Ongoing Scrutiny Over Kratom

Ongoing Scrutiny Over Kratom:  Challenges as a Bulk Dietary Ingredient and as a Dietary Supplement

FDA recently seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom (also known as mitragyna speciosa, a tropical tree native to Southeast Asia, commonly used for its leaves). The dietary supplements, manufactured by Oklahoma-based company Botanic Tonics, LLC, are sold in liquid and capsule formulations and are marketed under the brands “Feel Free Plant Based Herbal Supplement.” On behalf of FDA, the U.S. Department of Justice filed a complaint in the U.S. District Court for the Northern District of Oklahoma, alleging that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury, and therefore, dietary supplements and bulk dietary ingredients that contain kratom are adulterated under the Federal Food, Drug and Cosmetic Act (FDCA).

There are no current FDA-approved uses for kratom, and the agency has received reports about the safety of kratom, which appears to have addictive and abusive properties by affecting the same opioid brain receptors as morphine. Kratom’s popularity has increased over the years for its use in dietary supplements and as alternatives to prescription pain relief products. However, kratom’s growth among consumers combined with concerns of its safety, effectiveness, and lack of clinical testing, has led FDA to take enforcement action against kratom. In addition to FDA-issued Import Alerts for Kratom identifying kratom as an unapproved drug and requiring automatic detention of products subject to the Import Alert (Detention Without Physical Examination or DWPE), FDA has issued warning letters to companies marketing kratom with unproven medical claims, issued a mandatory recall for kratom products due to risk of salmonella and the FDA Commissioner has issued statements on FDA’s position on kratom over the years. Examples of claims made for kratom-containing products include its use for chronic pain management, as a natural alternative to treat depression, addiction and diabetes, and for increased attention, focus and relaxation.

In addition, DEA has listed kratom as a Drug and Chemical of Concern, although it is not currently controlled under the controlled Substances Act. There may also be some state regulations or prohibitions on the use and possession of kratom.  

As a botanical that qualifies as a dietary ingredient, FDA considers kratom to be a new dietary ingredient under the FDCA, and kratom has not been the subject of a successful New Dietary Ingredient (NDI) notification due to its toxicological challenges. As a reminder, dietary ingredients may be in one of two categories: (1) a grandfathered or “old dietary ingredient”; or (2) a “new dietary ingredient” (NDI). The Dietary Supplement Health and Education Act (DSHEA) defines a NDI as “a dietary ingredient that was not marketed in the United States before October 15, 1994.” While DSHEA does not explicitly define “old dietary ingredients,” from the definition of “new dietary ingredient” it can be concluded that an old dietary ingredient is an ingredient that was marketed in the United States prior to October 15, 1994. In determining whether a specific dietary ingredient is an ODI as opposed to a NDI, a company must show that the dietary ingredient was marketed in the United States prior to October 15, 1994. If a dietary ingredient is a NDI, then a notification demonstrating its safety must be submitted to FDA at least 75 days prior to marketing.  However, if the NDI has been present in the food supply as an article used for food in a form in which the food has not been chemically altered, then it is exempt from the NDI notification requirement. 

Kratom has not been able to obtain successful NDI notification over the years, and as a result, kratom and kratom-containing dietary supplements and bulk dietary ingredients are considered adulterated.  While there are mixed feelings about the use of kratom with some supporting a ban against the ingredient altogether, and others advocating for regulation, businesses and consumers would benefit from guidance on the production, packaging and distribution of kratom to have consistency. And for now, both businesses and consumers should remain cautious in sourcing and purchasing kratom containing products, and opt instead for essential oils for stress and relaxation (sometimes a drug, sometimes a cosmetic, sometimes both or neither depending on the claims!).