In a warning released last week, FDA announced that it had tested 26 kratom products obtained as a result of a recent multi state salmonella outbreak associated with the botanical. The tests on those products revealed high levels of lead and nickel that exceed safe limits for human consumption.
Chronic use concern
“While the levels of the specific products we’ve tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning. We are concerned that there may be other kratom products on the market that also contain heavy metals,” the agency wrote.
Kratom (Mitragyna speciosa), an herb that is a member of the coffee family, has a long history of use in Southeast Asia where it is native and has been gaining in prominence in the United States in recent years. The botanical’s popularity is based on its purported analgesic effects and a growing belief in its utility in helping prescription opioid abusers beat their addictions.
But the herb has risen on the enforcement radar, too, and concerns about its abuse potential in its own right caused FDA to slap an import ban on the substance in 2014.
Prior to the salmonella episode, FDA had seized kratom products on three separate occasions. The total value of the products seized totaled more than $5.5 million.
Source of contamination unclear
It’s unclear where the heavy metal content of the products tested by FDA is coming from. It’s well know that botanicals can concentrate, or bioaccumulate, metals from the soil in their tissues. Uncontrolled burning of waste in Asian cities, smog from vehicle exhausts or poorly regulated power plant or other industrial emissions could be creating a deposition problem in the areas where the raw material for these products is sourced.
Opioid withdrawal treatment claims
FDA has been mainly concerned with the use of kratom to aid in opioid withdrawal which it deems to be an illegal disease treatment claim. Earlier this year the agency issued three warning letters to companies marketing kratom for opioid withdrawal. In September, FDA Commissioner Scott Gottlieb, MD, issued a public statement on the situation that coincided with two additional warning letters.
Gottlieb has said on several occasions that kratom marketers should submit NDI Notifications on the botanical if they want to market it as a dietary supplement. The agency has said repeatedly that there is insufficient safety information available on the substance.
“The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance, and concern for the health and safety of Americans using it. To date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs,” the agency wrote in the most recent warning.
Last week, the American Kratom Association said that it had sent a letter to FDA asking the agency to reconsider its position that kratom has an abuse potential all its own. In response to the salmonella affair, AKA announced that it instituted a GMP standards program for its members.