FDA DOSE FINDING STUDY — What it Actually Means to Kratom Consumers

 

March 26, 2024

FDA DOSE FINDING STUDY — What it Actually Means to Kratom Consumers

The FDA completed a Single Ascending Dose (SAD) human safety study on kratom that delivered the truth about kratom — “

A SAD study is a type of a Phase I safety trial and are usually conducted in a small number of healthy volunteers. The aim is to find out the safe dose range, and to look for any serious side effects of the substance being tested. The initial dose given will be very small and increased gradually (in a new group of volunteers) if no or only mild side effects are seen. Researchers will also take measurements to determine how the medicine is processed in the body.

What is very important is why the FDA conducted a SAD human safety study in the first place. The bottom line is the FDA has been repeatedly embarrassed by the lack of safety evidence and data on kratom, so they launched an effort to buttress their claims that kratom is dangerous.

A report from a source who wants to remain anonymous, but who was directly involved in reviewing the SAD study, reported the FDA policy staff were “profoundly disappointed” in the results. FDA scientists, however, were accepting of the results.

FDA Supervisory Pharmacologist, Controlled Substances Staff, Chad Reissig, made a presentation to the Third International Kratom Symposium, Orlando, Florida, February 14-15, 2024 on a kratom safety study administered by the FDA.

Here are the highlights of presentation by Mr. Reissig on the SAD safety study on kratom:

  • There were 40 human participants — 5 cohorts with 8 participants, and 2 placebo doses were given in each cohort.
  • The study dosed at intervals of 1, 3, 8, 10, and 12 grams (each gram is two capsules so at 12 grams, the participants were required to consume 24 capsules in a 5 minute period.
  • The full results of the study will be made public later in 2024.

The results Mr. Reissig shared are significant :

  • There were no serious Adverse Events; no concerns with vital signs; no electro cardio events; or physical abnormalities within the full dose range.
  • Two events of nausea and vomiting in the 12g dose – with participants required to consume 24 capsules within 5 minutes.
  • No subjects reached ‘stopping criteria’ – i.e.: a subject exhibited symptoms that would mean they should stop the test.

So, the bottom line, is that 2 of the 40 study participants experienced nausea at 12 grams of kratom — 24 capsules that had to be consumed in 5 minutes.

Tampa Bay Times was Featured on the Wave Makers Podcast

Producers and hosts Janet and Tom Scherberger of the podcast Wave Makers, a podcast that features companies and individuals who are “making a difference in the Tampa Bay region”, hosted two reporters from the Tampa Bay Times. It should be noted that the episode was sponsored by the Tampa Bay Times.

The American Kratom Association (AKA) was also invited to contribute to the segment. It was our understanding that the interview was to be split and impartial, though it turned into anything but. However, we managed to set the record straight on several vital facts about the AKA’s commitment to consumer protection, the FDA’s bias against kratom, the need for more rigorous and standardized toxicology testing to accurately label deaths characterized as “kratom only”, and the irresponsible reporting of the TBT.

Here are some of the points I was able to make during the interview:

“One of the unfortunate characterizations from the Tampa Bay Time series is that we do not support [measures for consumer protection]. It is untrue. We are a consumer advocacy organization, and one of the things we agree with the TBT about is that there needs to be a lot more labeling transparency and clarity.”

“…the one word that you have not mentioned on this show today, that should have been mentioned, and these reporters should have done it, is ‘adulterated’ kratom products…this market place, because of the FDA’s refusal to regulate, is flooded with adulterated kratom products that are responsible for adverse events.”

“The proof is in the data [the TBT] has analyzed…where… kratom is detected on board with fentynal…we know that there are adulterated fentynal products with kratom in them that create these kind of problems. And it is irresponsible of the TBT…to characterize [these deaths], with their theories, [as a] deadly dose. Because the truth is, there is not a single scientist in America that can document that there is a deadly dose of kratom that can cause an overdose death. And they know it, and they refuse to report it.”

“The truth is the CDC and the New England Journal of Medicine have both examined the protocols for medical examiners, claiming these deaths are related to kratom, and they find them to be insufficient in terms of those protocols.”

Click here to listen to the podcast

Keep Kratom Safe Webinar- Announcement of our Legacy Hall of Fame Inductees

In 2016, when the FDA tried to abuse the “Emergency Power Section” of the Controlled Substances Act (CSA) and classify kratom as a Schedule I drug, the outcome felt assured. The FDA had successfully scheduled 82 substances, prior to their attack on kratom, using this provision of the CSA. However,  the kratom advocacy community stood up to the FDA and kept kratom legal and accessible for millions of American consumers. We want to acknowledge many of the early pioneers and foot soldiers who were instrumental in these efforts:

Scientists Who Stood Up

Dr. Jack Henningfield, Dr. Chris McCurdy, Dr. Oliver Grundmann, Dr. Marc Swogger, Dr. Paula Brown, and Dr. Walter Prozialek.

