A dietary supplement manufacturer in Guangzhou was preparing to export a Traditional Chinese Medicine-inspired supplement capsule to the United States. The product contained a blend of botanical extracts including one ingredient — a specific plant extract — that had been used in Chinese herbal medicine for centuries and was widely sold as a health product across Asia.
The ingredient had no history of marketing in the United States before October 15, 1994.
Why that date matters
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), any dietary ingredient that was not marketed in the US before October 15, 1994, is classified as a New Dietary Ingredient (NDI). Before marketing a product containing an NDI, the manufacturer or distributor must submit an NDI notification to the FDA at least 75 days before introducing the product. The notification must demonstrate a reasonable expectation of safety based on the ingredient's history of use or other evidence.
The Guangzhou manufacturer had not filed an NDI notification. They assumed that centuries of use in China constituted sufficient safety evidence. Under US law, it does not — unless that evidence is compiled in a formal NDI notification and submitted to the FDA. Without the notification, the product containing the NDI is adulterated under Section 402(f) of the FD&C Act.
The refusal
The first shipment — 2,000 bottles valued at approximately $28,000 — was refused entry at the Port of Long Beach. The FDA's import screening flagged the product because the ingredient appeared on FDA's internal list of NDIs without active notifications. The refusal was immediate. The product was not examined, not tested — simply refused based on the ingredient list and the absence of a valid NDI notification in FDA's database.
What we did
We worked with the manufacturer to evaluate their options. Filing an NDI notification would take at least 75 days plus preparation time and would require compiling safety data — toxicological studies, published literature, and documentation of the ingredient's history of use. The alternative was to reformulate the product using only ingredients with established US dietary ingredient status. They chose reformulation for speed and filed the NDI notification separately as a longer-term project. The reformulated product entered the US market 8 weeks later.
If you manufacture dietary supplements and you use ingredients sourced from traditional medicine systems — Ayurveda, TCM, Unani, Kampo — check the NDI status of every ingredient before you ship. fdabridge.com/contact.
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