FDA TARGETS 7-HYDROXYMITRAGYINE IN STRING OF WARNING LETTERS TO PRODUCERS

With the United States government catching up on the science surrounding kratom, advocates for the plant gained momentum after the latest warning about products masquerading as herbal supplements. 

The Food and Drug Administration (FDA) has had a tumultuous relationship with kratom, despite ongoing studies into the plant, but recently issued a warning against 7-hydroxymitragynine (7-OH), indicating that the agency is beginning to listen to the science on the difference in the active alkaloids in kratom. Although the FDA has yet to revise its position on kratom, the development of warnings against 7-OH products is a major step in a positive direction for those in favor of natural kratom products. 

In a news release that was posted on July 15, the FDA indicated that it has sent seven warning letters to companies for “illegally marketing products containing 7-hydroxymitragynine” in violation of federal regulations. All seven of the letters were included in the news release and show that the FDA is aware of the threat posed by 7-OH and the bad actors that are using the guise of ‘natural products’ to market those products in a way that could be confusing to customers. 

As states across the country continue to malign all kratom products as “gas station heroin” and bemoan the availability of products that mimic opioids, the FDA’s crackdown on 7-OH sends a clear message: 7-OH is a different product from kratom and poses a specific threat to public health. 

7-OH vs. Natural Kratom

“This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores,” said the news release. “While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.”

Although some of the letters contain the same claims that apply to kratom and kratom extracts, the majority of the issues raised by the FDA echo the research surrounding the debate of kratom vs. 7-OH. 

Four of the letters are geared toward companies that include 7-OH as either a food additive or dietary supplement, and use the same language that the FDA has used to target kratom products in the past. What is significant, however, is that the FDA makes a clear distinction between the two active alkaloids found in the kratom plant. In a letter sent to Hydroxie, LLC, the agency identified the increased risk surrounding 7-OH products. 

“Although 7-OH is a minor component of kratom, it is a more potent inducer of opioid-like effects than the primary kratom alkaloid, mitragynine, and mitragynine converts to 7-OH in the body,” the letter said. “Because of this, products containing 7-OH as an added ingredient are of particular concern because we anticipate an increased risk of adverse effects as the dose of 7-OH increases.”

Marketing 7-OH as Treatment

Beyond the companies making claims of 7-OH as a dietary supplement or food ingredient, three other letters included warnings about labeling 7-OH as a new drug and marketing potential medical benefits. These concerns centered on claims made on the product websites, in product reviews and claims made on social media about specific conditions and medical benefits of using 7-OH products. 

Some products directly claim to treat concerns such as Fibromyalgia, Osteoarthritis and the pain associated with recovery from orthopedic injuries. Other products claimed to provide direct relief for depression, anxiety and other mental health considerations. The medical claims referenced by the FDA also included claims by the companies about 7-OH’s benefits compared to mitragynine, the primary alkaloid found in natural kratom products. 

While mitragynine has been identified by researchers to be a partial agonist of the receptors affected by opioids, the FDA’s warning letter to 7Tabz Retail, LLC included a specific warning about 7-OH. 

“7-OH is known to be a potent mu-opioid agonist and has been reported to have opioid-like effects in consumers,” the letter said. “FDA is concerned about the processes used to create the enhanced concentrations of 7-OH in the marketplace, as well as the potent effects produced by these doses of 7-OH.” 

Those concerns are what caused researchers to begin sounding the alarm on 7-OH, and echo testimony from state houses across the country where the preeminent kratom researchers have made it clear that 7-OH contains a risk factor that is not associated with natural kratom products. As advocates have pushed to ban synthetic and semi-synthetic kratom alkaloids, the FDA’s letter aligns with the safety concerns that come from kratom products that have artificially elevated levels of 7-OH. 

Each of the letters gives the companies 15 days to reply to the claims made by the FDA and requires the companies to internally review their products and claims about their products. The letters also open the door for further enforcement mechanisms, should the companies fail to address concerns raised in the warning letters.