General Merchandise/HBC

FDA Issues New Warning on Tianeptine

Agency urges retailers to stop selling Neptune’s Fix and any tianeptine-containing products
Neptune’s Fix
Photograph courtesy of the FDA

The Food and Drug Administration in a Jan. 11 letter urged convenience stores and gas stations to stop selling Neptune’s Fix or any products with tianeptine, commonly known as “gas station heroin.”

The FDA, which warned about products containing tianeptine in November, said it is continuing to receive reports of seizures and loss of consciousness leading to hospitalization following the use of Neptune’s Fix products.

“These products may interact, in life-threatening ways, with other medications a consumer may be taking,” the FDA said, adding that it is “actively investigating new reports in conjunction with local and state health departments.”

Fort Worth, Texas-based Neptune Resources LLC, which is the maker of Neptune’s Fix has agreed to voluntarily recall its products that include Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets, the agency said.

Tianeptine, which is not FDA-approved for any medical use is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions, the agency said.

The FDA letter, which said at least 12 states have banned the sale of tianeptine, follows an earlier request from U.S. representatives to the agency regarding tianeptine use.

U.S. Reps Jeff Jackson (D-North Carolina) and Rich McCormick (R-Georgia) led a bipartisan group of members of Congress requesting the FDA take action to address tianeptine use.

“The urgent need for FDA action on tianeptine cannot be overstated,” the members wrote in a Jan. 18 letter to FDA Commissioner Dr. Robert Califf“It is vital to support legislative or administrative initiatives that strengthen FDA oversight and provide states greater ability to protect our communities from the dangers posed by unregulated substances like tianeptine.”

Want to learn more about the general merchandise category? Check out our event CRU in Nashville Feb. 28-March 1, 2024. Sponsors can gain 15 one-to-one meetings with qualified retailers. 

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