By Rose Hoban
State lawmakers are taking aim at a dietary supplement that’s become fashionable for its euphoric effects — similar to those of highly regulated narcotics.
Tianeptine, which is more commonly known as “gas station heroin,” “Zaza Red” and “Neptune’s Fix,” is sold at gas stations, convenience stores, bodegas and corner marts.
The supplement, marketed as a “cognitive function enhancer,” is available over the counter and has been widely featured across social media. It can produce a high from several pills and can be strongly addictive.
Given that, and a new national focus on the supplement that’s regulated in other countries, North Carolina lawmakers in a new House Select Committee on Substance Abuse at the General Assembly have begun to explore possible actions to protect people in this state from tianeptine’s detrimental side effects.
“When tianeptine is taken at high doses, it produces euphoria,” Penny Shelton, head of the N.C. Association of Pharmacists, told the new committee.
“Tianeptine in high doses is like any other substance with the potential for misuse and dependence, in that it does far more than create euphoria — or a high. It actually changes neuronal pathways in the brain,” she added. “This is particularly problematic for teens and young adults.”
In other countries, tianeptine is used as an antidepressant at a prescribed dose of 12.5 milligrams, three times a day. But tianeptine is not designated as a drug in the U.S.
In this country, it’s sold in doses as high as 150 milligrams per capsule in bottles of 20. That means someone can get as many as 3,000 milligrams of the supplement for less than $50.
Users in this country have described the supplement as extremely addictive and say stopping it can lead to intense withdrawal symptoms and cravings. Some have reported needing dozens of doses a day to avoid those effects.
The supplement is available at vape shops and other retail shops, and there are no age restrictions on who can purchase it.
Just last week, the U.S. Food and Drug Administration issued a warning, cautioning consumers to “avoid all products containing tianeptine, including those claiming to treat an ailment or disorder” and that the supplements have been linked to “serious harm, overdoses, death.”
That same day, the new commission began to discuss what lawmakers could do to curb its sale.
A constituent’s experience
Incidents involving tianeptine reported by poison control centers have surged in recent years, rising “from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone,” according to the FDA.
The North Carolina Office of the Chief Medical Examiner — which performs autopsies on all overdose deaths — has tracked tianeptine for five years, finding about one or two deaths from the substance annually.
That’s compared to the more than 4,000 deaths from opioids reported in 2022.
UNC Chapel Hill substance use researcher Nab Dasgupta wrote in an email to NC Health News that fentanyl continues to be the primary concern in street drugs, and tianeptine is likely not a significant overdose risk.
“What we have heard clinically is that taking large doses can lead to a nasty form of withdrawal and [of] people who have become dependent,” Dasgupta wrote. “This complicates addiction treatment [and] is likely to be the primary health concern to keep an eye on.”
That was the gist of a recorded audio message sent to committee chair Rep. Stephen Ross (R-Burlington) by a constituent who described his struggles getting off of tianeptine.
The man, who was unidentified, said he had started taking the substance to improve his energy. But his use quickly spiraled out of control, taking as many as 150 pills a day before he attempted to quit “cold turkey.”
“I didn’t sleep for I think seven days, after a couple of days of not having it I began to hallucinate,” the man said. “I didn’t hallucinate like someone would describe, you know, for euphoria. I hallucinated that I was gonna die and my family was gonna die.”
Eventually the man was able to detox over the course of several weeks in a hospital. But he relapsed.
“This drug just kept calling to me. I don’t know what better way to describe it, It was like an itch that you just couldn’t scratch and it just got harder and harder and harder,” he said.
Loophole allows for sale
Widespread sale of tianeptine is made possible by a large loophole in the law created by the federal Dietary Supplement Health and Education Act of 1994. The law ties the hands of the federal Food and Drug Administration from regulating substances marketed as “dietary supplements” before they enter the market.
Unlike pharmaceuticals, which are heavily regulated by the FDA, the agency is not empowered to preapprove substances labeled “supplements” before they’re sold to the public. The agency can penalize manufacturers and marketers making health claims about their products and issue health and safety warnings.
“Since these ‘gas station drugs’ are not regulated, consumers often don’t know what they’re getting when they purchase them,” said Stephanie Craycroft-Andrews, a pharmacologist from the mental health management organization, VAYA Health in western North Carolina. “[Consumers] can sometimes find higher amounts of drug than advertised or no drug at all.”
A 2014 report published by the Congressional Research Service noted that “more than half of vitamin and mineral supplement users reported thinking that the government pre-approves these products before they are marketed. While this is generally the case for drugs, it is not the case for dietary supplements.”
“This labeling can say pretty much whatever it wants,” said Sarah Howe, head of Addiction Professionals of North Carolina. “It looks organic, or it looks healthy, or whatever the case may be. People feel because it’s not bought on the street, it’s not from what they deemed maybe some clandestine source to get the substance, that it’s okay.”
“It’s a false sense of security,” Howe added.
Informal surveys have found that many supplement manufacturers do not guarantee that their products were made under the FDA’s “good manufacturing practice” standards and don’t provide Certificates of Analysis that guarantee that what’s on the label is in the supplements.
Recently, the FDA recalled one of the most popular brands of the tianeptine, Neptune’s Fix, because of “reasonable probability of life-threatening events including suicidal ideation or behavior” — especially for young people.
Shelton told lawmakers that it can be difficult for regulators to find and remove every box from store shelves.
On Jan. 11, the FDA sent a letter to retailers requesting they stop selling any remaining Neptune’s Fix and other product brands containing tianeptine.
Some distributing companies, such as Super Chill, have started to recall their products, according to the FDA.
Playing whack a mole
During the legislative hearing in North Carolina last week, members of the committee wondered aloud what the best course of action would be to halt tianeptine use in North Carolina.
A number of states, including Michigan, Alabama, Tennessee, Ohio, Kentucky and Florida, have banned the sale of tianeptine, but the substance remains available online.
One suggestion was to outlaw the drug by adding it to the list of drugs scheduled in North Carolina as controlled substances. Lawmakers have done that with several isomers of fentanyl as recently as 2021, but Howe said that continuing to schedule the newest popular street drug is akin to lawmakers playing whack-a-mole.
After the committee hearing, Shelton posited that perhaps lawmakers could write language restricting sale of substances that target brain chemistry in specified ways, so they don’t always end up chasing the latest fad.
Howe also encouraged the lawmakers to take a more sweeping approach.
“Why are we seeing this, why is this happening? I think that’s really the biggest question,” Howe said. “Why do we continue to see these different things that are popping up?”
“I think it’s a larger conversation about where we are societally,” she added. “We started talking about the increase in things like anxiety disorders, the increase in what the Surgeon General calls … the ‘illnesses of despair’ — loneliness, isolation — that started under the pandemic.”
Howe suggested that lawmakers pay more attention to prevention and treatment of the problems and unrealized societal expectations that lead many to chase the highs or euphoria that such supplements and other mind-altering substances offer.
“We do have to talk about labeling and marketing, and what are our kids seeing when they walk to school?” Howe said. “How many advertisements are they seeing along the way for alcohol?
“Every single thing we do and we teach from the youngest age is ‘to have a good time, I need a substance.’ ”
Teaching coping methods and resilience, particularly to children, also is important, Howe added.
“We can reschedule it, we can put more funding potentially, into informing consumers, we can maybe do some commercials or communications,” Howe said. “Ultimately, we still have to get at the heart of why we’re needing the substances, and how we reframe what we are teaching our children.”
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