FDA Dietary Supplement Registration & Compliance

Dietary supplement manufacturers must comply with FDA food facility registration, cGMP requirements, labeling regulations, and new dietary ingredient (NDI) notifications. LMG provides complete dietary supplement regulatory services.

21 CFR Part 111cGMP ComplianceNDI Notifications

Dietary Supplement Services

A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites. Dietary supplements can also be extracts or concentrates and may be found in many forms, such as tablets, capsules, soft gels, gel caps, liquids, or powders.

Under Dietary Supplement Health and Education Act, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. Also, manufacturers need to register themselves under the Bioterrorism Act with FDA before producing or selling supplements.

LMG assists dietary supplement manufacturers with FDA registration, cGMP compliance guidance, label review, and NDI notification preparation.

FDA Food Facility Registration

Dietary supplement manufacturers must register as food facilities with FDA. LMG handles complete registration including U.S. Agent designation and registration certificate.

Learn More

cGMP Compliance Guidance

Dietary supplement manufacturers must comply with 21 CFR Part 111 cGMP requirements. LMG provides guidance on cGMP obligations and inspection readiness.

Learn More

Supplement Label Review

Full FDA compliance review of your supplement facts panel, ingredient list, structure/function claims, and required FDA disclaimer statements.

Learn More

NDI Notification

New dietary ingredients introduced after October 15, 1994 require submission of a New Dietary Ingredient (NDI) notification to FDA at least 75 days before marketing. LMG assists with NDI preparation.

Learn More

How It Works

We manage the entire process from start to finish.

Regulatory Assessment

We assess your supplement formulation, ingredients, and claims to identify all FDA compliance obligations.

Registration & Compliance

We handle your FDA food facility registration and provide registration certificate after completion.

Label Review

We review your supplement facts panel, claims, and labeling for full FDA compliance before product launch.

Ongoing Support

We monitor FDA regulatory updates affecting dietary supplements and keep you informed of new requirements.

Frequently Asked Questions

Common questions about this FDA regulatory service.

Are dietary supplements regulated as food or drugs?

Dietary supplements are regulated as a special category of food under the Dietary Supplement Health and Education Act (DSHEA) of 1994 — not as drugs. However, they are subject to specific FDA regulations under 21 CFR Parts 101, 111, and 190.

What cGMP requirements apply to supplement manufacturers?

Dietary supplement manufacturers must comply with 21 CFR Part 111 — Current Good Manufacturing Practice requirements that cover identity, purity, strength, and composition of supplements.

What claims can dietary supplements make?

Dietary supplements may make structure/function claims (e.g., “supports immune health”) with the required FDA disclaimer. Health claims and nutrient content claims are also allowed with specific FDA requirements.

What is an NDI notification?

A New Dietary Ingredient (NDI) notification must be submitted to FDA at least 75 days before marketing a dietary supplement containing a new ingredient not marketed before October 15, 1994.