All across the nation, in late 2017 and early 2018, alarm bells have been going off relating to a drug called tianeptine. In Michigan, lawmakers sought to ban sales of the drug, which has opioidlike results, after stories that users turned addicted. In New York, researchers found that it could lead to abuse and overdose. In Texas, a couple alleged that their son had died on account of taking the drug. Now, emails obtained by Consumer Reports reveal that the Food and Drug Administration on the time was additionally looking into the dangers of tianeptine, which is used as a dietary supplement ingredient regardless of being unlawful. However the agency-which regulates drugs and supplements within the U.S.-waited not less than nine months to alert the general public about the dangers. A recent investigation by CR discovered important shortcomings with the agency’s enforcement efforts round tianeptine. The new emails, obtained by way of the freedom of information Act, underscore issues about the FDA’s means to successfully police the $forty six billion dietary supplement business.

"When there are blatant examples of illicit medicine being bought as supplements, significantly medication which are identified to be dangerous, we need to have an agency that’s proactive," says Pieter Cohen, MD, a Harvard Medical School affiliate professor who research dietary supplements. Tianeptine seems to have arrived within the U.S. 2010s, when opioid-disaster crackdowns on fentanyl and oxycodone drove folks to seek cheaper and easier-to-come-by alternate options. Not less than four people have died using it, CR’s report discovered. It remains accessible for sale on-line to at the present time. The FDA denies dragging its ft, citing instead its intensive assessment process. The agency should analyze the ingredient, do a market survey, and collect documentation of harm, says Courtney Rhodes, an FDA spokesperson. "Those things take time, particularly when achieved in the context of limited sources and competing priorities," she says. But health experts, consumer advocates, and complement industry groups say the FDA had slam-dunk proof of harm and illegality and will have brought enforcement motion against tianeptine manufacturers much quicker. "It’s not a resource situation," says Daniel Fabricant, PhD, president of the natural support for cognition Products Association, a supplements industry group, and a former director of the FDA’s supplements division.

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Pub: 17 Sep 2025 21:42 UTC

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