Exporting Dietary Supplements to the United States: FDA Requirements for Foreign Manufacturers

Dietary supplements are one of the fastest-growing product categories imported into the United States, and foreign manufacturers from India, China, South Korea, Japan, and across Europe are increasingly looking to enter the US market. But dietary supplements occupy a unique regulatory position under US law — they are not drugs, they are not conventional foods, and they follow their own set of rules under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and subsequent FDA regulations. Foreign manufacturers who assume that dietary supplement compliance is similar to food or drug compliance will encounter requirements they did not expect and gaps where they assumed protections existed.

FDA facility registration for dietary supplement manufacturers

Every foreign facility that manufactures, processes, packs, or holds dietary supplements for consumption in the United States must register with the FDA as a food facility under the Bioterrorism Act. Dietary supplements are regulated as a subcategory of food, not as drugs, which means the facility registration process follows the same path as food facilities — you need a DUNS number from Dun & Bradstreet, a designated US Agent with a physical US address, and accurate facility identification including your legal entity name and product category classifications. The registration must be renewed biennially during the October–December renewal window in even-numbered years. An expired registration means your products cannot legally enter the United States.

Current Good Manufacturing Practices under 21 CFR Part 111

Unlike conventional food, which follows GMP under 21 CFR Part 117, dietary supplements have their own dedicated GMP regulation under 21 CFR Part 111. These rules are more prescriptive than food GMP and cover personnel qualifications, physical plant and grounds, equipment and utensils, production and process controls, holding and distribution, returned products, and product complaints. The regulation requires identity testing of every incoming ingredient — not just a certificate of analysis from the supplier, but actual testing by the manufacturer or a qualified laboratory. It also requires specifications for finished product identity, purity, strength, composition, and limits on contaminants. Foreign manufacturers accustomed to working under food GMP or pharmaceutical GMP will find 21 CFR Part 111 has its own specific requirements that do not map perfectly to either framework.

Ingredient restrictions and the New Dietary Ingredient notification

Under DSHEA, dietary ingredients that were marketed in the United States before October 15, 1994, are considered old dietary ingredients and do not require pre-market notification to the FDA. However, any dietary ingredient that was not marketed before that date is considered a New Dietary Ingredient (NDI) and the manufacturer or distributor must submit a pre-market notification (NDI notification) to the FDA at least 75 days before introducing the product into interstate commerce. The notification must include the history of use or other evidence of safety establishing that the ingredient, when used under the conditions recommended or suggested in the labeling, will reasonably be expected to be safe. The FDA can reject the notification if the safety evidence is insufficient. Foreign manufacturers often assume that because a plant extract or compound is widely used in traditional medicine in their home country, it qualifies as an old dietary ingredient — this is almost never the case. The pre-1994 marketing history must be in the United States, not globally.

Labeling requirements for dietary supplements

Dietary supplement labeling follows specific FDA rules that differ from both food and drug labeling. The label must include a Supplement Facts panel (not a Nutrition Facts panel), a complete list of ingredients, the name and address of the manufacturer, packer, or distributor, net quantity of contents, and the statement required by DSHEA that the product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. Structure/function claims — statements about the effect of the supplement on the body's structure or function — are permitted but must be truthful and not misleading, and the manufacturer must have substantiation on file. Disease claims are prohibited. The line between a permissible structure/function claim and a prohibited disease claim is narrow and frequently misunderstood by foreign manufacturers.

How FDABridge helps dietary supplement exporters

FDABridge handles FDA facility registration, US Agent designation, label compliance review, and regulatory guidance for foreign dietary supplement manufacturers. Our team understands the specific requirements of 21 CFR Part 111 and the DSHEA framework, and we can identify compliance gaps before your products reach a US port. Visit fdabridge.com/food to explore our services or fdabridge.com/contact to get started.