FDA Waves Stop Sign At Kratom Product Launch After Failed NDI Notification
This article was originally published in The Rose Sheet
FDA published an untitled letter the same day it was submitted stating that Industrial Chemicals' website includes statements on kratom's safety as a dietary ingredient and its pending launch of product sales even though the agency in December said an NDI notification the firm submitted in September did not establish safety for the use of mitragynine, an extract from dried kratom leaves, in a supplement branded Mitrasafe.
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First report of salmonella contamination for a kratom supplement in nearly nine months prompts Sunstone Organics to recall one lot each of its white vein and maeng da types of the herb. FDA's latest recall database update includes Nutrafuels' recall of more than 1,500 of its CTFO Oral Spray with pure CBD hemp oil isolate dietary supplements for sleep support, weight loss and pain relief after third-party testing showed microbial contamination.
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.
FDA regulation of kratom as an NDI is necessary to avoid untenable state regulations, says AHPA chief Michael McGuffin, adding the trade group's support to kratom experts' push to keep the herbal ingredient available. Experts also say salmonella issues currently linked to kratom could be an indirect result of FDA's import alert as noncompliant suppliers filled continued demand.