On January 18th, House lawmakers sent a bipartisan letter to the FDA addressing the growing danger of an unregulated synthetic drug being sold at gas stations across the United States, commonly known as “gas station heroin.” Tianeptine is a drug that has similar effects as other opioids and has many adverse side effects ranging from seizures to painful withdrawal symptoms and death. A handful of southern and midwestern states have already taken legal action to ban or control the drug. Now, lawmakers are putting pressure on the FDA to investigate tianeptine and protect communities from the dangers posed by unregulated substances. Let’s get into the details.
Background
The FDA and lawmakers are concerned with the spread of an unregulated drug called tianeptine, an antidepressant legally prescribed in countries located in Asia, Europe, and Latin America but “not approved for any medical use by the FDA” in the United States. Users are attracted to the substance, believing “it’s a safer alternative to opioids like heroin and fentanyl or because they’re trying to wean themselves off other drugs.”
Even though the drug is unapproved by the FDA, it is still accessible to Americans and is often sold online or in smoke shops and gas stations –where the name “gas station heroin” stems from. It is usually marketed as a dietary supplement or mood enhancer and is “among a growing, unregulated class of potentially additive products available.”
According to a NY Times report, Kaitlyn Brown, a clinical managing director of America’s Poison Centers, stated that “[w]e have people who can get a substance that’s not well regulated, that has abuse potential and that, in high doses, can cause similar effects to opioids, leading to really harmful outcomes.”
Legal Loopholes
Nine states, including Florida, Ohio, and Michigan, have banned or severely restricted tianeptine. Back in November, the FDA issued a nationwide alert about the drug and its harmful effects –warning people not to take it and its association with overdose and deaths. Although the FDA “loosely oversees dietary supplements,” legal loopholes have allowed companies who produce products containing tianeptine to skirt labeling requirements, continuing to sell the drug as a “dietary supplement” despite the FDA stating tianeptine does not qualify as one.
A Harvard Medical School Professor, Dr. Peter Cohen, has stated that there “are now at least a dozen different products that are foreign drugs being openly marketed as a dietary supplement under the FDA’s eyes without them being able to stop the sales.” The FDA has been warning consumers of the drug and started issuing formal warnings in 2021 and 2022 “to two companies that are said were illegally marketing tianeptine products as dietary supplements and unapproved drugs.”
According to the NY Times, regulators disagree about how the FDA should handle the rise of tianeptine and other illegal supplements. Some argue that the agency needs to establish “a strict registry of approved supplements.” Others say that getting tianeptine out of stores would be a “staggering task” –especially when people can turn to the internet and continue to buy them online.
Lawmakers Address FDA in Letter Concerning Tianeptine
The use of tianeptine is on the rise in the United States, and lawmakers are growing increasingly concerned. In 2013, “only four cases of tianeptine exposure were reported nationwide. In 2023, 391 cases were reported, according to America’s Poison Centers. New Jersey, which typically has one report a year, received 27 in 2023, with patients ranging in age from 20 to 69.”
On January 18th, five members of Congress, led by Reps. Jeff Jackson and Rich McCormick sent a bipartisan letter to the FDA asking the agency what its plans are to combat the use of tianeptine. The letter expresses concern about the growing rate at which the drug is being sold in the United States and illegally marketed as a dietary supplement. It asks the FDA to take “immediate action to research and provide guidance on tianeptine use.”
Though the FDA has issued a series of warnings concerning the use of tianeptine, the letter from Congress asks the agency to go a step further, stating, “While we appreciate these warnings, we believe more action on tianeptine use is needed to ensure the health and wellbeing of the American people.” The letter asks the FDA to answer a series of questions, including what research the agency is doing to determine the effects of regular usage of the drug and what steps the FDA plans to take with other agencies, such as the DEA, to research whether tianeptine should be scheduled under the Controlled Substance Act. The FDA told reporters from Vice News that “the FDA has received the letter and will respond directly to the member(s) of Congress.”
Wider Implications
Tianeptine is not the only unregulated substance that’s negatively impacting communities across the United States. A similar drug that is wreaking havoc is called kratom. Like tianeptine, it has additive and dangerous side effects and has caused overdoses and deaths. It is a plant-derived substance sometimes mixed with synthetic pharmaceuticals and sold as a powder or pill and marketed to the public as a supplement.
An investigation by the Tampa Times reported that “more than 580 people in Florida have died from kratom-related overdoses in the past decade –even as the industry has touted the safety of its products. Most of the deaths were caused by a fatal mixture of the kratom and at least one other substance, but 46 people overdosed solely on the herb.”
In response to these deaths, victims’ families are filing lawsuits against the companies that market and sell these dangerous products. “The federal government tried to ban the substance in 2016 after an uptick in calls to poison control centers. But the American Kratom Association, consumers, scientists, and dozens of lawmakers objected to the restrictions, which would have curtailed kratom research and made possession a crime.” The debate between lawmakers and scientists highlights the tension between regulatory agencies, lawmakers, and medical experts who must balance medical research with protecting the public from harmful substances.
Like tianeptine, the FDA has not approved the sale of kratom in the United States. However, “the herb operates in a grey area of the law and is often sold online or at convenience stores and gas stations, usually in the form of capsules or loose powder.” Several states, including Alabama, Arkansas, and Wisconsin, have taken action and banned kratom. As a growing number of incidences related to tianeptine and kratom are reported, the FDA and lawmakers must grapple with how to protect communities from the emerging threat of unregulated substances.
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Sources
https://thehill.com/policy/healthcare/4427661-fda-warning-neptunes-fix-gas-station-heroin/
https://www.axios.com/2024/01/22/gas-station-heroin-tianeptine-drug
https://www.nytimes.com/2024/01/10/health/gas-station-heroin-tianeptine-addiction.html
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380661/
https://www.foodsafetynews.com/2023/12/industry-group-calls-for-fda-regulation-of-kratom/ https://www.vice.com/en/article/xgwpd7/gas-station-heroin-fda-congress