Politicians Who Stood Up

Former Rep. Matt Salmon (R-AZ), Rep. Mark Pocan (D-WI), Sen. Corey Booker (D-NJ), Rep. Jared Polis (D-CO) and now Governor of Colorado, and posthumously,  Sen. Orrin G. Hatch (R-UT).

Industry Leaders Who Stood Up

Sebastian Guthrie, Steve Curtis, Sean and Megan Zamorano, Matt and Melissa Frank, David Derian, Duncan McRae, Dan Bower, Derek Connors, Chris Fiumara, Elizabeth Gardner, Jordan Richard, Keith Pascucci, Kelly Dunn, Jessica Gerding, Lynette Gryniak, Shawn Brady, and Dalton Locke.

Advocates Who Stood Up

Brian Gallagher, Mike Overstreet, Drew Turner, Melody Woolf, Kami Davis, Misty Brown, Kelly Devine, Dijon Evans, Heidi Sykora, Ila Webster, Elizabeth Gardner, Nick Bauer, Kyle Waldron, Angela Watson, Travis Lowen, Vernon Jones, and Lisha Adcock.

Original AKA Board of Directors Who Stood Up

Susan Ash, Paul Kemp, Angela Ross, Robin Graham, and William Robin,

Click here to watch the full webinar.

Latest Keep Kratom Safe Webinar: War on Georgia H.B 181 and Legacy Hall of Fame Addendums

 

We are excited to add several names to our Legacy Hall of Fame. Without the efforts and vision of these early advocates, kratom access in the United States would look very different today. We are honored to include them in this recognition:

Kelly Devine, Angela Watson, Travis Lowen, Bernie Jones, Jared Polis, Kelly Dunn, and Jordan Richard

Georgia Representative Rick Townsend, with trial attorneys in tow, misrepresented the American Kratom Association’s position on H.B. 181 in a backdoor negotiation with the Senate Health and Human Services committee, the Chairman, and the Chairman of the Rules Committee. Townsend claimed that the AKA was supportive of the bill, implying we were comfortable with the amendments that were recently made by Townsend. With this understanding, the committee did not allow the AKA to testify in the latest hearing. However, while we supported H.B. 181, as it was negotiated previously, we have never supported the newly made amendments. They over-criminalize kratom processors and retailers with penalties disproportionate to kratom’s safety profile. They could create a chilling effect on anyone either manufacturing or selling kratom and therefore negatively impact consumers’ access to it.

It is likely the bill with the amendments will pass in Georgia’s Senate. However, it will need to reappear in the House for vote on these amendments.  We hope the Georgia House will amend the bill to reduce the severity of criminal penalties on retailers.

Click here to watch the full webinar

Kratom’s Role in Overdose Deaths is Misunderstood

Fox News recently reported that kratom has been credited with 1.5% to 1.7% of overdose deaths between Jan. 2020 and Dec. 2022. Lori Karan, M.D., professor of internal and preventive medicine at Loma Linda University, reported though that most of these cases involved other substances. Many included fentanyl, and yet, kratom is still listed as contributory in the death.

There is no known lethal dose of kratom so it is erroneous of medical examiners to make such a claim. Even the FDA cannot place the full blame on kratom as they have stated on their website, “the contribution of kratom in the deaths is unclear.” Yet,  medical examiners are pronouncing kratom as a contributory or even sole cause of overdose deaths.

There is too much variability in testing and reporting, according to Cornel N. Stanciu, M.D., director of addiction services at New Hampshire Hospital and assistant professor of psychiatry at Geisel School of Medicine at Dartmouth. Stanciu expresses concern not only over the lack of rigorous and comprehensive testing, but also medical examiners’ readiness to declare kratom as cause of death, even when there are more lethal substances discovered.

Cities, counties, and even states are reading news reports that increasingly list kratom as a cause of overdose and, in several cases, have rushed rashly and negligently towards a kratom ban.  We know these kratom-only deaths are inflated by unsophisticated testing measures and biased reporting by the medical examiners under the influence of the FDA’s long standing bias against kratom. Their long-held public stance is that kratom is dangerous to the American public. However, the FDA knows that they can not back this statement with science or evidence. When  instructed to appear before a California judge to attest to their position against kratom, they would not because they could not. Based on their own dose finding study that determined that kratom caused no significant adverse effect, even at the high dose of 12 grams, kratom does not appear to be the risk to public safety they once accused it of being.

Click here to read the full article