In a recent development, the Food and Drug Administration (FDA) has issued a new warning regarding dietary supplements containing tianeptine, commonly known as "gas station heroin". These products, including Neptune's Fix, are typically sold at gas stations, convenience stores, and online platforms. The FDA's warning comes as these supplements have been associated with serious side effects, such as seizures, loss of consciousness, and even death.

Tianeptine is an antidepressant that is approved for use in some European, Asian, and Latin American countries; however, it is not approved for use in the United States. The substance can cause adverse reactions in the nervous system, heart, and stomach. Some of these effects mimic opioid toxicity and withdrawal, according to the Centers for Disease Control and Prevention (CDC).

These tianeptine-containing products are illegally available in the U.S. as dietary supplements, often marketed by retailers as a solution to improve brain function and treat conditions such as anxiety, depression, pain, and opioid use disorder. In November, the FDA raised the alarm about serious reactions, including seizures and loss of consciousness leading to hospitalization.

The FDA is actively investigating adverse event reports in collaboration with local and state health departments. The agency emphasizes that these supplements can interact dangerously with other medications a consumer may be taking.

Dr. Pieter Cohen, an associate professor at Harvard Medical School, who studies supplement regulations, highlighted the dysfunction of the regulatory system, stating that the illegal sale of tianeptine "is testament to the broken system." Dietary supplements in the U.S. are not FDA-approved and lack agency review for safety and effectiveness.

Neptune Resources, the manufacturer of Neptune's Fix, has agreed to voluntarily recall their products, which include Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets. While it remains unclear if these products are still available on store shelves, the FDA's actions demonstrate the seriousness of the issue.

At least 12 states have already banned the sale of tianeptine, reflecting a growing awareness of the potential dangers associated with these supplements. Furthermore, the FDA has reached out to convenience stores, gas stations, and other retailers, urging them to cease the sale of Neptune's Fix and any other tianeptine-containing products.

This FDA advisory comes on the heels of calls from House lawmakers to FDA Commissioner Dr. Robert Califf, demanding stricter measures against the use of tianeptine. As the FDA grapples with limited tools to regulate the sale of dietary supplements, heightened vigilance and stricter regulations are necessary to protect consumers from potentially harmful products.

The FDA has not provided immediate comments on the current situation. However, this warning serves as a reminder for individuals to exercise caution and consult healthcare professionals before consuming any dietary supplements.