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FDA Begins Stopping NDIs at the Border

Supplement Counsel

NDIborder4As we’ve previously reported, FDA has not released a revised draft guidance—let alone a final guidance—on New Dietary Ingredients (“NDI”) in dietary supplements.  Despite that fact, FDA has continued to enforce its NDI regulations.  But while industry has previously faced warning letters after failing to comply with NDI notification requirements, FDA seems to be turning to other methods of enforcement.

FDA has begun to detain imports of some dietary supplements and dietary ingredients, saying that the products violate its NDI notification requirements.  In the past, a company selling a product containing an NDI for which the company has not filed an NDI notification might receive a warning letter—as USP Labs did last year after its Oxy Elite Pro product (with the NDI “aegeline”) reportedly caused a series of liver failures across the country.  Now, however, companies that import their ingredients may have them seized at the border if they violate FDA’s NDI regulations.

Recently, for example, FDA issued an import alert for kratom.  This alert advises FDA to detain, without physical examination, shipments from a number of designated firms that have previously shipped kratom into the United States.  And the reason for the import alert and seizures?  Kratom is an NDI and there is no evidence that it is safe—a necessary component of a successful NDI notification.  FDA’s alert provides:  “In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under [the Food, Drug, and Cosmetic Act], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

Additionally, The Tan Sheet reports that FDA has been detaining synthetic botanicals at the border.  The reason for these seizures can also be found in FDA’s 2011 draft NDI guidance:  FDA does not consider synthetic botanicals to be “dietary ingredients,” and they therefore cannot legally be used in dietary supplements.

So how can you minimize the risk of your ingredient being detained as it enters the United States?  Keep track of FDA’s import alerts to make sure you’re not shipping in any detainable ingredients.  You should also know your supplier—if it has faced import problems in the past, it may face them again in the future.  Finally, it is a good idea to address any import-related concerns in your contract with the supplier.

As always, if you have questions about NDIs, import alerts and detentions, or any other aspect of dietary supplement law, contact us anytime at 516-294-0300.

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