Selling Food Supplements in the US: FDA DSHEA Compliance for Taiwan Brands

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements as a distinct product category in the US — not food, not drugs — and establishes the regulatory framework for their sale. If you sell vitamins, minerals, herbs, botanicals, amino acids, probiotics, or other "dietary ingredients" in capsule, tablet, powder, or liquid form, DSHEA applies to you.

Under DSHEA, dietary supplement manufacturers are responsible for ensuring their products are safe before bringing them to market. The FDA does not pre-approve supplements — but the FDA does enforce standards post-market and can take action against unsafe products, false claims, or adulterated products.

For Taiwan brands: if you manufacture supplements in Taiwan and import them for US sale, you are the importer of record and bear full DSHEA compliance responsibility. Your Taiwan GMP certification is a starting point, but US-specific compliance steps are required in addition.

FDA's 21 CFR Part 111 mandates that all dietary supplement companies follow Current Good Manufacturing Practices. CGMPs require: identity, purity, strength, and composition of finished products to be verified; written procedures for all manufacturing steps; batch records for every production run; laboratory testing of incoming ingredients and finished products; and qualified personnel for all critical operations.

US supplement retailers (including Amazon) and distributors increasingly require manufacturers to hold NSF Certified for Sport, NSF International GMP, or USP Verified certifications. These third-party GMP certifications go beyond FDA minimum requirements and are the market-expected standard for credible brands.

Taiwan manufacturers: if your factory holds ISO 22000 or HACCP certification, these cover food safety management but are not equivalent to US dietary supplement CGMPs. If your factory holds Taiwan GMP or PICS GMP, these are closer but still require a gap analysis against 21 CFR Part 111 before claiming US CGMP compliance.

Third-party US facility registration: your supplement manufacturing facility (even if in Taiwan) must be registered with the FDA under the FDA Food Safety Modernization Act (FSMA). Register at the FDA's Food Facility Registration system. Registration is free and required to legally import supplements into the US.

Every US dietary supplement must have a Supplement Facts panel (analogous to a Nutrition Facts panel on food). Required elements: serving size, servings per container, list of dietary ingredients with amount per serving, % Daily Value if established, and "†" footnote disclaimer for ingredients without a DV.

Other required label elements: product name and form (tablet, capsule, softgel), net quantity of contents, manufacturer or distributor name and address, directions for use, and any required warnings (e.g., "Keep out of reach of children," "Consult a physician before use if pregnant or nursing").

All label text must be in English (FDA does not accept English/Chinese bilingual panels for US market products). Translations for non-English communities are permitted as supplemental materials but the principal display panel must be English.

Allergen declaration: under FALCPA, if your supplement contains any of the major 9 allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame), they must be declared on the label.

DSHEA permits "structure/function claims" — statements describing how a nutrient or ingredient affects normal body structure or function. Examples: "Calcium builds strong bones," "Vitamin C supports the immune system," "Probiotics support digestive health."

Disease claims are prohibited without FDA drug approval. A disease claim implies the product treats, cures, or prevents a specific disease. Prohibited examples: "Treats arthritis," "Cures insomnia," "Prevents heart disease." The line between structure/function and disease claims is legally significant and frequently enforced.

Required disclaimer for structure/function claims: every supplement label with a structure/function claim must include in bold text: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

FDA Notification: within 30 days of first marketing a supplement with a structure/function claim, the manufacturer must notify FDA of the claim. This is a simple online notification, not an approval process — but skipping it is a violation.

Amazon has additional requirements beyond FDA compliance for supplements sold on the platform. Amazon requires: product images that show the complete Supplement Facts panel, no unauthorized health claims in listing title or bullets, and in some categories, third-party COA (Certificate of Analysis) from an accredited lab.

Amazon's "restricted supplements" list includes many popular ingredients (certain herbal extracts, high-dose vitamins, weight loss ingredients) that require pre-approval or documentation before listing. Check Amazon's Dietary Supplements listing requirements in Seller Central before creating any supplement listing.

FBA supplement considerations: some supplement ingredients trigger Amazon's HAZMAT review process. Liquid supplements may require special packaging. Probiotics may require refrigeration disclosures. Review FBA eligibility for your specific formulation before sending inventory.