The FDA sent letters to companies selling products with concentrated 7-hydroxymitragynine, which is illegal to market.

“There are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH,” the FDA said.

Kratom, made from the leaves of a tropical tree called Mitragyna speciosa that is native to Southeast Asia, contains two main ...

The FDA has issued warnings to seven companies for illegally marketing kratom-based products containing 7-OH, a compound not approved for food or supplements, citing safety concerns and unproven ...

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and ...

Some medical researchers say 7-OH products made from kratom extracts could have the potential to create addiction problems, ...

The FDA sent a warning letter to EPH Technologies, accusing it of marketing and selling unapproved drugs. The products are sold under the names Detoxoplex, Sinoplex and Migrenza, and are marketed ...

FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia. [ press release ]. Silver Springs, MD: US Food and Drug Administration; February 16, 2021.

A print advertisement of Alkermes Plc's addiction treatment, Vivitrol, is false or misleading as it omits important risk information associated with its use, the Food and Drug Administration said ...

The U.S. Food and Drug Administration on Tuesday sent warning letters to nine online networks operating a total of 53 websites to stop illegally marketing unapproved versions of opioid medications.