Further, "The FDA doesn’t strictly regulate dietary supplements or approve them before they’re sold. But they have tracked down and sent warning letters to companies that sell tianeptine products. And some states have banned tianeptine, including: Alabama. Georgia. Indiana. Kentucky. Michigan. Mississippi. Ohio. Tennessee.
So the article discusses the impact on the supplement industry, which is far less regulated than the medical industry and even the food industry. I don't agree in that this does not further damage the supplement industry, but provides another indicator of how unregulated the industry is.
Natural Products Insider
https://www.naturalproductsinsider.com/supplement-regulations/tianeptine-sales-besmirch-supplement-industry-s-reputation-but-who-is-really-at-fault-?
Tianeptine sales besmirch supplement industry’s reputation, but who is really at fault?
A shadowy network supplies products featuring illegal drugs that are sold in convenience and liquor stores and smoke shops. Is that the fault of the dietary supplement industry?
Hank Schultz
January 12, 2024
Natural Products Insider
https://www.naturalproductsinsider.com/supplement-regulations/tianeptine-sales-besmirch-supplement-industry-s-reputation-but-who-is-really-at-fault-?
Tianeptine sales besmirch supplement industry’s reputation, but who is really at fault?
A shadowy network supplies products featuring illegal drugs that are sold in convenience and liquor stores and smoke shops. Is that the fault of the dietary supplement industry?
Hank Schultz
January 12, 2024
At a Glance
- Tianeptine sales have made a splash via a mainstream media news report.
- The 'loosely regulated' supplement industry is cast as a scapegoat for the actions of the purveyors of illegal drugs.
- A concerted industry effort is needed to counteract this false narrative.
Tianeptine, dubbed “gas station heroin,” is back in the news, giving the dietary supplement industry another black eye.
A recent front-page story in The New York Times sounded the alarm about tianeptine sales, under the following headline: ‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials.
The New York Times journalist, Jan Hoffman, provided the caveat that while some tianeptine brands label the products as supplements, the Food and Drug Administration “has explicitly said, for example, that tianeptine does not qualify as a dietary supplement.”
Nevertheless, the article expounded at length about how FDA only “loosely oversees” the dietary supplement industry.
It also made the case that the agency is hamstrung in its enforcement efforts, noting FDA “does not evaluate supplements for safety or effectiveness; it can only forbid manufacturers to market them as medical treatments.”
For good measure, the newspaper obtained a comment from Pieter Cohen, M.D., of Harvard Medical School. Despite several years of what appears to be respectful interaction between Cohen and industry leaders and trade organizations, he has remained steadfast in his view that the U.S. regulatory framework applicable to the industry is failing to adequately protect consumers.
Mainstream media often turns to him for a zinger about the regulation of dietary supplement products. The Times story was no exception.
“There are now at least a dozen different products that are foreign drugs being openly marketed as dietary supplements right under the FDA’s eyes, without them being able to stop the sales,” Cohen was quoted as saying in the article.
Tianeptine was first developed by French scientists as an antidepressant medication in the 1960s. It is prescribed in Europe and other jurisdictions around the world to treat depression and other medical conditions, such as anxiety disorders. It is not approved for any medical use in the United States, nor has it apparently ever been legally marketed as a dietary supplement here.
“FDA considers tianeptine to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive,” FDA concludes in a webpage.
A shadowy network of producers
A key element to the tianeptine affair is where these products are sold. Along with online avenues, many of these non-compliant products—whether they’re marketed for erectile dysfunction, focus enhancement or other indications—are sold via checkout stands at convenience stores, liquor stores and smoke shops.
The issue is not a new one. I spoke with Harvard-educated attorney Robert Tauler, of the law firm Tauler Smith LLP, who has spearheaded some lawsuits centered on these kinds of products and distribution channels.
Tauler said the attraction for store operators is these kinds of products tend to generate high margins and help the stores round the corner in a very competitive market.
“C-stores are a very difficult business and margins are very tight,” Tauler said.
Displays with wacky product names and outrageous claims are reliable profit centers that don’t require much work from the store owners themselves.
The displays are stocked by contractors who get the products from a shadowy network of producers who are often difficult to locate.
