FDA Urges Justice Department to Label Gas Station Products with Opioid-Like Effects as Illegal: What You Need to Know

The FDA has suggested classifying a compound called 7-hydroxymitragynine (7-OH) as an illegal substance. Found in unregulated products like gummies and drinks sold at gas stations, 7-OH has opioid-like effects. It’s marketed for relaxation, pain relief, and improved focus. However, studies indicate it could be more potent than morphine and pose serious health risks, including potential heart or liver damage and even death.

Jim O’Neill, from the U.S. Department of Health and Human Services, pointed out a troubling rise in overdoses and emergency room visits related to 7-OH products. He emphasized that these products often come without warning labels about their risks or quality control. “This is a recipe for disaster,” he warned.

7-OH occurs naturally in kratom leaves, which have been sold as a dietary supplement without regulation. While kratom contains low levels of 7-OH, products explicitly labeled as 7-OH typically contain concentrated, synthetic forms. The FDA has observed that some of these products are misleadingly marketed as being derived from kratom.

Following the FDA’s recommendation, the Drug Enforcement Administration (DEA) will review how to classify 7-OH, with the possibility of placing it in a Schedule I category, similar to heroin and marijuana, indicating a high potential for abuse with no accepted medical use.

In 2022, about 1.9 million Americans aged 12 and older reported using kratom, according to the National Survey on Drug Use and Health. Health officials, including Secretary of Health and Human Services Robert F. Kennedy Jr., have highlighted the prevalence of 7-OH products near schools and in vulnerable communities. He noted that these products are marketed in ways appealing to children, resembling gummies and brightly colored candies, which raises ethical concerns about the industry.

Experts have voiced differing opinions. Some argue that while 7-OH is dangerous, kratom itself can help manage pain and may assist individuals recovering from stronger opioids. The American Kratom Association has expressed willingness for regulation but maintains that kratom should not be categorized as a highly abusive substance.

The FDA issued warning letters in June to companies illegally marketing 7-OH products. They emphasized that these substances cannot be safely added to food or supplements due to insufficient safety data. Currently, the responsibility is on companies to test for safety, but enforcement is challenging.

As the discussion continues, it’s clear that balancing public health and access to alternative treatments is a complex issue, drawing varied reactions from both health advocates and users.



Source link