FDA looks to restrict synthetic opioids sold at gas stations

The Food and Drug Administration is looking to crack down on a synthetic opioid product that Commissioner Marty Makary describes as “more potent than morphine.” The product is now readily available at gas stations, convenience stores and vape shops across the country.

Marketed as energy supplements derived from the kratom plant, the FDA wants to classify products containing 7-hydroxymitragynine, or 7-OH, as drugs regulated under the Controlled Substances Act.

What is 7-OH?

In a press release, the FDA said it’s specifically targeting the 7-OH concentrated byproduct of the kratom plant. The agency says it is “increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors.”

“Seven-OH is not just like an opioid,” Makary said during a press conference on July 19. “It does not just have opioid binding properties. 7-OH binds to the Mu-receptor, which means, scientifically, by definition, it is an opioid. And yet it is sold in vape stores, in smoke shops and convenience stores and gas stations that are popping up all over the United States, and nobody knows what it is.”

The FDA also released a report aimed at educating people on the difference between 7-OH kratom products and those derived only from the natural kratom leaf.

What does it mean to schedule a drug?

The government schedules drugs by listing them in one of five categories, based on their potential for abuse, acceptable medical use and likelihood of dependence.

Schedule I drugs have no accepted medical use and a high potential for abuse, according to the Drug Enforcement Administration. Examples include heroin, LSD, marijuana and ecstasy.

Schedule V includes frequently used medicines, such as Robitussin AC, that contain small amounts of codeine.

The other schedules cover drugs — some legal, some illegal — that have varying degrees of addictiveness.

Currently, the government does not regulate 7-OH products, which manufacturers widely sell in various forms, including tablets, gummies, drink mixes and shots.

The FDA raised concerns about these products because they can attract children and teenagers, especially when companies sell them as gummy candies and label them as kratom.

The FDA’s recommendation on 7-OH now goes to the DEA, which will make a final decision on whether to regulate the substance.