Kratom Advocates Spread False Hope to Addicts

The American Kratom Association (AKA) sells certifications for kratom products and has a vested interest in kratom becoming legal. AKA recently issued a press statement that contains misrepresentations about the FDA’s stance on Kratom:

The American Kratom Association (AKA) has presented a narrative suggesting a significant policy shift by the FDA towards kratom, particularly highlighting a statement made by FDA Deputy Commissioner Kimberlee Trzeciak. The AKA interprets these comments as signaling a new, more favorable regulatory approach to kratom, contrasting sharply with the FDA’s historical stance. This interpretation, however, seems to substantially diverge from the actual content and tone of Deputy Commissioner Trzeciak’s remarks and the official FDA position on kratom.

Trzeciak’s comments, rather than endorsing kratom or signaling a major shift in FDA policy, emphasize the complexity of regulating products like kratom and CBD, focusing on consumer safety, accurate labeling, and the avoidance of harmful events, especially in children. She mentions the need for collaboration with Congress and stakeholders to establish a regulatory framework, without providing specific support for kratom’s legality or safety.

Furthermore, the official FDA statement maintains a consistent stance that kratom is currently not approved for any medical use and highlights concerns over safety and efficacy. The statement categorically states that kratom is not legally marketable in the U.S. as a drug, dietary supplement, or food additive, reflecting ongoing concerns about the substance’s safety and regulatory status.

The discrepancy between the AKA’s optimistic interpretation and the actual content of FDA communications is stark. While the AKA suggests a positive shift in FDA policy based on Trzeciak’s comments, the full context of her statement and the official FDA position do not support this conclusion. Instead, they reflect ongoing regulatory concerns and a cautious approach to products like kratom, with a focus on consumer safety and proper labeling.

The full text of her comments are as follows:

Audience: We have a cannabis question. Can you tell us a little bit about how the Agency is prioritizing? They are regulating cannabis and even kratom is another one that I keep hearing about. Just tell us a little bit about it. This is one of those things that you never think is on FDA’s regulatory agendas. But it really has to be at this point.

Deputy Commissioner Kimberlee Trzeciak: In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom, and others. And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like? Based on what we know about CBD in particular, we do not think that those products would be able to meet the safety standards that we have in place for foods and dietary supplements today. What can we do in terms of regulatory tools to ensure that this product is going to be marketed that consumers are clearly aware of what the product is, what is in it, and making sure that we have basic information about the marketplace? I like to think of it as the common regulatory tool that we have across the other products that we regulate.

We want to work with Congress on this effort, but thinking through how do we ensure that it is clearly labeled, so that way CBD is not making its way into the hands of children. For example, how can we ensure that the Agency knows if there are adverse events that are being reported, so we can identify those trends, making sure that the product is being manufactured or produced in a way that’s safe and quality? Making sure that we know who is making it is what is also very important and where they’re making it. We have been actively thinking through that. It is really going to take collaboration with the Hill and with stakeholders. I think we have a lot of experience from the other products that we have regulated about what are the basic regulatory tools that we think would be most beneficial, but we also need to have a better sense from the Hill and from stakeholders about where those lines need to be drawn in terms of the safety of the products. What kind of level of oversight do we want for them? I think one of the most important things, though, is that there is, I would hope, common ground on wanting to make sure that products like, with CBD and Kratom, consumers are educated about what they are taking, and when we have seen some harmful events happen with children. That is something that we want to make sure of, that if we are going to move forward on a regulatory framework, we are doing it in such a way that we are hoping to minimize some of those events.

Additionally, the FDA has updated it’s kratom bulletin to state:

Kratom is not appropriate for use as a dietary supplement. FDA has concluded from available information, including scientific data, that kratom is 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 and, therefore, dietary supplements that are or contain kratom are adulterated under section 402(f)(1)(B) of the FD&C Act. Further, FDA has determined that kratom, when added to food, is an unsafe food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a)(2)(C)(i). Based on these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.

And view the full transcript here:

Alliance Webinar Series_Webinar Transcript Featuring Kimberlee Trzeciak, FDA Deputy Commissioner for Policy… by Matt Wetherington on Scribd