And that’s one of the big concerns from a safety standpoint. These products can vary widely in composition. Researchers associated with Boise State University, Montana Technological University and the University of Missouri Columbia recently conducted a chemical analysis of the three varieties of Tianaa (Red, Green and White SKUs), which is one of the branded products specifically cited in the Times article. The researchers found the tianeptine content varied by as much as 36% more and 33% less than what was stated on the label. In addition, they found other compounds not listed on the products.
“The pills themselves are either being made in China, or the raw ingredient is being shipped from China and are assembled here in ramshackle facilities that are certainly not inspected by FDA,” Tauler said.
‘Difficult,’ but not ‘impossible’
In a warning to consumers, FDA said the risks of using tianeptine can include “agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death.”
Tauler said the shadowy producers are difficult to find, and frequently will move their shop and change their names in response to being exposed.
However, “difficult” doesn’t mean “impossible.” After all, this is not like trying to detect industrial espionage rings operated by foreign governments. If Tauler and his associates have uncovered some of the secrets of this trade in illegal drugs via their own litigation fact finding, surely public prosecutors—with their vastly greater resources—could do more, he argued.
The fact that these producers are often small, however, means he doesn’t expect much will be done. And the customers who do a lot of their shopping in these kinds of stores tend to be from marginalized sectors of society, Tauler said, which further reduces the potential profile of the cases.
“Taking down a crypto king is a career-making move for a prosecutor,” Tauler said. “The people who are suffering in these cases are those who are overlooked by the establishment. No one is going out on a limb for those who can’t afford a Viagra prescription.”
Combatting a false narrative
So far, FDA has dealt with tianeptine primarily by issuing warning letters and consumer advisories. Is this because of a lack of resources, or competing priorities?
In the absence of vigorous enforcement, the present situation is likely to persist, with the implication in the mainstream media that the loose and casual regulation of the dietary supplement industry is somehow to blame for the actions of scofflaws who typically operate in the shadows and jeopardize public health.
What can be done to combat a false narrative? That’s by far the tougher question to answer. Despite an ostensible commitment to fair and balanced reporting, newspaper reporters and editors are as susceptible as the next professional to making snap judgements and harboring biases.
One approach could be to create a unified resource with buy-in from all the relevant industry stakeholders that would list all the ways in which supplements are regulated in the United States, including all the steps responsible manufacturers take to ensure their products are produced consistently according to quality standards, meet label claims and are free from undeclared contaminants.
This resource, along with FDA data and other evidence, could then be presented to editors and reporters to make the case that plenty of responsible players operate in the supplement industry.
Yes, there are many criminals operating on the fringes of the supplement industry, and the federal government should use its authorities to hold them accountable and swiftly remove dangerous products like tianeptine from store shelves.
But lest we forget, tianeptine doesn’t even qualify as a dietary supplement, and that’s according to FDA. When was the last time the American pharmaceutical industry was criticized for having a flawed regulatory framework due to the actions of Mexican cartels trafficking in fentanyl?
A recent front-page story in The New York Times sounded the alarm about tianeptine sales, under the following headline: ‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials.
The New York Times journalist, Jan Hoffman, provided the caveat that while some tianeptine brands label the products as supplements, the Food and Drug Administration “has explicitly said, for example, that tianeptine does not qualify as a dietary supplement.”
Nevertheless, the article expounded at length about how FDA only “loosely oversees” the dietary supplement industry.
It also made the case that the agency is hamstrung in its enforcement efforts, noting FDA “does not evaluate supplements for safety or effectiveness; it can only forbid manufacturers to market them as medical treatments.”
For good measure, the newspaper obtained a comment from Pieter Cohen, M.D., of Harvard Medical School. Despite several years of what appears to be respectful interaction between Cohen and industry leaders and trade organizations, he has remained steadfast in his view that the U.S. regulatory framework applicable to the industry is failing to adequately protect consumers.
Mainstream media often turns to him for a zinger about the regulation of dietary supplement products. The Times story was no exception.
“There are now at least a dozen different products that are foreign drugs being openly marketed as dietary supplements right under the FDA’s eyes, without them being able to stop the sales,” Cohen was quoted as saying in the article.
Tianeptine was first developed by French scientists as an antidepressant medication in the 1960s. It is prescribed in Europe and other jurisdictions around the world to treat depression and other medical conditions, such as anxiety disorders. It is not approved for any medical use in the United States, nor has it apparently ever been legally marketed as a dietary supplement here.
