FDA still receiving reports related to ‘gas station heroin’

The U.S. Food and Drug Administration continues to receive adverse event reports following consumers’ exposure to products containing tianeptine, according to an FDA spokesperson.

Also known as gas station heroin, tianeptine has captured the attention of the national media, regulators, poison control centers and lawmakers.

FDA has identified cases in which people have suffered serious harmful effects — including confusion, coma and death — from abusing or misusing tianeptine by itself or with other drugs. Additional adverse effects have included agitation, drowsiness, high blood pressure, nausea, rapid heartbeat, slowed or stopped breathing, sweating and vomiting.

But FDA may not be aware of all adverse events involving tianeptine, as not all of them are reported to the agency, according to the FDA spokesperson.

“The FDA’s evaluation of adverse events related to tianeptine is ongoing and the agency will provide additional safety information, as warranted,” she said.

Meanwhile, FDA continues to urge people not to use any tianeptine product.

“The FDA will continue to take regulatory actions and alert consumers of safety issues related to tianeptine products,” the FDA spokesperson said, adding that her “agency is working with U.S. Customs and Border Protection to help stop imports of tianeptine.”

Related:Industry wary of wider consequences of anti-tianeptine bills

On Jan. 31, CBP announced that its officers at the port of Cincinnati seized 12 pounds of tianeptine that had originated in Hong Kong and were destined for Houston, with a domestic value of over $246,000.

Shannon Aldrich, a health fraud investigator in FDA’s Office of Regulatory Affairs (ORA), said tianeptine is an antidepressant not approved for any medical use in the U.S., yet it has been sold at gas stations and is “often next to all the ‘5-hour Energy’ sold at the counter.”

The substance has a “very high potential for addiction,” she noted at recent scientific conference in Oxford, Mississippi.

According to FDA, tianeptine:

• Has been labeled as a dietary supplement but does not qualify as a dietary ingredient.

• Is an unsafe food additive.

• Supplements containing it are considered adulterated under the Federal Food, Drug and Cosmetic Act (FDCA).

FDA said tianeptine also is known as tianeptine sulfate, tianeptine sodium powder, tianaa, tianna green, tianna red and tianna white.

Copycat tianeptine product

Speaking at the aforementioned 22^nd annual International Conference on the Science of Botanicals, Aldrich mentioned a tianeptine product known as Neptune Fix and noted FDA started receiving reports that she described as “incredibly unusual.”

“It was, ‘I drank this elixir. I crashed my car. I blacked out and I ended up in the ER.’ And we kept getting variations of this,” the FDA health fraud investigator shared. “This is not normal for tianeptine. What else is going on? Finally, we drilled down on this company, Neptune Resources, the responsible party for this product. And they tell us actually there is this other entity … copycatting their product, and that company’s name is Super Chill.”

On Jan. 28, FDA linked to a press release that Neptune Resources was voluntarily recalling all lots of its Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir and Neptune's Fix Tablets. According to the company, its “distribution channels have not reported any adverse events from the use of its products.”

“The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use,” the press release said. “The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.”

FDA announced in February that Super Chill Products — “another distributor of Neptune’s Fix” — was recalling its products, although the company hadn’t issued a public notice to alert consumers of the recall.

Withheld case file on Neptune Resources

Natural Products Insider has been unable to find contact information for Neptune Resources or the distributor of Super Chill Products. FDA in February withheld an investigative case file in response to a Freedom of Information Act (FOIA) request, which sought all copies of written correspondence between FDA and Neptune Resources.

In response to the FOIA request filed by Natural Products Insider, FDA maintained the case file was exempt from disclosure because the “disclosure could reasonably be expected to interfere with enforcement proceedings.” The agency also cited other federal regulations for withholding the file, including a regulation (45 C.F.R. § 5.31(g)(1)) that “protects records or information compiled for law enforcement purposes, to the extent that the production of such records could reasonably be expected to interfere with enforcement proceedings.”

Tianeptine legislation

Amid concerns over tianeptine, Sen. Dick Durbin (D-Ill.) revealed in March that he intended to reintroduce a bill this year that would require a listing of dietary supplement products with FDA. Mandatory product listing would have helped in the case of tianeptine, according to Aldrich.

“It can be very difficult to locate responsible parties to this product,” she said.

Recently, Durbin, Sen. Richard Blumenthal (D-Conn.) and Rep. Frank Pallone (D-N.J.) introduced companion bills to stop the sale of tianeptine products, though some industry sources argued the authority was unnecessary and could be counterproductive. The new legislation seeks to amend the FDCA to introduce a new prohibited act, making it illegal to introduce into interstate commerce any product marketed as a dietary supplement that does not fit the federal definition of a dietary supplement.

Citing America’s Poison Control Centers based on an article in The New York Times, Durbin noted 391 tianeptine cases were reported nationwide in 2023.

“Americans put their trust and faith in a dietary supplement to improve their health and well-being. But some unscrupulous companies have abused that trust and marketed illegal — and dangerous — ingredients in some of these products, such as tianeptine,” Durbin said in an April 30 press release announcing introduction of the legislation. “As a result, some consumers have been sickened, and even died. Consumers deserve to know that these products are safe. In the face of this mounting public health threat, we must pass legislation to provide FDA with the authorities it needs to rid the market of tianeptine and other dangerous ingredients. I’m grateful to Senator Blumenthal and Congressman Pallone for working with me on this important legislation.”