Failed NDIs, FDA's Opioid Concerns Don't Stop Kratom Supplement Sales

Proponents say the herbal ingredient extracted from a plant in the coffee family and available in powders, capsules or pills and beverages has been used in the US since long before the October 1994 grandfather date for ingredients to be eligible for use in supplements without being notified to FDA as new. But FDA wants NDI notifications, and the four submitted so far have been incomplete or did not show safety for intended use in a supplement.

Dietary supplements containing kratom remain available in the US even as FDA has found that new dietary ingredient notifications, including one the agency made a decision on as recently as April this year, have not shown safety for the botanical's intended use.

Marketers and other kratom proponents, however, argue that the herbal ingredient, identified as mitragyna speciose and extracted from a plant in the coffee family, has been used in the US since long before the October 1994 grandfather date for dietary ingredients to be eligible for use in supplement products without being notified

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