“FDA considers tianeptine to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive,” FDA concludes in a webpage.
A shadowy network of producers
A key element to the tianeptine affair is where these products are sold. Along with online avenues, many of these non-compliant products—whether they’re marketed for erectile dysfunction, focus enhancement or other indications—are sold via checkout stands at convenience stores, liquor stores and smoke shops.
The issue is not a new one. I spoke with Harvard-educated attorney Robert Tauler, of the law firm Tauler Smith LLP, who has spearheaded some lawsuits centered on these kinds of products and distribution channels.
Tauler said the attraction for store operators is these kinds of products tend to generate high margins and help the stores round the corner in a very competitive market.
“C-stores are a very difficult business and margins are very tight,” Tauler said.
Displays with wacky product names and outrageous claims are reliable profit centers that don’t require much work from the store owners themselves.
The displays are stocked by contractors who get the products from a shadowy network of producers who are often difficult to locate.
And that’s one of the big concerns from a safety standpoint. These products can vary widely in composition. Researchers associated with Boise State University, Montana Technological University and the University of Missouri Columbia recently conducted a chemical analysis of the three varieties of Tianaa (Red, Green and White SKUs), which is one of the branded products specifically cited in the Times article. The researchers found the tianeptine content varied by as much as 36% more and 33% less than what was stated on the label. In addition, they found other compounds not listed on the products.
“The pills themselves are either being made in China, or the raw ingredient is being shipped from China and are assembled here in ramshackle facilities that are certainly not inspected by FDA,” Tauler said.
‘Difficult,’ but not ‘impossible’
In a warning to consumers, FDA said the risks of using tianeptine can include “agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death.”
Tauler said the shadowy producers are difficult to find, and frequently will move their shop and change their names in response to being exposed.
However, “difficult” doesn’t mean “impossible.” After all, this is not like trying to detect industrial espionage rings operated by foreign governments. If Tauler and his associates have uncovered some of the secrets of this trade in illegal drugs via their own litigation fact finding, surely public prosecutors—with their vastly greater resources—could do more, he argued.
The fact that these producers are often small, however, means he doesn’t expect much will be done. And the customers who do a lot of their shopping in these kinds of stores tend to be from marginalized sectors of society, Tauler said, which further reduces the potential profile of the cases.
“Taking down a crypto king is a career-making move for a prosecutor,” Tauler said. “The people who are suffering in these cases are those who are overlooked by the establishment. No one is going out on a limb for those who can’t afford a Viagra prescription.”
Combatting a false narrative
So far, FDA has dealt with tianeptine primarily by issuing warning letters and consumer advisories. Is this because of a lack of resources, or competing priorities?
In the absence of vigorous enforcement, the present situation is likely to persist, with the implication in the mainstream media that the loose and casual regulation of the dietary supplement industry is somehow to blame for the actions of scofflaws who typically operate in the shadows and jeopardize public health.
What can be done to combat a false narrative? That’s by far the tougher question to answer. Despite an ostensible commitment to fair and balanced reporting, newspaper reporters and editors are as susceptible as the next professional to making snap judgements and harboring biases.
One approach could be to create a unified resource with buy-in from all the relevant industry stakeholders that would list all the ways in which supplements are regulated in the United States, including all the steps responsible manufacturers take to ensure their products are produced consistently according to quality standards, meet label claims and are free from undeclared contaminants.
This resource, along with FDA data and other evidence, could then be presented to editors and reporters to make the case that plenty of responsible players operate in the supplement industry.
Yes, there are many criminals operating on the fringes of the supplement industry, and the federal government should use its authorities to hold them accountable and swiftly remove dangerous products like tianeptine from store shelves.
But lest we forget, tianeptine doesn’t even qualify as a dietary supplement, and that’s according to FDA. When was the last time the American pharmaceutical industry was criticized for having a flawed regulatory framework due to the actions of Mexican cartels trafficking in fentanyl?
The New York Times story suggests that the supplement industry is flawed at its core. But every day American consumers vote with their dollars to say they want access to these products. It’s up to industry leaders to band together to consistently drive the narrative that this an industry full of responsible players who are stepping up to help Americans make their own choices to improve their health.
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