VRM Media
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale?
If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and Drug Administration (FDA) expanded authority to regulate dietary supplements?
“Gas station heroin” is a slang term for tianeptine, an unsafe, unapproved drug that’s use reportedly has led to an increase in calls to poison control centers and severe adverse effects. FDA has said that products labeled as dietary supplements that contain tianeptine are unsafe—“dietary supplements containing tianeptine are adulterated under the Act.” (www.fda.gov/food/cfsan-constituent-updates/fda-takes-action-products-marketed-dietary-supplements-containing-tianeptine-and-warns-consumers).
There do not appear to be any reputable members of the dietary supplement industry advocating for the continued sale of tianeptine and it does not appear to be found for sale by any reputable dietary supplement retailers. According to a press release issued by Representative Frank Pallone on April 23, “Tianeptine mimics the sedative effects of opioids and is sold in smoke shops, convenience stores and gas stations, which has led to its ‘gas station heroin’ nickname.” (https://democrats-energycommerce.house.gov/media/press-releases/pallone-introduces-bill-prohibit-sale-gas-station-heroin).
The FDA currently has considerable authority to regulate the dietary supplement industry. Under the Federal Food, Drug and Cosmetic Act (FD&C Act), it is a prohibited act to introduce into interstate commerce any food, drug, device, tobacco product or cosmetic that is adulterated or misbranded. 21 USC 331(a). Under this provision, dietary supplements are food.
Six years ago, in 2018, FDA issued two warning letters concerning tianeptine: one to MA Labs LLC and one to Jack B Goods Outlet Store. In both letters, FDA’s primarily contention was that the products in question were “adulterated” because:
Tianeptine is not a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of the preceding substances. Accordingly, tianeptine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)].
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)]. Adulterated foods cannot be legally imported or marketed in the United States.
MA Labs LLC—(www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ma-labs-llc-566831-11072018); see also Jack B Goods Outlet Store—(www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jack-b-goods-outlet-store-566674-11072018).
Both warning letters were signed by the Director Office of Compliance, Center for Food Safety and Applied Nutrition.
About three years later, on May 18, 2021, the FDA Division of Pharmaceutical Quality Operations, Center for Drug Evaluation and Research (CDER), issued a warning letter to Umbrella (www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/umbrella-612037-05182021) primarily alleging that “Tianeptine Sodium Solution,” among other products was not generally recognized as safe and effective for claimed uses and was, therefore a “new drug” under 21 U.S.C. § 321(p) of the FD&C Act. “New drugs” may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
CDER issued a similar warning letter to Crystal Clear Supplements on Feb. 4, 2022 (www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/crystal-clear-supplements-620285-02042022) also stating, among other things. that based on product claims, “Tianeptine Sodium Powder” and “Tianeptine Sulfate Powder” were not generally recognized as safe and effective for the claimed uses and were “new drugs” that could not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
These are not the only enforcement actions that FDA has engaged in concerning tianeptine. Import Alert 54-16—“Detention without physical examination of product that are marketed as foods, including products marketed as dietary supplements that contain an active pharmaceutical ingredient” (www.accessdata.fda.gov/cms_ia/importalert_1141.html) includes one company added to the list in 2015 for trying to import a propolis extract, in which tianeptine was detected.
If tianeptine is an unsafe active pharmaceutical ingredient in products marketed as foods, why has this import alert not been expanded to include all dietary supplements that contain tianeptine for automatic import detention?
Finally, FDA has been instrumental in bringing at least two criminal actions against marketers of tianeptine.
On Sept. 7, 2023, the United States Attorney’s Office for the District of Massachusetts in conjunction with the FDA’s Office of Criminal Investigation announced that a California man had pled guilty to smuggling an “alleged cognitive enhancement drug.” According to the press release, the defendant had “smuggled tianeptine, a misbranded drug, from China into the United States and then resold the tianeptine to American consumers on the internet through his company, Supplements for Work. [The defendant] falsely represented that he was selling tianeptine for research purposes only, even though he sold tianeptine to individuals for personal use. [The Defendant], through his company, marketed tianeptine as a mood enhancer and claimed that it improved cognitive functioning. The defendant pleaded guilty to one count of conspiracy and two counts of introduction of misbranded drugs with intent to defraud and mislead. (www.justice.gov/usao-ma/pr/california-man-pleads-guilty-smuggling-alleged-cognitive-enhancement-drug-united-states). The defendant was ultimately sentenced to two years in prison, to be followed by three years of supervised release and ordered to pay a forfeiture of $1,833,922.
In a second criminal enforcement action, the FDA Office of Criminal Investigations and U.S. Postal Inspection Service, working with the U.S. Attorney’s Office District of New Hampshire announced on Feb. 5, 2024, that Centera Bioscience, d/b/a Nootropics Depot and the company’s CEO had pleaded guilty to the introduction of misbranded drugs into interstate commerce.
The company was sentenced to three years of probation, while the company’s CEO was sentenced to one year of probation, and both were ordered to pay a $2.4 million forfeiture and surrender all drugs seized by the FDA and Customs and Border Protection. (www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/arizona-company-and-ceo-sentenced-illegal-distribution-tianeptine-and-other-drugs-and-ordered).
