By Sean Moloughney, Editor03.20.24
Senator Dick Durbin (D-IL) told four trade groups he plans to reintroduce the Dietary Supplement Listing Act this year—legislation he previously tried to pass in 2022 that would require mandatory product listing with FDA before companies bring new products to market.
That bid ultimately failed after it was stripped from the FDA User Fee Reauthorization, but sparked disagreement and divisiveness among industry. Groups like the Natural Products Association (NPA) fervently opposed mandatory product listing (MPL) while the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) supported the idea.
FDA has continued to ask for MPL, most recently requesting additional authority in its 2025 budget, which totaled $7.2 billion.
In letters to CRN, CHPA, the American Herbal Products Association (AHPA), and the United Natural Products Alliance (UNPA), the Senate Majority Whip focused on tianeptine, an antidepressant drug that has been dubbed “gas station heroin.” Tianeptine has not been approved by FDA.
Durbin cited an investigation by ABC7 Chicago which found that Chris Haggarty, a 37-year-old man from Lorain County, OH, died in November 2023 after taking a product that was sold as a dietary supplement but actually contained tianeptine.
FDA has issued several warnings about tianeptine, as far back as 2018, noting it has continued to receive adverse event reports about products containing tianeptine, including reports of seizures, loss of consciousness, and death.
In his letters to the supplement associations, Durbin wrote: “Tianeptine can be found in retail outlets, and can create ‘opioid-like effects.’ It is not approved for use in the United States, but that has not deterred some unscrupulous companies from including it in their products and marketing them as dietary supplements that can treat substance use disorder. Such claims and marketing are illegal actions under the Federal Food, Drug, and Cosmetic Act. It also is cruel to those Americans who experience substance use disorder and need real support—not a cheap, unsubstantiated ‘fix.’ However, recent reporting indicates that tianeptine is reaching and harming consumers now more than ever before.”
Durbin urged the trade groups to support legislative efforts to empower FDA and requested they provide “a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market.”
“Priorities such as mandatory product listing, increasing inspection capacity, and clarifying FDA’s authority to better facilitate enforcement against unlawfully marketed products would enhance the agency's ability to identify and more quickly remove illegitimate products from the market,” he said.
This October will mark 30 years since the Dietary Supplement Health and Education Act of 1994 (DSHEA) opened up opportunities for a thriving marketplace.
“... when this law was originally enacted, industry has grown from $4 billion to more than $50 billion today,” Melville noted. “Without modernization, bad actors will continue to prey on the fact that regulations have not kept pace with growth. DSHEA should protect the 21st century consumer who has access to an ever-expanding dietary supplement marketplace, and CHPA looks forward to continuing to work with FDA and Congress on the shared goal of regulatory modernization.”
CRN also said it shares Durbin’s concerns that tianeptine is being fraudulently marketed as a dietary supplement when it is an unsafe and illegal substance.
“CRN’s members, and all responsible supplement marketers, do not sell this ingredient and condemn the sale of it. CRN has not only been vocal about the risks associated with products containing tianeptine misrepresented as dietary supplements, but has also shown steadfast support for enhancing FDA’s regulatory oversight through initiatives like a product listing registry for supplements. We offered our strong support for Senator Durbin’s previous bill seeking to make product listing a reality, and we look forward to working with him again if new legislation is introduced.”
CRN also urged FDA to take enforcement action against products containing tianeptine, encouraged consumers to purchase supplements from reputable sources, and to report any adverse events to the FDA's MedWatch program.
“Our support for legislative and regulatory efforts that enhance consumer protection, such as product listing bills, aligns closely with the concerns expressed in Senator Durbin's letter, emphasizing a shared commitment to preventing the distribution of dangerous or illegal ingredients posing as dietary supplements,” CRN said in its statement.
He also noted that in 2022, Congress expressed significant concerns with MPL.
“Congress has spoken on this issue,” he said, “and giving FDA an administrative excuse to reject ingredients from being marketed as dietary supplements, regardless of the science or history, is a non-starter.”
