Industry wary of wider consequences of anti-tianeptine bills

Rep. Frank Pallone, D-NJ, and Sen. Dick Durbin, D-IL, have introduced companion bills in both chambers of Congress meant to give FDA more authority to stop the sale of tianeptine products. Industry sources say the new authority is not needed and in fact could be counterproductive. 

The new bills seek to amend the federal Food Drug & Cosmetic Act to introduce a new prohibited act. That would make it illegal to introduce into interstate commerce any product marketed as a supplement that does not fit the federal definition of what a dietary supplement should be. 

Tianeptine, also known in the mainstream press as “gas station heroin,” is a prescription antidepressant drug that is distributed under several brand names in a number of countries. It is not approved in the U.S. for any medical use. It has also been mentioned in off label uses such as pain, asthma and anxiety. 

Tianeptine effects 

In higher doses, tianeptine can have opioid-like effects, which explains its popularity in demimonde distribution channels. High doses can potentially bring on drowsiness, confusion, difficulty breathing, coma and even death. 

According to the Mayo Clinic, some consumers have used tianeptine to self-treat symptoms of withdrawal from alcohol or other drugs. People with a history of substance misuses may be at more risk of misusing tianeptine, the clinic said. 

Related:Tianeptine sales spur another FDA warning, action by state lawmakers

Tianeptine exposure reports started ramping up at poison control centers starting around 2015. The phenomenon is gaining momentum.  

According to a press release issued by Pallone’s office yesterday, 391 cases were reported nationwide last year, including 27 in New Jersey alone. 

Congressional concern 

Earlier this month, Pallone wrote to Health Resources and Services Administration Carole Johnson about the FDA warning letter sent to the manufacturer of Neptune’s Fix, a product that contained tianeptine, and the voluntary recall that resulted. 

“Despite the voluntary recall, I remain concerned that these products and other similar ones may still be on stores shelves, jeopardizing the health of our communities, and particularly our kids,” Pallone wrote. “As the Administrator who oversees our Poison Control Centers, I urge you to take action to support our Poison Control Centers more widely in responding to the increase of calls.” 

“Americans put their trust and faith in a dietary supplement to improve their health and well-being,” Durbin said. “But some unscrupulous companies have abused that trust and marketed illegal — and dangerous — ingredients in some of these products, such as tianeptine. 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 Congressman Pallone for working with me on this important legislation.” 

Related:FDA still receiving reports related to ‘gas station heroin’

Attorney: New authority not needed 

While no one within the industry is advocating for tianeptine to be available in convenience stores the way it is now, they caution that the new prohibited act that Durbin and Pallone are proposing could be used to squelch other products on the market such as CBD, NMN and NAC. 

“They don’t need to amend the law to go after tianeptine,” said attorney Robert Durkin, who a partner and co-chair of the food and drug law practice at the firm Arnall Golden Gregory LLP. Durbin has done a stint at FDA. 

“FDA already has all the authority it needs to go after tianeptine,” he stressed. 

Durkin said any food — and that includes supplements — that contains tianeptine would already be deemed adulterated under existing federal statutes. And to introduce such a product into interstate commerce is already a violation of the law. 

“What this bill tries to do is to add another prohibited act, a prohibited act that is not needed,” he said. 

It’s not a lack of authority that is the issue, in Durkin’s view. It’s that FDA has often been reluctant to use the authorities it already has. 

NPA urges members to oppose bills 

The Natural Products Association issued a call to its members yesterday to oppose the bills via grassroots action. 

NPA said the bills would allow “FDA to prohibit the marketing of certain ingredients in dietary supplements without rendering a safety opinion.” 

That means ingredients that might have lingering regulatory questions but about which there are no safety concerns could be excluded from the market without any scientific corroboration. 

The members note went on to corroborate Durkin’s view on the lack of vigorous use of existing authorities on the part of FDA. 

“The FDA has the tools necessary to go after illegal products like tianeptine. Proposals like this make one think that the agency is genetically predisposed against basic law enforcement and would much rather spend taxpayer-funded time and resources pursuing overreaching authorities that muddy the waters for legitimate dietary ingredients,” it said.  

CRN in consultation mode 

Craig Muckle, senior director of communications for the Council of Responsible Nutrition, had this to say about the bills: “We are reviewing the legislation, and we will be discussing it with our members.”