Add 'The FDA Denies Dragging Its Feet'

The-FDA-Denies-Dragging-Its-Feet.md

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+<br>All around the country, in late 2017 and early 2018, alarm bells were going off regarding a drug referred to as tianeptine. In Michigan, lawmakers sought to ban sales of the drug, which has opioidlike effects, after reviews that users grew to become addicted. In New York, researchers found that it could result in abuse and overdose. In Texas, a couple alleged that their son had died as a result of taking the drug. Now, emails obtained by Consumer Reports reveal that the Food and Drug Administration at the time was additionally looking into the dangers of tianeptine, which is used as a dietary supplement ingredient despite being illegal. But the agency-which regulates drugs and supplements in the U.S.-waited no less than 9 months to alert the public about the dangers. A current investigation by CR found significant shortcomings with the agency’s enforcement efforts around tianeptine. The new emails, obtained through the freedom of information Act, underscore considerations about the FDA’s ability to effectively police the $46 billion dietary complement business.<br>
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+<br>"When there are blatant examples of illicit medicine being sold as supplements, notably medication which can be recognized to be harmful, we need to have an company that’s proactive," says Pieter Cohen, MD, a Harvard Medical School associate professor who studies dietary supplements. Tianeptine seems to have arrived in the U.S. 2010s, when opioid-disaster crackdowns on fentanyl and oxycodone drove individuals to hunt cheaper and simpler-to-come-by alternatives. At least four individuals have died utilizing it, CR’s report discovered. It remains available for sale on-line to this day. The FDA denies dragging its toes, citing instead its intensive evaluate process. The company must analyze the ingredient, do a market survey, and gather documentation of harm, says Courtney Rhodes, an FDA spokesperson. "Those things take time, particularly when executed in the context of restricted sources and competing priorities," she says. But well being experts, consumer advocates, and supplement business teams say the FDA had slam-dunk proof of hurt and illegality and will have introduced enforcement action against tianeptine manufacturers much sooner. "It’s not a useful resource subject," says Daniel Fabricant, PhD, president of the Natural Products Association, a supplements business group, and a former director of the FDA’s supplements division.<br>
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