Background on Tianeptine and Regulatory Issues
Tianeptine is an antidepressant drug that has not been approved for medical use in the United States, but has gained popularity in recent years as an ingredient in some dietary supplements sold primarily at gas stations and vape shops. Often referred to as “gas station heroin,” these supplements have been linked to serious side effects including seizures and deaths.
The FDA does not regulate dietary supplements as strictly as medications, and many contain ingredients like tianeptine that have not been proven safe or effective. As reports of harm emerged, lawmakers and health experts started calling on the agency to take action against products containing tianeptine.
FDA Warning and Call for Removal from Market
On January 24th, 2023, the FDA issued a strong warning advising consumers not to purchase or use any dietary supplements containing tianeptine.
The agency cited significant safety risks, including the following statistics based on adverse event reports:
|Reported Adverse Events from Tianeptine Supplements
|Number of Cases
Due to the risk of these serious outcomes, the FDA requested that all manufacturers and distributors immediately stop selling products containing tianeptine. Retailers were also advised to remove them from shelves.
Public Health Emergency and Call for Decisive Action
In tandem with the FDA warning, a group of Congressional lawmakers sent an urgent letter demanding swift regulatory action on supplements containing tianeptine.
Citing the supplements’ addictive potential, questionable legality, and links to “significant health risks,” the legislators asked the FDA to expedite review processes and utilize enforcement mechanisms to halt further distribution or sales.
Some public health experts described the proliferation of tianeptine supplements and ensuing overdoses as a public health emergency requiring decisive intervention.
“This unregulated opioid is posing a major threat,” said Dr. Nora Volkow of the National Institute on Drug Abuse. She commended the FDA warning, but said more aggressive measures would likely be necessary.
State and Local Bans Gain Momentum
While awaiting potential federal action, some state and local governments have taken their own steps to restrict access to products containing tianeptine.
Michigan has officially classified tianeptine as a Schedule II controlled substance, joining Alabama, Arkansas, and Tennessee which previously regulated tianeptine explicitly. Numerous other states have broader analog laws that cover tianeptine based on its opioid-like effects.
Just this week, legislators in North Carolina introduced a bill to criminalize selling, delivering, or possessing tianeptine. Some cities and counties have already enacted similar restrictions through emergency orders. Public health advocates expect more states and municipalities to follow suit.
Calls for Improved Regulation of Supplement Industry
Beyond addressing this immediate public health threat, many experts argue the case further highlights the need for more careful regulation around dietary supplements in general.
While the FDA warning should limit availability of tianeptine supplements specifically, risky stimulants, research chemicals, and experimental drugs continue to make their way into supplements sold widely online or at retail stores without sufficient oversight.
Congressional committees have started holding hearings to discuss proposals for granting added supplement enforcement powers to federal agencies. Legitimate industry groups have also called for new regulations to ensure consumer safety andconfidence. Enhanced transparency around supplement testing and ingredients may emerge as another key priority.
Outlook and Expected Next Steps
In responding to the urgent risks posed by tianeptine supplements, regulators and lawmakers will likely focus first on fully removing these products from the market through various legal and administrative channels.
If this effort falls short, officials may explore placing tianeptine itself on the federal list of banned controlled substances. However additional scheduling actions could take substantial time, allowing the formulations to spread further in the absence of expedited enforcement.
In the longer term, this case will almost certainly intensify debates over supplement regulation reform in Congress. Voters and advocates concerned about safety issues will watch closely for tangible legislative progress around enhanced ingredient testing, product registration protocols, and other measures to prevent future public health threats.
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