What’s listed on a kratom product label may not tell the full story. Researchers in the University of Florida College of Pharmacy have found that commercially available kratom products, including many kratom-derived products, contain chemical compositions that differ from their labels, highlighting gaps in product transparency and the need for stronger regulation.
The findings were released at a time when the kratom marketplace is rapidly expanding. Kratom-labeled products can be purchased as powders, tablets, gummies and concentrated liquid shots. The products are often sold as generically labeled kratom, despite being chemically and pharmacologically different from traditional leaf kratom.
Kratom, known scientifically as Mitragyna speciosa, is a plant native to Southeast Asia that has traditionally been used for stimulant and analgesic effects. The plant contains more than 40 identified alkaloids, including compounds that interact with human opioid receptors. These alkaloids vary in their chemical structures and may produce different pharmacological effects.
“Consumers should be able to trust that a product’s label accurately reflects what’s inside,” said Abhisheak Sharma, Ph.D., M.Pharm., associate chair and an assistant professor of pharmaceutics in the UF College of Pharmacy and lead author of the study published in the journal Drug Testing and Analysis. “Our findings show that stronger manufacturing standards, comprehensive testing and transparent labeling are needed to help people make informed decisions and reduce potential safety risks.”
In the study, UF researchers analyzed 44 commercially available kratom and kratom-derived products collected from online platforms and stores in multiple U.S. states. The products included kratom-labeled tablets, films, liquid shots and edibles.
Researchers compared the ingredients and concentrations listed on product labels with the chemical components detected through laboratory analysis. In 85% of the products analyzed, the measured concentrations did not align with their labeled content. In some cases, products reported a single alkaloid on their label, but multiple alkaloids were detected. Other products contained compounds that were not disclosed on the labels.
“The findings are of strong relevance to public health and underscore regulatory actions needed for proper labeling requirements by manufacturers for consumers to know what they are purchasing,” said Christopher McCurdy, Ph.D., a distinguished professor, the Frank A. Duckworth Eminent Scholar Chair and associate dean for faculty development in the UF College of Pharmacy. “Right now, consumers are part of a large experiment in which they are taking products that they believe are properly labeled as to the composition of ingredients, yet they are being deceived intentionally or unintentionally by the manufacturers, putting the public at risk.”
The findings highlight challenges in a rapidly changing kratom marketplace where limited clinical evidence and inconsistent product information can make it hard for consumers to understand potential risks and benefits. The U.S. Food and Drug Administration has issued warnings regarding misleading or unproven claims about kratom products and continues to monitor their safety.
Sharma said another challenge is the emergence of semisynthetic products that are sometimes marketed as kratom, including those containing the potent compound 7-hydroxymitragynine, or 7-OH. The FDA has issued warnings about the illegal marketing of 7-OH products and recommended scheduling them under the Controlled Substances Act due to opioid-like effects and public health risks.
“Products containing semisynthetic, kratom-derived compounds should be clearly distinguished from natural kratom products,” Sharma said. “Accurate labeling and transparent communication are essential to ensure consumers understand what they are purchasing so they can make informed decisions about their use.”