FDA cautions against dangerous opioid sold at gas stations

The Food and Drug Administration is warning about a concentrated opioid being sold in gas stations and vape shops nationwide.

FDA Commissioner Dr. Marty Makary said the agency wants to get ahead of what could be a new wave of the opioid crisis.

“We can’t get caught flat-footed again,” Makary told reporters. “We got burned with fentanyl, we got burned with prescription drugs. We cannot get behind the eightball again. This may be the fourth wave of the opioid epidemic. Concentrated, synthetic, 7-OH may be the fourth wave of the opioid epidemic.”

The drug, a highly concentrated kratom compound – 7-hydroxymitragynine – is up to 13 times more potent than morphine, according to Makary.

“7-OH, people need to know, is an opioid,” he said. “You can walk down the street in almost any neighborhood in America and buy an opioid.”

The FDA said it is not targeting the natural kratom leaf, which comes from Southeast Asia. Instead, it wants to combat synthetic and concentrated 7-OH.

At the end of July, the FDA recommended classifying 7-OH as a Schedule I controlled substance. This would make it illegal to sell or possess.

The federal agency cites numerous health risks, including addiction and overdose. People consume it in powders, pills, vapes, drinks, gummies and even ice cream cones.

No federal age restriction currently exists on these products; some states ban sales to minors or limit concentrations.

The CDC has detected overdose deaths linked to kratom, though other drugs were often present.

Dr. Alicia Tudor, a toxicologist and emergency physician at Albany Medical Center, believes kratom overdoses are underreported.

“I’ll see it in the emergency department and then probably more often in the addiction clinic that I work at as well,” Tudor told WRGB.

New York mother Cari Scribner lost her son Nickolas last year. She said her son thought kratom was “all natural.”

Makary also read a letter from a stepfather whose son died after taking two 20 mg 7-OH pills bought at a vape shop.

“He said that he took the pill and became addicted, and should have done his research,” Makary said. “He died the night he took two 20 mg 7-OH pills. The wrapper was at his bedside. There were no other drugs or alcohol in the house.”

Florida recently made 7-OH a Schedule I substance. Ohio Gov. Mike DeWine has urged action, and the U.S. Drug Enforcement Administration (DEA) is reviewing the FDA recommendation.