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The US Food and Drug Administration (FDA) has issued seven warning letters to companies accused of illegally selling products containing 7-hydroxymitragynine (7-OH), a substance also referred to as synthetic Kratom.
These companies, based in California, Florida and Texas, are accused of marketing synthetic 7-OH products through online platforms, gas stations, smoke shops and convenience stores. The FDA expressed increasing concern over “novel, potent opioid products” entering the market and potentially putting public health at risk.
The warning letters focus on products that either contain added 7-OH or have elevated levels of the compound. According to the FDA:
Dr. Daniel Fabricant, PhD, president and CEO of the Natural Products Association, supported the FDA’s move. He said: “These 7-OH products are not legitimate ‘dietary supplements’ and NPA encourages FDA in collaboration with the U.S. Department of Justice to take any necessary steps to swiftly remove them from U.S. commerce.”
Robert Durkin, partner at law firm Amin Wasserman Gurnani and co-chair of its regulatory group, questioned the delay in action: “Even in the 7-OH warning letters, FDA mention Kratom. Fact is, 7-OH is not Kratom... Saying 7-OH is Kratom is like saying if someone took coffee beans, brewed a pot of coffee, extracted the caffeine, converted it into something else and then called it coffee.”
The FDA flagged concentrated forms of 7-OH, including:
One letter was addressed to the CEO of Kansas City-based Shaman Botanicals, citing illegal marketing of 7-OK branded products. The letter stated: “Your product labeling... declares 7-hydroxymitragynine (7-OH) as an ingredient... introducing or delivering these products... violates the Federal Food, Drug and Cosmetic Act.”
Other companies receiving warnings include:
The FDA also previously warned Hydroxie, LLC for marketing its 7-OH drink mix as a dietary supplement. The agency found:
Examples of user testimonials included relief from fibromyalgia, multiple sclerosis, and chronic pain.
Jeff Smith, national policy director for the nonprofit HART, argued that the focus should be on responsible regulation: “We are not asking the FDA to take our word for it. We are asking the agency to consider the data.”
According to HART:
Smith added: “Emerging data strongly suggests that 7-OH, when produced and used responsibly, has a significantly lower risk profile than many Kratom products that are not being targeted by the FDA.”
While 7-OH is found in trace amounts in natural Kratom leaves from Southeast Asia, synthetic forms are much more potent. According to Paula Brown, director at BCIT’s Natural Health and Food Products Research Group:
Matthew Lowe, executive director of the Kratom Coalition, applauded the crackdown: “There’s been a slew of consumer issues... people being tricked into thinking it’s natural Kratom, developing intense addictions... it’s always been our contention that these products have been unapproved drugs.”
Dr Sibyl Swift, PhD, chief science officer at Johnson Foods, echoed the sentiment: “These products are derived from synthetic processes with no benefit and a tremendous potential to harm consumers. FDA’s actions are a welcome step toward protecting consumers.”
The companies named in the warning letters have 15 days to respond and address the alleged violations. As the FDA intensifies its oversight, debate continues over how best to regulate synthetic substances masquerading as natural supplements.