Responding to Durbin’s statement, Fabricant said that “As the oldest and largest trade association in the space our letter must have been lost in the mail.”
He challenged the idea that MPL would solve the issue of tianeptine and called the proposal “an attack on DSHEA to ultimately saddle the industry with pre-market approval.”
“If the problem is tianeptine and illegal products masquerading as supplements, products that have never been supplements, then why do these proposals only burden the rule followers and those who are involved in the legitimate business of supplements? It defies logic. We might as well go after the Treasury Department for bank robbers.”
Fabricant also said FDA has a “willpower issue” and should pursue illegal products “with the same fervor they pursue new and unnecessary authorities.”
He also urged the agency “to promptly use its authority to remove such unlawful products from the market. AHPA looks forward to continuing our discussions with Senator Durbin and other lawmakers to address the agency’s lack of enforcement on this matter.”
“These are not sales venues that responsible dietary supplement companies use,” he noted. “We hope your office will be in contact with the relevant trade associations that represent or own gas stations, smoke shops, truck stops, etc. We believe they are the principal parties that could quickly stop the sale of tianeptine from outlets they own or control.”
Israelsen also expressed the need for FDA to “demonstrate its commitment to remove this product from the market as part of its public health mission.”
Regarding Durbin’s reintroduction of the Dietary Supplement Listing Act, Israelsen said UNPA would read the language of the bill closely and offer views on the new version.
“As you know, we have been generally supportive of your most recent introduced version, but did have concerns about language proposed to be added in the HELP Committee version.”
That bid ultimately failed after it was stripped from the FDA User Fee Reauthorization, but sparked disagreement and divisiveness among industry. Groups like the Natural Products Association (NPA) fervently opposed mandatory product listing (MPL) while the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) supported the idea.
FDA has continued to ask for MPL, most recently requesting additional authority in its 2025 budget, which totaled $7.2 billion.
In letters to CRN, CHPA, the American Herbal Products Association (AHPA), and the United Natural Products Alliance (UNPA), the Senate Majority Whip focused on tianeptine, an antidepressant drug that has been dubbed “gas station heroin.” Tianeptine has not been approved by FDA.
Adverse Events Related to Tianeptine
In a press release, Durbin cited data from U.S. poison control centers indicating there were 1,100 calls related to tianeptine across the U.S. between 2019 and 2023, with 400 such calls in 2023 alone, compared to just 11 tianeptine-related calls between 2000 and 2013.Durbin cited an investigation by ABC7 Chicago which found that Chris Haggarty, a 37-year-old man from Lorain County, OH, died in November 2023 after taking a product that was sold as a dietary supplement but actually contained tianeptine.
FDA has issued several warnings about tianeptine, as far back as 2018, noting it has continued to receive adverse event reports about products containing tianeptine, including reports of seizures, loss of consciousness, and death.
In his letters to the supplement associations, Durbin wrote: “Tianeptine can be found in retail outlets, and can create ‘opioid-like effects.’ It is not approved for use in the United States, but that has not deterred some unscrupulous companies from including it in their products and marketing them as dietary supplements that can treat substance use disorder. Such claims and marketing are illegal actions under the Federal Food, Drug, and Cosmetic Act. It also is cruel to those Americans who experience substance use disorder and need real support—not a cheap, unsubstantiated ‘fix.’ However, recent reporting indicates that tianeptine is reaching and harming consumers now more than ever before.”
Durbin urged the trade groups to support legislative efforts to empower FDA and requested they provide “a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market.”
Show of Support from CHPA and CRN
CHPA President and CEO Scott Melville commended Durbin for “recognizing the need for a modernized regulatory structure for dietary supplements that will further protect public health.”“Priorities such as mandatory product listing, increasing inspection capacity, and clarifying FDA’s authority to better facilitate enforcement against unlawfully marketed products would enhance the agency's ability to identify and more quickly remove illegitimate products from the market,” he said.
This October will mark 30 years since the Dietary Supplement Health and Education Act of 1994 (DSHEA) opened up opportunities for a thriving marketplace.
