Sixth time still not a charm: FDA again rejects NDIN for kratom

The unsuccessful NDI notification, submitted by American Botanicals Corporation (NDIN #1220), marks the sixth time an NDIN has been filed with the agency for kratom. All have been unsuccessful*.

Three of the six attempts have been filed by American Botanicals Corporation. In its new response, which can be found HERE​​, FDA stated that it has significant concerns about the evidence presented, noting that it was unable to establish the identity of the ingredient described as a ‘kratom extract’.

The Agency also said there was insufficient documentation around composition, manufacturing processes, analytical data to verify specifications, and a history of safe use. 

“In addition, FDA was unable to establish the safety of your new dietary ingredient, “kratom extract”, based on “other evidence of safety” provided in your notification. Your current notification contains the same toxicology studies that were relied upon in your previous submissions. FDA objected to your previous new dieta1y ingredient notifications #992 and # 1063 in part because you did not include adequate “other evidence of safety”,”​ added FDA in its response to American Botanicals Corporation.

Attempts to contact American Botanicals Corporation were unsuccessful.

“An extremely high bar”​

Commenting independently on the news, Marc Ullman, Of Counsel at Rivkin Radler LLP, told NutraIngredients-USA: “Having looked at the notification, it is 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.”​

Ullman added that he has previously worked with a different company that was very serious about filing an NDIN for kratom but eventually moved on “because it is an incredibly challenging ingredient”​.

“FDA is hostile to the ingredient, and that means you have an extremely high bar,” ​he said.

Efficacy… but concerns​

As of today, the FDA has not approved any uses for kratom and its key bioactives mitragynine and 7-hydroxymitragynine, and the Agency has voiced safety concerns about the plant, according to FDA’s dedicated page to the botanical​. Some US states have banned the botanical, while several states, including Utah​ and Arizona​, regulate its use.

The WHO’s Expert Committee on Drug Dependence (ECDD)​ recently concluded that “there is insufficient evidence to recommend a critical review of kratom”​ but recommended that kratom, mitragynine and 7-hydroxymitragynine “be kept under surveillance by the WHO Secretariat”​.

The main benefits cited by users include managing chronic pain and helping with opioid addiction, and researchers from Johns Hopkins University​ have called on the FDA to regulate kratom, and for rigorous clinical research to explore the potential therapeutic benefits.

“On its face, it is not a legal dietary ingredient”​

Despite its potential efficacy, some stakeholders are not convinced that kratom is a dietary ingredient. Speaking with NutraIngredients-USA towards the end of 2021, Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), told us that his organization recommends that member companies to not sell products containing kratom.

“The regulations are pretty clear in the US,”​ he said. “It has not been the subject of a successful New Dietary Ingredient Notification (NDIN), nor has a serious NDIN been filed. On its face, it is not a legal dietary ingredient.” ​

Ullman added that he is not optimistic about anyone achieving a successful NDI notification for kratom because of the toxicological challenges.

Use​

Despite all this, interest in kratom has been increasing in the US with between 10 and 16 million Americans regularly using kratom as a food, supplement or a tea, according to the American Kratom Association (AKA).

While the FDA has run enforcement actions against kratom products, many products remain commercially available.

“FDA enforcement against kratom has been sporadic,”​ said Ullman. “If you can find it for sale on the internet, then FDA can certainly find it if it really cared.”​

CRN’s Mister concurred: “FDA is not enforcing the law. It is not sending out a strong message that kratom is not a legal ingredient. The Agency needs to walk with a big stick and aggressively police this. ​

“The industry should not be selling it unless it is committed to filing a serious NDIN,” ​added Mister.