All around the nation, in late 2017 and early 2018, alarm bells were going off relating to a drug referred to as tianeptine. In Michigan, lawmakers sought to ban gross sales of the drug, which has opioidlike effects, after stories that users became 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 at the time was also trying into the dangers of tianeptine, which is used as a dietary complement ingredient despite being illegal. However the company-which regulates medicine and supplements in the U.S.-waited no less than nine months to alert the public in regards to the risks. A current investigation by CR found significant shortcomings with the agency’s enforcement efforts around tianeptine. The new emails, obtained via the freedom of information Act, underscore issues about the FDA’s skill to effectively police the $46 billion dietary complement business.

"When there are blatant examples of illicit medicine being bought as supplements, significantly medication that are known to be dangerous, we have to have an agency that’s proactive," says Pieter Cohen, MD, a Harvard Medical School affiliate professor who studies dietary supplements. Tianeptine appears to have arrived within the U.S. 2010s, when opioid-disaster crackdowns on fentanyl and oxycodone drove people to hunt cheaper and simpler-to-come-by alternate options. Not less than four individuals have died using it, CR’s report discovered. It remains available for sale on-line to at the present time. The FDA denies dragging its feet, citing as an alternative its intensive evaluate course of. The company must analyze the ingredient, do a market survey, and gather documentation of hurt, says Courtney Rhodes, an FDA spokesperson. "Those things take time, especially when completed in the context of limited resources and competing priorities," she says. But well being specialists, client advocates, and supplement industry groups say the FDA had slam-dunk proof of hurt and illegality and will have introduced enforcement motion against tianeptine manufacturers much sooner. "It’s not a resource problem," says Daniel Fabricant, PhD, president of the Natural Products Association, a supplements trade group, and a former director of the FDA’s supplements division.

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Pub: 15 Sep 2025 20:29 UTC

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