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The U.S. Food and Drug Administration (FDA) <a href="https://www.hhs.gov/press-room/fda-7-oh-scheduling-recommendation.html#:~:text=In%20June%2C%20the%20FDA%20issued,any%20scheduling%20action%20is%20finalized.&text=The%20FDA%2C%20an%20agency%20within,and%20for%20regulating%20tobacco%20products">announced</a> action to restrict access to 7-hydroxymitragynine (7-OH), a potent and highly addictive opioid compound derived from the kratom plant. The federal crackdown comes amid growing concern over the presence of concentrated and unregulated 7-OH products sold in gas stations, vape stores, and online marketplaces across the country.

Deputy Secretary O’Neill issued a warning at the <a href="https://www.ntd.com/live-now-hhs-fda-and-sen-mullin-to-announce-action-on-opioid-7-oh_1081676.html">press conference</a> on July 29. “Not all innovation is positive,” he said. “Dark innovation has exacerbated the addiction crisis in this country with synthetic opioids like carfentanil, and now 7-OH.”

“It’s a highly addictive substance, many times more powerful than morphine. We’ve seen a disturbing rise in overdoses, poisonings, and ER visits tied to these products. They’re often sold with no dosage guidance, no warnings, and no quality control,” said O’Neil.

The press conference was hosted by Health and Human Services Secretary Robert F. Kennedy Jr., Deputy Secretary Jim O’Neill, FDA Commissioner Dr. Marty Makary, and Sen. Markwayne Mullin (R-Okla.) in Washington.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said Makary in a <a href="https://www.hhs.gov/press-room/fda-7-oh-scheduling-recommendation.html#:~:text=In%20June%2C%20the%20FDA%20issued,any%20scheduling%20action%20is%20finalized.&text=The%20FDA%2C%20an%20agency%20within,and%20for%20regulating%20tobacco%20products">press release</a> also on July 29. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

The FDA recommended that 7-OH be classified as a controlled substance under the Controlled Substances Act (CSA). The agency discovered that 7-OH is being extracted and sold in high concentrations in the form of gummies, tablets, shots, and drink powders.

Kratom capsules in Albany, N.Y., on Sept. 27, 2017. (Mary Esch/AP Photo)

At the press conference, Makary said that over 85 percent of the vape products are illegal.

Earlier this month, the FDA issued <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine">warning letters</a> to seven companies marketing illegal 7-OH products, including Shaman Botanicals, My Smoke Wholesale, Relax Relief Rejuvenate Trading, Thang Botanicals, Royal Diamond Imports, Hydroxie, and 7Tabz Retail. The agency cited violations ranging from selling unapproved drugs to marketing adulterated dietary supplements.

"The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones," <a href="https://www.hhs.gov/press-room/fda-7-oh-scheduling-recommendation.html#:~:text=In%20June%2C%20the%20FDA%20issued,any%20scheduling%20action%20is%20finalized.&text=The%20FDA%2C%20an%20agency%20within,and%20for%20regulating%20tobacco%20products">according</a> to the press release. "These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom."

“7-OH (formally known as 7-Hydroxymitragynine) is a powerful psychoactive compound that occurs naturally in very small amounts in the Kratom plant. 7-OH products are concentrated derivatives often falsely marketed as Kratom. Street names include 7-Hydroxy, 7-OHMG and ‘7’,” <a href="https://www.fda.gov/drugs/information-consumers-and-patients-drugs/hiding-plain-sight-7-oh-products">according</a> to the FDA.

The Drug Enforcement Administration (DEA) is now reviewing the FDA’s recommendation. If approved, 7-OH would be formally scheduled, making its distribution and sale subject to strict federal regulation. The FDA has also launched an education campaign to raise public awareness about 7-OH dangers.

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FDA Moves to Restrict Opioids Derived From Kratom Plant to Prevent Drug Epidemic

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