What to Know Before Selling Dietary Supplements in the U.S.

The U.S. is the world’s largest dietary supplement market but entry doesn’t come down to a single approval or certificate. It runs through five interconnected regulatory layers. Here’s everything you need to map out before shipping your product to the U.S.

1. Understand the DSHEA Framework

In the U.S., dietary supplements occupy a distinct legal category between food and drugs, defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under Section 201(ff) of the FD&C Act (21 U.S.C. § 321(ff)), a product qualifies as a dietary supplement if it:

• Contains a vitamin, mineral, herb/botanical, amino acid, or other substance intended to supplement the diet,
• Is in an oral form (tablet, capsule, powder, liquid, etc.),
• Is labeled as a “dietary supplement.”

If the label makes a disease treatment/prevention claim, the product is automatically regulated as a drug, subject to a completely different and far more demanding approval process (new drug application).

2. Register Your Food Facility

Dietary supplements fall under the food category in FDA regulation so the general Food Facility Registration requirement under FSMA (21 CFR Part 1, Subpart H) applies. This is a separate system from cosmetic facility registration under MoCRA. Key points for a foreign (Turkey-based) manufacturer:

• The facility must be registered with FDA and obtain a Unique Facility Identifier (UFI).
• Foreign facilities must designate a U.S. Agent. Based in the U.S., responsible for communicating with FDA.
• Registration information must be submitted in English, using the Latin alphabet (individual names, company names, street names, and trade names may be in a foreign language, but still in Latin script).
• Registration must be renewed every two years.
• Registration is free, but must be updated immediately if any submitted information is incorrect.

3. Screen Your Ingredients for NDI Status

This is the step most likely to cause delays. Any substance not marketed as a dietary supplement ingredient in the U.S. before October 15, 1994 is classified as a New Dietary Ingredient (NDI) (21 U.S.C. § 350b(d)). If your product contains an NDI:

• You must notify FDA at least 75 days before marketing.
• Without notification, the product is automatically deemed adulterated (FD&C Act §402(f), 21 U.S.C. § 342(f)).
• Even with notification, the product remains adulterated unless there’s adequate evidence the ingredient is reasonably expected to be safe.

Certain botanical extracts common in Turkey may fall into this category checking at the formulation stage is critical, since the 75-day period isn’t retroactive.

4. Ensure GMP Compliance

Dietary supplements must be manufactured under the cGMP rules in 21 CFR Part 111 covering raw material control, production processes, testing, and recordkeeping. Being able to document compliance matters both for FDA inspections and for additional documentation some platforms (like Amazon) may request.

5. Get Labeling Right

Dietary supplement labels must comply with general food labeling rules (21 CFR Part 101) as well as the supplement-specific “Supplement Facts” panel requirement. A missing or incorrect label renders the product misbranded.

6. Be Careful With Health Claims (Structure/Function Claims)

Dietary supplement labels can include structure/function claims statements describing how a nutrient supports the body’s structure or function, such as “supports bone health.” But if such a claim crosses into a disease claim (e.g., “treats osteoporosis”), the product is automatically regulated as a drug (21 CFR § 101.93(f)-(g)).

Any product using a structure/function claim has two obligations:

• The label must carry the following mandatory disclaimer, in boldface type: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
• FDA must be notified of the claim within 30 days of the product’s first marketing (21 U.S.C. § 343(r)(6); 21 CFR § 101.93(a)).

Quick Checklist

1. Does the product genuinely meet the DSHEA definition of a dietary supplement?
2. Is Food Facility Registration complete, and has a U.S. Agent been designated?
3. Does any ingredient qualify as an NDI? Has the 75-day notification been filed?
4. Does the manufacturing facility meet 21 CFR Part 111 GMP requirements?
5. Does the label include a complete Supplement Facts panel and all required elements?
6. If using a structure/function claim, is the mandatory disclaimer present and has the 30-day FDA notification been filed?

Sources: FD&C Act §§201(ff), 402(f), 413, 403(r)(6) (21 U.S.C. §§ 321(ff), 342(f), 350b, 343(r)(6)); 21 CFR Part 1 Subpart H (Food Facility Registration); 21 CFR § 190.6 (NDI notification); 21 CFR Part 111 (GMP); 21 CFR Part 101, § 101.93 (labeling and structure/function claim requirements); FDA Guidance for Industry — Dietary Supplements: New Dietary Ingredient Notifications.

This content is for general informational purposes and does not constitute legal advice. Confirm current requirements at FDA.gov/dietary-supplements and eCFR.gov.