Food supplements & preparations export rules: United States

Rules to check before you export food supplements & preparations to the United States (7), each with its official source.

Official sources checked between 2026-10-09 and 2026-10-15

Duty and FTAs: US duty within this HS code is 0–12.5% depending on the 10-digit line (12.5% Section 301, Section 232 or exempt). Check your HTS line before you quote. hts.usitc.gov, checked 2026-10-14

This is not legal or tax advice. Rules and rates change, so confirm with the official source and a local authority, your importer or an expert before you sell.

• Main rule for food supplements & preparations: Dietary supplement rules (DSHEA): Supplement Facts label, no disease claims, FDA facility registration, manufacturing under supplement cGMP (21 CFR 111); your US importer verifies you under FSVP. Claims about how it supports the body (structure/function claims) need the FDA disclaimer on the label and a notice to FDA within 30 days of first marketing (21 CFR 101.93). fda.gov, checked 2026-10-09, ecfr.gov, checked 2026-10-09, fda.gov, checked 2026-10-09, ecfr.gov, checked 2026-10-09
• US food facility registration renewal: Every factory that makes, packs or stores food for the US must be registered with FDA and renew the registration in each even-numbered year (2026, 2028 …) between 1 October and 31 December, with your DUNS number as the facility identifier and your US agent. A registration that is not renewed expires, and food from a foreign facility without a valid registration is held at the US port. Your company does it · ecfr.gov, checked 2026-10-14
• US Prior Notice for samples too: US Prior Notice covers food samples a business sends, including quality-control samples, not only orders (21 CFR 1.277). For courier samples by air the notice must be confirmed at least 4 hours before arrival; for international mail, file it before posting and write the PN confirmation number on the CN22 or CN23 form. Anyone who knows the shipment details may file it, so you can file for your own samples on FDA’s Prior Notice System Interface; without it the samples are refused and held at the port. Your company does it · ecfr.gov, checked 2026-10-15
• California Prop 65 warning for supplements: Supplements and plant-based products such as ginseng can carry trace lead and cadmium from soil, both on California’s Proposition 65 list, and notices to sue over lead in herbal supplements were filed again in 2026. A product sold in California needs a clear and reasonable warning unless the daily exposure stays at or below the safe harbor levels (lead 0.5 µg, cadmium 4.1 µg a day); expect US importers and retailers to ask for heavy-metal test results per daily serving. Done with your importer · oehha.ca.gov, checked 2026-10-15
• US contact on supplement labels for adverse events: A dietary supplement sold in the US must show a US address or US phone number on the label where consumers can report a serious adverse event; without it the product is misbranded (21 U.S.C. 343(y)). The company named on the label (maker, packer or distributor, often your US importer) must send each serious report to FDA within 15 business days. Agree whose name and US contact go on the label before you print. Done with your importer · govinfo.gov, checked 2026-10-15
• US: meat products need FSIS eligibility (pork from Korea is blocked): Food whose filling or recipe has more than 3% raw or 2% or more cooked meat, such as pork or beef dumplings, meat buns or sausages, is a USDA FSIS meat product, not an FDA food (72 FR 3779). FSIS takes meat products only from countries and plants on its eligibility list for that process category, and product from countries with African swine fever is ineligible (9 CFR 327.2); APHIS added South Korea to its African swine fever list in 2021 (86 FR 24378). Check the FSIS list before planning a meat line from Korea; a vegetable-only line follows FDA food rules. Your company does it · govinfo.gov, checked 2026-10-15
• California Prop 65 warning for seaweed: Seaweed can contain lead and cadmium, both on California’s Proposition 65 list. A product sold in California needs a clear and reasonable warning unless the daily exposure stays at or below the safe harbor levels (lead 0.5 µg, cadmium 4.1 µg a day). Businesses with fewer than 10 employees are exempt, but US importers and retailers usually are not, so expect them to ask for heavy-metal test results per serving or a warning label before they list it. Done with your importer · oehha.ca.gov, checked 2026-10-14
• Applies to every product here: No US de minimis for direct parcels
• Applies to every product here: US country of origin marking (19 CFR 134)
• Open the checklist
• Work out the export price
• Same product, other countries: Japan
• Same product, other countries: Malaysia
• Same product, other countries: India
• Same country, other products: Cosmetics
• Same country, other products: Instant noodles & pasta
• Same country, other products: Sauces & seasonings
• Same country, other products: Spirits (incl. soju)
• Same country, other products: Toys
• Same country, other products: Furniture
• Same country, other products: Pet food & feed
• Same country, other products: Medical devices
• Sources: fda.gov, checked 2026-10-09
• Sources: ecfr.gov, checked 2026-10-09
• Sources: fda.gov, checked 2026-10-09
• Sources: ecfr.gov, checked 2026-10-09
• Sources: ecfr.gov, checked 2026-10-14
• Sources: ecfr.gov, checked 2026-10-15
• Sources: oehha.ca.gov, checked 2026-10-15
• Sources: govinfo.gov, checked 2026-10-15
• Sources: govinfo.gov, checked 2026-10-15
• Sources: hts.usitc.gov, checked 2026-10-14
• Sources: hts.usitc.gov, checked 2026-10-14

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