NDC Number for Dietary Supplements & Medical Food

Dietary supplements are not drugs — they are regulated as a category of food under the Dietary Supplement Health and Education Act (DSHEA) of 1994. As such, dietary supplement manufacturers do not obtain NDC (National Drug Code) numbers through the drug establishment registration process.

Some dietary supplement manufacturers incorrectly try to register their products as drugs to obtain an NDC number for use on labels. This is not the correct approach and can result in misbranding.

What dietary supplements need: FDA food facility registration (via FURLS), label compliance, compliance with dietary supplement GMPs (21 CFR Part 111), and Structure/Function claim notifications to FDA if applicable.

Medical foods (formulated to be consumed under medical supervision for specific diseases) are also regulated as foods, not drugs, and do not use NDC numbers.

Note: Some product types can be both a drug AND a dietary supplement depending on how they are labeled and marketed. If a product makes drug claims, it may need to comply with drug regulations. Contact LMG for guidance.

• Dietary supplements require FDA food facility registration (not drug registration)
• Comply with FDA labeling regulations
• Comply with dietary supplement GMPs: 21 CFR Part 111
• Structure/Function claims require FDA notification within 30 days of first marketing
• Medical foods require food facility registration and medical supervision context
• NDC numbers are for drug products only — not dietary supplements or medical foods