Ullman Quoted on FDA’s Rejection of NDIN for Kratom
February 2, 2022 |Marc Ullman talked with Nutraingredients-USA for the article, “Sixth time still not a charm: FDA again rejects NDIN for Kratom.”
Despite five prior attempts, FDA rejected the latest New Dietary Ingredient (NDI) notification for kratom. American Botanicals Corp. filed three of the six, and the most recent filing is the topic of this article.
Marc said, “Having looked at the notification, it’s hard to characterize the submission as serious given that FDA has already questioned the data in two previous filings, and for this third attempt the company is still unable to characterize their ingredient.”
Despite FDA taking enforcement actions against kratom, the product is still widely available. “FDA enforcement against kratom has been sporadic,” Marc noted. “If you can find it for sale on the internet, then FDA certainly can find it if it really cared.”