These enforcement actions unequivocally demonstrate that FDA and when necessary, working with other parts of the government, has adequate authority to bring effective enforcement action targeted at marketers of products containing a dangerous ingredient like tianeptine.
Considering the FDA actions described above, why is it necessary for Congress to amend the FD&C Act to give the FDA new enforcement authority for the specific purpose of dealing with tianeptine? And, more to the point, why is the legitimate dietary supplement industry being blamed and held to responsibility for the marketing of tianeptine containing products?
On April 23, 2024 Representative Frank Pallone announced that he was introducing a bill in the House of Representatives “to Prohibit Sale of “Gas Station Heroin” [H.R. 8183] (https://pallone.house.gov/media/press-releases/pallone-introduces-bill-prohibit-sale-gas-station-heroin). This was followed a week later by a similar announcement from Senators Durbin and Blumenthal introducing a bill in the Senate also with the specific purpose “to Prohibit Sale Of Tianeptine” [S.4125] (www.durbin.senate.gov/newsroom/press-releases/durbin-blumenthal-introduce-bill-to-prohibit-sale-of-tianeptine#:~:text=The%20Prohibiting%20Tianeptine%20and%20Other%20Dangerous%20Products%20Act%20will%20protect,the%20country%2C%E2%80%9D%20said%20Blumenthal).
The proposed bills Text – H.R.8123 – 118th Congress (2023-2024): To amend the Federal Food, Drug and Cosmetic Act to establish new prohibited acts relating to dietary supplements. | Congress.gov | Library of Congress would add two new prohibited acts to the FD&C Act.
Specifically, if enacted “the introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff)” would be a prohibited act. It would also be a prohibited act for a “debarred” person or entity to prepare, pack or hold any dietary supplements.
The FDA would also have expanded authority to seize products and exclude imports of products that violated these new provisions.
Senator Durbin has long been a critic of the dietary supplement industry. On March 19, the Senator issued a press release citing a letter he had written to a number of dietary supplement trade associations on his plan to introduce the “Dietary Supplement Listing Act,” better known as “Mandatory Product Listing” calling on the dietary supplement industry to take action against tianeptine:
The letter concluded, “I will reintroduce the Dietary Supplement Listing Act this year. In the face of mounting public health threats, I urge the [Dietary Supplement Trade Association] to help support legislative efforts such as this that would ensure the FDA can protect consumers effectively. I also request that the [Dietary Supplement Trade Association] provide my office with a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market. Let me be clear: we must take substantive action to ensure that other mothers, fathers, siblings and friends do not experience the same pain and suffering that Karen [the mother of a person who died from consuming tianeptine] faces now.” (www.durbin.senate.gov/newsroom/press-releases/durbin-urges-trade-groups-to-take-action-against-tianeptine-an-opioid-like-ingredient-found-in-some-products-marketed-as-dietary-supplements).
What is the issue with all of this? These members of Congress are focusing on the wrong problem and blaming the wrong people. Why is Durbin asking “responsible supplement manufacturers” to come up with a written plan to remove tianeptine and similar dangerous or illegal ingredients from the market? Is there anything to suggest that such products are being produced by responsible supplement manufacturers? Further, is there anything to suggest that these products are being sold by responsible dietary supplement retailers? According to Pallone’s press release, this is a problem with products being “sold in smoke shops, convenience stores and gas stations, which has led to its ‘gas station heroin’ nickname.”
So why is the legitimate dietary supplement industry being held responsible and why are members of Congress looking to amend the FD&C Act when such an amendment is not necessary to address the specific problem of tianeptine?
Other than general statements, there do not seem to be any real reasons provided by these members of Congress explaining why the FD&C Act must be amended to include new prohibited acts specifically to address tianeptine. It seems that the purpose of the new provisions is to remove the current requirement that FDA must establish that a product is adulterated (unsafe) or misbranded (labeling false or misleading) to bring an enforcement action. Why are these members of Congress looking to remove these prerequisites for FDA enforcement?
We already know that FDA has taken enforcement action against tianeptine because products containing it are adulterated. We already know that FDA has taken enforcement action against tianeptine products because they were misbranded. We even know that the government currently has the authority to charge tianeptine marketers with criminal violations of the FD&C Act.
This movement in Congress does not seem to have anything to do with tianeptine and the entities illegally marketing such products as dietary supplements. The concern is that these amendments will provide FDA with the new authority to bring actions against dietary supplements that are manufactured by responsible manufacturers and are sold by responsible dietary supplement retailers when there is no safety issue and there is nothing false or misleading on labels and labeling.
The response to the new proposed legislation and Durbin’s request that the dietary supplement industry develop a plan to remove these products from the market is quite simple: Tell FDA to effectively enforce the law as it is already written and to bring serious enforcement actions against dangerous products it has already stated are illegal.
For Congress to consider allocating additional funds to support a “Dietary Supplement Listing Act,” when FDA is not currently effectively enforcing against illegal products easily located is a total waste. If sparse enforcement against tianeptine and similar dangerous ingredients is due to a lack of resources, then perhaps direct funding for additional enforcement may be warranted.
The supplement industry should not be blamed for outside actors selling dangerous and illegal products. Nor should new burdens be placed on the legitimate supplement industry that scofflaws, and criminals will ignore just as readily as they ignore the current law.
Reprinted with permission from VRM Media.
