FDA clarified its position on the botanical kratom recently with an import alert that authorized seizure without examination and stated that kratom is a new dietary ingredient without a history of safe use.

The agency on Feb. 28 issued an import alert for kratom (mitragyna speciosa korth) due to an increase in the shipments of supplements and bulk ingredients in capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves and bulk liquids made of leaf extracts. The alert, which lists firms in Canada, Indonesia and Malaysia as importers, said imports of kratom in finished supplements or bulk ingredients are subject to detention without physical examination.

Maeng Da Kratom Capsules are of SNI National’s kratom products distributed as dietary supplements that were recalled after FDA discovered the primary ingredient did not meet regulatory criteria “as having all the information necessary to deem it as a safe ingredient.”

From FDA website

Although FDA cautioned manufacturers about kratom’s safety as a dietary ingredient in 2013, industry stakeholders posited that the agency should clarify whether the botanical is a legitimate supplement ingredient Also see "Kratom Action Presents Regulatory Puzzle For FDA" - Pink Sheet, 4 October, 2013..

By stating that kratom is an NDI without a history of safe use and authorizing seizures without examination, the import alert should answer that question for manufacturers.

“I think the import alert is very clear as far as our position on kratom,” said Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs.

Additionally, on March 14 SNI National announced a recall of kratom products it markets – Kratom XL, Maeng Da Kratom,Max Kratom and Bali Kratom –from distributors and retailers. The Ogden, Utah, firm said the recall was initiated after FDA discovered that the products were distributed as dietary supplements but the primary ingredient did not meet regulatory criteria “as having all the information necessary to deem it as a safe ingredient.”

Both the import alert and SNI’s recall announcement say:

“Kratom is a botanical that qualifies as a dietary ingredient under” FDA regulations.
“When marketed as a dietary ingredient, FDA considers kratom to be 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.”
“Scientific literature discloses serious concerns regarding the toxicity of kratom in multiple organ systems.”
“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting and severe withdrawal signs and symptoms.”

Although dietary supplement marketers and other firms in FDA-regulated industries publish their own recall announcements, agency officials offer assistance writing the notices, including providing suggested language, to make sure the announcements are accurate and comprehensive.

New Information Could Change Status

While FDA currently deems kratom as an NDI without history of safe use, a firm could submit a notification to the agency with evidence supporting its safe use.

NDI notifications are required at least 75 days before a product is marketed with an NDI, but firms are not required to wait for FDA’s decision on an ingredient before launching the products. However, should FDA determine that the subject of an NDI notification is not fit for use in dietary supplements, the agency can require that products containing the ingredient are pulled from the market.

Fabricant said kratom’s pharmacological profile and the apparent effects it causes for users, including opioid-like symptoms, render the substance unlikely to be allowed for use in dietary supplements.

“We don’t see that as being appropriate for the dietary supplement space,” he said.

Fabricant acknowledged, though, that U.S. consumers have access to kratom products online and in some retail venues.

“That’s one of our concerns. We want to make sure that folks aren’t selling illicit substances through our regulatory paradigm,” he said.

SNI National products were sold to wholesale distributors in Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts and Ohio.

Kratom is a tropical deciduous and evergreen tree native in Southeast Asia, where its leaves long have been chewed for medicinal purposes but also can be used for narcotic effect. Kratom is in the same biological family as coffee, rubiacea.

The Drug Enforcement Administration includes kratom on its list of drugs and chemicals of concern, though it has not listed the ingredient as a controlled substance. A DEA fact sheet notes pharmacology studies show mitragynine, the primary active alkaloid in kratom, has opioid-like activity in animals.

Kratom Import Alert Clarifies FDA Deems The Botanical An Unsafe NDI

More from Canada

More from North America