FDA and HHS Warn of Easy Access to Addictive Kratom Byproduct 7-OH

New Federal Efforts to Combat a Dangerous Opioid

The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) are taking new steps to address a growing concern: a dangerous opioid known as 7-OH. This substance, derived from the kratom plant, is currently found in products sold at gas stations and smoke shops across the country. The FDA has identified 7-OH as a significant public health threat due to its ability to bind to opioid receptors in the human body, raising alarms about its potential for abuse and harm.

Health and Human Services Secretary RFK Jr. emphasized the urgency of the situation during a press conference on Tuesday, stating that the U.S. cannot afford to be unprepared for another opioid crisis. "These products are marketed to children. They come in gummy bear shapes, bright colors, and candy flavors... We need to wake up and stop this before it starts."

Pharmacist Jacob Standefer expressed shock at the ease with which 7-OH is being sold, especially since it is often labeled as a supplement despite its potent opioid-like effects. "This is a public health emergency," he said. 7-OH, or 7-hydroxymitragynine, is a chemical extract of kratom, a plant traditionally used for pain relief. However, experts warn that these products should not be available over the counter at gas stations or online. "There's no use for them," Standefer added.

Federal health leaders have urged the Drug Enforcement Administration (DEA) to classify 7-OH as a Schedule I drug, the same category as heroin. Deputy Secretary Jim O’Neill highlighted the potency of the substance, noting that it is 13 times more powerful than morphine. This classification would make it illegal to possess or distribute without a license, significantly limiting access.

Despite these concerns, 7-OH continues to be sold openly in various retail locations. Products containing the substance often boast high potency and appealing flavors, making them particularly attractive to younger consumers. Senator Markwayne Mullin pointed out that those selling these products are well aware of their effects and who they are targeting. "They're selling it as a dietary supplement," he said, emphasizing the misleading marketing tactics used to attract buyers.

The confusion surrounding 7-OH has led to real-world consequences. Melody Wolf, a woman who turned to kratom for pain relief, shared her experience after being handed a 7-OH product by a seller. "I told him that wasn’t kratom, and he was confused," she said. This highlights the risks associated with the lack of transparency in labeling and the potential for misuse.

In Chattanooga, the Center for Addiction and Recovery (CADAS) has reported an increase in kratom-related cases, likely involving 7-OH. A spokesperson for CADAS stated, "One of the biggest concerns is how readily it can be obtained and how the end user may or may not know what's in the product they're buying." This lack of awareness poses a serious risk to public health.

Standefer and other health experts argue that 7-OH should be removed from store shelves until further research is conducted. "We need to get this product banned right off the bat until there's some studies or something that shows that it's beneficial," he said. The push for regulation comes as a class-action lawsuit against a company that sells a product containing 7-OH, called Feel Free Wellness Tonic, recently concluded with a $8.75 million settlement. The company, Botanic Tonics, agreed to pay the fine after being accused of failing to disclose the presence of a kratom by-product in its product.

Local law enforcement officials have acknowledged the presence of 7-OH in the community, but Hamilton County District Attorney Coty Wamp noted that her office has not yet received any specific cases involving the substance. "To my knowledge, my office has not been presented with an investigation involving this opioid," she said. However, the ongoing efforts by federal agencies suggest that the issue is far from resolved.

As the debate over 7-OH continues, the focus remains on protecting public health and preventing another wave of opioid-related harm. With its increasing availability and potent effects, the need for strict regulation and consumer education has never been more urgent.