnose, or prevent diseases.
- Current Good Manufacturing Practices (GMP):
Dietary supplement manufacturers are required to follow GMP regulations. GMP regulations establish standards for the production, packaging, labeling, and storage of dietary supplements. Compliance with GMP helps ensure that dietary supplements are manufactured consistently and meet quality standards. Facilities must maintain detailed records and establish quality control procedures.
- New Dietary Ingredients (NDIs):
Manufacturers intending to use a new dietary ingredient (an ingredient not marketed in the U.S. before October 15, 1994) must submit a notification to the FDA at least 75 days before marketing the product. The notification must include evidence demonstrating that the NDI is reasonably expected to be safe for use in dietary supplements.
- Adverse Event Reporting:
Manufacturers and distributors of dietary supplements are required to submit reports to the FDA regarding any serious adverse events associated with their products.
- Imports:
The FDA regulates imported dietary supplements to ensure they meet the same safety and labeling standards as domestically produced supplements. Imported supplements may be subject to inspection and testing at US ports of entry.
- Enforcement:
The FDA can take enforcement actions against manufacturers and distributors that violate regulations, including issuing warning letters, initiating recalls, and seizing products.
Liberty Management Group Ltd. provides assistance with FDA registration and label compliance.
Namrata
Regulatory Consultant
support@libertymanagement.us