AKA filed the formal demand late Wednesday, after the release of Gottlieb’s statement. Gottlieb had warned about the ‘deadly risks’ associated with kratom and said the agency “must use its authority to protect the public from addictive substances like kratom..”
Gottlieb voiced his grave concerns about the use of the botanical. In the agency’s view, the botanical has no reliable safety data on file, and most of the assertions of safe use from proponents such as the American Kratom Association are based on anecdotal reports.
Lack of safety data
“Proponents argue that it’s a safe substance largely because it’s a plant-based product,” Gottlieb said. “Evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death.”
Among the safety issues associated with the botanical, Gottlieb cited a rising tide of reports to poison control centers connected with the botanical. “Calls to US poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms,” Gottlieb said.
AKA: ‘Discredited, mischaracterized claims’
In response, AKA said Gottlieb’s warning was based on “discredited, incomplete, and mischaracterized scientific claims” and should be rescinded. The organization has initiated a formal dispute resolution (FDR) petition with the U.S. Department of Health and Human Services (HHS) challenging what it calls the weak scientific basis of the FDA advisory and seeking to have it overturned. AKA maintains that more than three million consumers in North America regularly use kratom without adverse events.
AKA advocates for access to kratom without particular reference to its regulatory positioning. FDA has imposed import alerts on the substance in 2012 and again in 2014 and has seized almost $5 million worth of kratom in the years since.
“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities. AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims,”the statement from AKA said.
Cause for concern
Rick Kingson, PharmD, is president of scientific and regulatory affairs with the consulting firm SafetyCall International and is an expert on adverse event reporting and the parsing of data from poison control centers. Kingston, who is also a professor in the school of pharmacy at the University of Minnesota, said FDA now has access directly to raw data from poison control centers, which makes corroborating or refuting Gottlieb’s citations of that data difficult.
“The only way you could tell if calls to poison control centers were increasing would be to get access to their proprietary data (which FDA now has) as kratom does not have its own listing in the annual report and is likely aggregated under the general title of botanical. His statement is a little cryptic though. He now has access to data indicating that calls to PCs involving kratom are up. What he doesn’t say is what those calls entail and the medical outcomes. His sentence regarding they are aware of 36 deaths is likely not connected to PC data as I could find no data in PC publicly available annual reports to support this. Thus, FDA is getting those fatality numbers from somewhere else," he said.
Still, Kingston said the numbers very well could signal a cause for concern.
“What really needs to be pointed out here is that 36 deaths potentially associated with any substance is a huge red flag. Further, the fact that there are relatively few cases reported anywhere but a relatively large number are serious is another red flag. It means there is no effective surveillance system in place. You could possibly explain some of those deaths as potentially being unrelated if they had a huge market penetration and numerous minor effect cases were being seen. In that case some of the more serious events might fall into the background noise. I just don’t think that’s the case here,” he said.
NDI notification would be first step
Natural Products Association president Dr Dan Fabricant, PhD, was no fan of kratom during his time as head of the Division (now Office) of Dietary Supplement Programs at FDA. He has said in the past that the marketers of kratom ingredients ought to go through the New Dietary Ingredient Notification process if they wanted to attempt to bring the botanical to market legally, though even that route now looks closed after Gottlieb said the botanical really ought to be developed as a drug.
“We’re supportive of the message from Commissioner Gottlieb on kratom, especially as it pertains to those selling products masquerading as dietary supplements with disease claims that can delay treatment and cause real public health problems,” he said.