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# Months for FDA to Warn About Tianeptine: Consumer Reports
- URL: https://www.fdaweb.com/months-for-fda-to-warn-about-tianeptine-consumer-reports/
- Published: 2021-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:48:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148746

A *Consumer Reports* (CR) investigation shows that FDA waited nine months in 2018 before warning the U.S. public about tianeptine, a dietary supplement that has opioid-like effects. The [report](https://www.consumerreports.org/dietary-supplements/fda-waited-9-months-to-warn-public-on-tianeptine-supplement-worse-than-heroin/?ref=fdaweb.com) says the magazine obtained FDA e-mails that “underscore concerns about FDA’s ability to police the $46 billion dietary supplement industry.”

The agency responded that it is required to conduct an intensive review process, analyzing a suspect ingredient, doing a market survey, and collecting documentation of harm. “These things take time, especially when done in the context of limited resources and competing priorities,” said FDA spokesperson **Courtney Rhodes**.

But outside experts told CR that the agency had clear evidence of harm and illegality and should have taken prompt enforcement action. “It’s not a resource issue,” former FDA dietary supplements regulator **Daniel Fabricant**, president of the Natural Products Association, a supplements industry group, told CR. “These are easy cases.”

“When there are blatant examples of illicit drugs being sold as supplements, particularly drugs that are known to be harmful, we need to have an agency that’s proactive,” said Harvard Medical School professor **Peter Cohen**.

The report says the FDA e-mails show that when the agency began investigating tianeptine in early 2018, it appeared to be operating with little sense of urgency and failed to develop a full view of the problem.

Once the Centers for Disease Control sounded alarms in late summer 2018 about an increase in the number of poison control center calls citing tianeptine, FDA drafted Warning Letters to send to tianeptine manufacturers. But it did not issue an alert to the public or send the Warning Letters until 11/2018, CR says. It also says the effects of the agency’s actions seem to have been limited since tianeptine-related poison control calls hit a record high in 2020\. And a vendor that was warned by FDA in 2018 continues to sell tianeptine supplements.