FDAストーリー #016 — エジプトのナツメヤシ輸出業者のPrior Noticeに誤ったFDA登録番号があった

A matcha company in Uji, Kyoto, produced a premium ceremonial-grade matcha powder that they sold in Japan as a traditional tea. When they expanded to the US, their American distributor suggested adding health claims to the marketing: 'Boosts energy naturally,' 'Supports immune function,' 'Rich in antioxidants for cellular health.'

The product was labeled as a food with a Nutrition Facts panel. The marketing materials — on the website, on Amazon, and on shelf talkers — contained structure/function claims.

問題

Under US law, a product that makes structure/function claims — claims about how a substance affects the structure or function of the body — is either a dietary supplement (if it contains a dietary ingredient and is intended for ingestion) or a drug (if the claims go further into disease treatment). A conventional food cannot make structure/function claims without triggering reclassification. 'Boosts energy' and 'supports immune function' are structure/function claims that pushed the matcha from the food category into the dietary supplement category.

As a dietary supplement, the product needed a Supplement Facts panel (not Nutrition Facts), the required disclaimer ('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'), a structure/function claim notification filed with the FDA within 30 days of first marketing, and facility registration under the dietary supplement CGMP requirements of 21 CFR Part 111.

解決策

The company had two paths. They could remove all structure/function claims and sell the matcha as a conventional food — which would require only the standard food facility registration and a Nutrition Facts panel. Or they could keep the claims and comply with dietary supplement regulations. They chose to sell the matcha as a conventional food in retail stores (no health claims) and as a dietary supplement through their e-commerce channel (with compliant claims and labeling). Two SKUs. Two labels. Two regulatory pathways from the same facility.

If your product is a tea, powder, extract, or botanical and you want to make health-related claims in the US — you are almost certainly selling a dietary supplement, not a food. The labeling, registration, and compliance requirements are different. Get it right before you launch. fdabridge.com/contact.