By: Megan Brooks (MedScape)

November 15, 2017

The American Kratom Association (AKA) has petitioned the US Food and Drug Administration (FDA) to “review and correct” the agency’s public health advisory on kratom.

On November 14, the FDA warned against the use of kratom, a plant with opioid properties, noting it is addictive and has been linked to 36 deaths.

The AKA, a consumer-based nonprofit organization, said the advisory is based on “discredited, incomplete, and mischaracterized scientific claims” and should be rescinded.

The organization has initiated a formal dispute resolution petition with the US Department of Health and Human Services challenging the “weak scientific basis” of the FDA advisory and seeking to have it overturned, according to a statement from the organization.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA [Drug Enforcement Administration], 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 reads.

Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. Its popularity is increasing in the United States, with users claiming the botanical helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.

But it is an unapproved drug and is being illegally promoted for those conditions, FDA Commissioner Scott Gottlieb, MD, said in the public health advisory. He added that current evidence shows that kratom “has similar effects to narcotics like opioids and carries similar risks of abuse, addiction, and in some cases, death.”

A “Handful of Possible Deaths”

The AKA disagrees, stating that, contrary to the statement that kratom has narcotic opioid like abuse potential and other effects, kratom is primarily used by millions of Americans not to get “high” but because it is beneficial.

The organization says it is “well documented” that kratom does not cause the lethal respiratory depressing effects that are a hallmark of narcoticlike opioids. “In stark contrast, among millions of users of kratom in America, probably dating back to the 1990s and earlier, there has not been a single documented actual kratom-caused overdose death.

“The handful of possible kratom-associated deaths in the US involved people taking multiple drugs, with apparent causes of death varying widely, quite unlike what is seen with narcoticlike opioids,” the AKA said.

“We care very much about the health and well-being of the kratom community and that is why we welcome a full-scale review and the eventual rescinding of the FDA’s latest attack on kratom,” said AKA President and Board Chair Dave Herman.

“We know from surveys that kratom consumers are concerned about being forced to seek relief by using illegal opioids in the event that kratom is banned. It would be an outrageous and unacceptable public health outcome if the effect of the FDA assault on kratom backfires and leads to more opioid addiction and death.

“The very real possibility of this kind of unintended consequence happening in the wake of FDA-inspired restrictions on kratom should give any responsible legislator or regulator real pause,” Herman stated.

The AKA’s petition is available online.