“... when this law was originally enacted, industry has grown from $4 billion to more than $50 billion today,” Melville noted. “Without modernization, bad actors will continue to prey on the fact that regulations have not kept pace with growth. DSHEA should protect the 21st century consumer who has access to an ever-expanding dietary supplement marketplace, and CHPA looks forward to continuing to work with FDA and Congress on the shared goal of regulatory modernization.”
CRN also said it shares Durbin’s concerns that tianeptine is being fraudulently marketed as a dietary supplement when it is an unsafe and illegal substance.
“CRN’s members, and all responsible supplement marketers, do not sell this ingredient and condemn the sale of it. CRN has not only been vocal about the risks associated with products containing tianeptine misrepresented as dietary supplements, but has also shown steadfast support for enhancing FDA’s regulatory oversight through initiatives like a product listing registry for supplements. We offered our strong support for Senator Durbin’s previous bill seeking to make product listing a reality, and we look forward to working with him again if new legislation is introduced.”
CRN also urged FDA to take enforcement action against products containing tianeptine, encouraged consumers to purchase supplements from reputable sources, and to report any adverse events to the FDA's MedWatch program.
“Our support for legislative and regulatory efforts that enhance consumer protection, such as product listing bills, aligns closely with the concerns expressed in Senator Durbin's letter, emphasizing a shared commitment to preventing the distribution of dangerous or illegal ingredients posing as dietary supplements,” CRN said in its statement.
NPA Checking the Mail, Continues Opposition
After FDA issued its budget request, NPA President and CEO Daniel Fabricant, PhD, said: “Year after year, the FDA’s budget proposal includes mandatory product listing. Congress has routinely shut down this proposal, another example of the FDA being distracted from doing the basics. While the FDA continues to receive more funding, the previous price tag for mandatory product listing was $34 million and does not include the millions spent for the NIH Dietary Supplement Label Database.”He also noted that in 2022, Congress expressed significant concerns with MPL.
“Congress has spoken on this issue,” he said, “and giving FDA an administrative excuse to reject ingredients from being marketed as dietary supplements, regardless of the science or history, is a non-starter.”
Responding to Durbin’s statement, Fabricant said that “As the oldest and largest trade association in the space our letter must have been lost in the mail.”
He challenged the idea that MPL would solve the issue of tianeptine and called the proposal “an attack on DSHEA to ultimately saddle the industry with pre-market approval.”
“If the problem is tianeptine and illegal products masquerading as supplements, products that have never been supplements, then why do these proposals only burden the rule followers and those who are involved in the legitimate business of supplements? It defies logic. We might as well go after the Treasury Department for bank robbers.”
Fabricant also said FDA has a “willpower issue” and should pursue illegal products “with the same fervor they pursue new and unnecessary authorities.”
AHPA: FDA Should Use its Authority to Enforce the Law
Michael McGuffin, president of AHPA, said the trade group and the rest of responsible industry “opposes the marketing and distribution of products containing tianeptine that unlawfully masquerade as dietary supplements.”He also urged the agency “to promptly use its authority to remove such unlawful products from the market. AHPA looks forward to continuing our discussions with Senator Durbin and other lawmakers to address the agency’s lack of enforcement on this matter.”
UNPA: Point of Sale for Tianeptine (Gas Stations and Smoke Shops)
In a response letter to Durbin, UNPA President and Founder Loren Israelsen noted that tianeptine is largely sold at “gas stations, smoke shops, truck stops, and the darker corners of the Internet.”“These are not sales venues that responsible dietary supplement companies use,” he noted. “We hope your office will be in contact with the relevant trade associations that represent or own gas stations, smoke shops, truck stops, etc. We believe they are the principal parties that could quickly stop the sale of tianeptine from outlets they own or control.”
Israelsen also expressed the need for FDA to “demonstrate its commitment to remove this product from the market as part of its public health mission.”
Regarding Durbin’s reintroduction of the Dietary Supplement Listing Act, Israelsen said UNPA would read the language of the bill closely and offer views on the new version.
“As you know, we have been generally supportive of your most recent introduced version, but did have concerns about language proposed to be added in the HELP Committee version.”
