Guest Column
Not all kratom products are equal. That’s why we need regulation and enforcement.
The FDA should proactively enforce labeling requirements, including the list of ingredients, strength of active ingredients and recommended conditions for use. Basically, the who, what and when of supplement use.
A close-up of kratom leaves.
A close-up of kratom leaves. [ JEFFEREE WOO | Times ]
Published Feb. 1

The Tampa Bay Times’ investigative series on the herbal supplement kratom sheds necessary light on serious problems in the kratom industry that demand immediate action to protect consumers.

In full disclosure, as a scientist and longtime researcher on herbal supplements including kratom, I was interviewed along with many of my colleagues for the Times’ reporting, for which the newspaper and my fellow scientists should be commended. However, a few critical points require further explanation.

Paula Brown
Paula Brown [ Provided ]

Above all, it’s crucial to understand not all kratom products are equal and therefore should not be portrayed in the same dangerous light. The Times’ series discussed a vast array of products ranging from simple leaf, as used traditionally for hundreds of years, to extracts of various types and concentrations. This is noteworthy because when a natural ingredient’s complex chemical composition is altered, as can be the case when making highly potent kratom extracts, the nature of its effects on humans is also altered in potentially unpredictable and unsafe ways.

Paracelsus taught that “only the dose makes the poison.” Just as some vitamins and beneficial medicines can cause great harm in the wrong dosages, so too can kratom, especially when processed as highly concentrated extracts that no longer reflect the nature of the leaf’s total plant chemistry. However, when used in its natural, unaltered state at a traditional serving size, for short-term use, kratom can provide valuable benefits such as relief of minor aches and pains, alleviation of stress and elevation of mood.

Although the therapeutic potential of kratom and kratom-derived products for such indications as alleviating symptoms of opioid withdrawal appears promising, there is still much to learn about the potential risks associated with nontraditional uses. For this reason, it is important that consumers understand that the historical safety data only applies to the unaltered leaf and not all products derived from kratom leaves. Products that do not provide the conditions under which they can be safely used are misbranded under the Food Drugs and Cosmetic Act, yet the Times’ reporting demonstrated most products are improperly labeled.

The Food and Drug Administration already has regulatory oversight responsibilities for dietary supplements, including kratom, through the Dietary Supplement Health and Education Act (DSHEA), which includes regulations on dietary supplement manufacturing, health claims and labeling. While the FDA has taken some action, in particular when therapeutic drugs claims are made, stepping up enforcement in additional areas would be impactful for consumers.

As such, the FDA should proactively enforce the labeling requirements including the list of ingredients, strength of active ingredients and recommended conditions for use. Basically, the who, what and when of supplement use. Who should and should not take the product, how much product equals a serving, how many servings to take and for what duration the product can be used. They could also send warning letters to offending manufacturers and retailers carrying improperly labeled products. Further, the agency could limit the potency of active ingredients in kratom products, especially for dietary supplements made from kratom ingredients in extract form.

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Finally, it is imperative manufacturers provide clear label warnings against co-mingling with other drugs, making it clear that the consequences of doing so may cause serious harm, including death. As the Times’ series reveals, the majority of kratom-related fatalities involved the presence of other substances.

Florida lawmakers had the foresight last year to adopt minimum age restriction of kratom products rather than pursuing an outright ban which would have eliminated safe and harmful products alike. Now, state and federal agencies must use their existing regulatory authority to enforce the rules already in place to protect consumers.

Paula Brown is director of Applied Research at the British Columbia Institute of Technology and provides expert testimony and regulatory guidance as a consultant on medicinal plants including kratom.