Lawmakers demand FDA action on 7-OH

Two U.S. lawmakers have sent a letter to the U.S. Food and Drug Administration demanding action on the proliferation of 7-OH products in the marketplace, a development they say both misleads and endangers consumers.

The Dec. 18 letter, which was addressed to FDA Commissioner Dr. Robert Califf, was penned by Reps. Rich McCormick (R-Ga.) and Jack Bergman (R-Mich.) and raises an alarm about the rise of products containing 7-hydroxymitraginine (7-OH). This is an active metabolite of one of the major alkaloids found in the leaves of kratom (Mitragyna speciosa).

The lawmakers noted that kratom finished products that contain whole leaf powders or leaf extracts contain little to no 7-OH, which has a receptor-binding affinity much higher than mitragynine itself. The binding affinity for the mu-opioid receptors (MOR) in the body is said to be like that of morphine, raising the possibility of addiction. The 7-OH products in the market have been described as “semi-synthetic,” in that the chemical structure of the molecule arises from kratom but the products themselves have been chemically synthesized.

Lawmakers said they seek clarity on kratom/7-OH issue

The lawmakers said their concern is that many consumers will confuse 7-OH products with actual kratom, which could put them in danger. Indeed, many marketers of 7-OH products use the word “kratom” in their messaging.

Related:Kratom experts raise 7-OH alarm — again

“7-hydroxymitragynine products are synthetically altered to increase their potency and have no safety data to support their use,” the lawmakers noted.

“Consumers unfamiliar with kratom risk purchasing and ingesting a product with much higher potency and concentration of specific alkaloids than what a normal serving of pure leaf kratom product, for example, contains,” they added.

The lawmakers requested that FDA respond about four specific points:

Misreporting of adverse events

The lawmakers’ letter referenced a recent letter to the editor published in the journal Addiction penned by experts from Johns Hopkins University, the Ohio State University and the University of Florida in Gainesville. 

The experts said that while the pharmacology and safety profiles of kratom leaf powders and extracts are relatively well known, the same can’t be said for 7-OH. Also, the experts noted, any adverse events that may arise from the use of 7-OH products likely will erroneously be attributed to kratom, when in fact they should be viewed as separate categories of products.

Related:Kratom groups, researchers sound alarm over 7-hydroxymitragynine products

‘Comprehensive response’ sought

McCormick and Bergman said they believed “a comprehensive response” to their questions is “essential to ensure the safety and well-being of consumers.” They gave no deadline for their request, except to say they expected a “prompt” response.

Because of the holiday, FDA was not able to provide a response to a request for comment.

The Global Kratom Coalition said it supported the lawmakers’ request for information from FDA, and said it is working to get the word out about the issues surrounding 7-OH via efforts such as the Kratom Consumer Advisory Board.

Matthew Lowe, executive director of the Global Kratom Coalition, had this to say: “Legislators are rightfully concerned over the proliferation of products containing artificially elevated levels of synthetic 7-hydroxymitragynine. These substances, commonly called ‘7,’ are rapidly infiltrating the marketplace, posing a significant public health concern. With at least eight new chemical entities, no established history of safe use, and an absence of clinical data to substantiate their intended use, ‘7’ is being unlawfully marketed as a treatment for opioid use disorder and chronic pain while masquerading as a dietary supplement. This situation demands an immediate and coordinated response, with rigorous federal, state and local enforcement to uphold regulatory standards, protect public health, and combat these deceptive and illicit practices.”