> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Professor Blasts FDA on Harmful Supplements
- URL: https://www.fdaweb.com/professor-blasts-fda-on-harmful-supplements/
- Published: 2024-02-14T12:00:00.000Z
- Updated: 2026-09-14T14:23:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156355

Harvard Medical School assistant professor of medicine **Peter Cohen** says FDA is not doing all it could to keep harmful products sold as dietary supplements out of the hands of consumers. Interviewed 2/13 on the *PBS News Hour*, Cohen specifically [referenced](https://www.pbs.org/newshour/show/fda-warns-addictive-gas-station-heroin-supplement-widely-available-in-u-s?ref=fdaweb.com) tianeptine, commonly known as “gas station heroin” and sold as Neptune’s Fix.

The agency issued a 1/23 [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-product-due-serious-risks?ref=fdaweb.com) on the product, saying it “continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness, and death.” FDA also announced the manufacturer is undertaking a recall of the products.

However, Cohen pointed out that this was the latest of several statements FDA has issued in the years since tianeptine, a foreign antidepressant that is not approved for any use in the U.S., entered the country in 2015\. The agency’s first warning was in 2018, he said.

Asked how such an unapproved drug can still be sold in the U.S., Cohen responded that “what we see as a common and, sadly, tragic pattern is that many companies take foreign drugs and introduce them directly to consumers in the United States by selling them as if they were dietary supplements.”

Cohen said he sees two regulatory problems — how such a drug can get on the market in the first place, and why all FDA has done since 2018 is issue written statements.

Asked if FDA has been negligent, Cohen said preventing the arrival of tianeptine in the country would require Congress to change the law to authorize FDA to vet dietary supplements. “However,” he continued, “the fact that it’s still sold today and that people are still dying and ending up in intensive care units due to tianeptine falls completely on FDA not doing their part, ensuring that dangerous supplements are removed from the marketplace.”

He suggested that Congress could **(1)** ask FDA to enforce the law and remove dangerous supplements and **(2)** change the law to authorize the agency to ensure that products that are introduced into the United States as dietary supplements are not dangerous foreign drugs. He said kratom and phenibut are two other drugs being sold as dietary supplements but shouldn’t be and “FDA is not doing enough to get these products off store shelves.”

Cohen said researchers looked at what happened to brands of phenibut before and after FDA warnings and found that dosages increased after the agency’s statements. “So FDA’s actions are inadequate to date, and they need to do a lot more, because it’s not just these three products … but more than a dozen other foreign drugs that are being sold currently as dietary supplements in the U.S.,” he concluded.