Call Issued for FDA Enforcement of NDI Requirements

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WholeFoods Magazine Staff
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Washington, D.C.—Certain supplement ingredients may have entered the U.S. market without accompanying new dietary ingredient (NDI) notification as is required by the U.S. Food and Drug Administration (FDA).

U.S. Representative Steve Stockman (R-TX) sent a letter expressing his concern on the matter to Margaret A. Hamburg, M.D., FDA Commissioner. According to his letter, Stockman was alerted by three unnamed reputable corporations of multiple Chinese companies that brought supplements onto the U.S. market without submitting NDI notifications. Ingredients in question include zinc carnosine, pyrroloquinoline quinine (better known as PQQ) and astaxanthin. His concerns lie in the safety of supplements made with these ingredients, which have not gone through the proper channels for legal sale and may present a potential public health risk.

According to the Federal Food Drug and Cosmetic Act, manufacturers that wish to introduce a new dietary ingredient into the U.S. market must submit proper notification to the FDA 75 days prior marketing unless it can be proven the ingredient is chemically identical to an ingredient already on the market. This notification is necessary to ensure the safety of the supplement, as well as the reliability and control of the company’s process.

Marc Ullman, partner in Ullman, Shapiro & Ullman, LLP, New York, NY, is concerned about the lack of FDA regulation. “All three manufacturing companies I’m working with have gone through the appropriate NDI filing processes. They’ve spent a lot of time and money developing their ingredients and safety data, and now we’re seeing knockoff ingredients from people who say, ‘We want to sell a supplement and because we didn’t bother spending any money demonstrating that we know what we’re making is safe, we can sell it for less money.’ So, you have companies selling these ingredients, and we have no clue that they know what they’re doing, no clue that it’s controlled.” He fears that the lack of regulation could lead to a public health risk, which would “jeopardize the integrity of the entire industry.” Ullman urges FDA to take action against the knockoffs. “It should be relatively easy to do. Most are from China; put in an import alert and stop this stuff at the border.”

Stockman concluded his letter with a request that FDA remove the unexamined products from the market until NDI notification is properly filed.

Published in WholeFoods Magazine, December 2013 (online 11/4/13, updated 11/11/13)