From dafcffbe080a39235da59dbab98cc13c3400d6b6 Mon Sep 17 00:00:00 2001 From: Bettie Goloubev Date: Sun, 5 Oct 2025 23:01:44 +0000 Subject: [PATCH] Add 'The FDA Denies Dragging Its Feet' --- The-FDA-Denies-Dragging-Its-Feet.md | 5 +++++ 1 file changed, 5 insertions(+) create mode 100644 The-FDA-Denies-Dragging-Its-Feet.md diff --git a/The-FDA-Denies-Dragging-Its-Feet.md b/The-FDA-Denies-Dragging-Its-Feet.md new file mode 100644 index 0000000..f865f39 --- /dev/null +++ b/The-FDA-Denies-Dragging-Its-Feet.md @@ -0,0 +1,5 @@ +
All across the country, in late 2017 and early 2018, alarm bells had been going off regarding 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 pair alleged that their son had died because of taking the drug. Now, emails obtained by Consumer Reports reveal that the Food and Drug Administration on the time was also looking into the dangers of tianeptine, which is used as a dietary supplement ingredient regardless of being illegal. However the agency-which regulates drugs and supplements in the U.S.-waited at the least 9 months to alert the public in regards to the risks. 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 data Act, underscore considerations concerning the FDA’s capability to effectively police the $46 billion dietary complement industry.
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"When there are blatant examples of illicit medicine being bought as supplements, particularly medicine that are recognized to be harmful, we have to have an company that’s proactive," says Pieter Cohen, MD, a Harvard Medical School associate professor who studies dietary supplements. Tianeptine appears to have arrived in the U.S. 2010s, when opioid-disaster crackdowns on fentanyl and oxycodone drove folks to seek cheaper and easier-to-come-by alternatives. No less than 4 people have died utilizing it, CR’s report discovered. It stays obtainable on the market on-line to today. The FDA denies dragging its toes, citing as a substitute its intensive evaluate course of. The company should analyze the ingredient, do a market survey, and accumulate documentation of harm, says Courtney Rhodes, an FDA spokesperson. "Those issues take time, especially when completed in the context of limited assets and competing priorities," she says. But health experts, client advocates, and supplement business groups say the FDA had slam-dunk evidence of harm and illegality and will have brought enforcement action against tianeptine manufacturers a lot quicker. "It’s not a useful resource challenge," says Daniel Fabricant, PhD, president of the Natural Products Association, a supplements business group, [focus and energy booster](http://ascrew.awardspace.info/index.php?PHPSESSID=c071237d1a8d0086167fe5a885fac181&topic=22259.0) and a former director of the FDA’s supplements division.
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