FDA Urges Retailers to Stop Selling Tianeptine, “Gas Station Heroin” (2024)

Table of Contents

1. What the FDA Did in January 2024
2. The November 2023 Safety Alert That Came First
3. What Tianeptine Is, in the FDA’s Words
4. The Harms the FDA Reported
5. Where the Products Were Sold
6. The January and February 2024 Recalls
7. What the Action Does Not Do
8. Dates and Status as of 11 October 2026
9. The 2026 DEA Proposal to Place Tianeptine in Schedule I
10. How the 2024 Action Fits Earlier and Later Steps
11. Reporting Problems: What the FDA Documents List
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did in January 2024

Document type: a letter, addressed “To Whom it May Concern,” dated 11 January 2024 and signed by the Health Fraud Branch of the FDA’s Office of Regulatory Affairs in Rockville, Maryland. It is not a Federal Register rule or order and has no public comment docket. The FDA’s tianeptine safety page describes it as a letter sent “to convenience store, gas station and other organizations urging retailers to stop selling” the product and any other tianeptine-containing products.

What it asked. The letter states: “FDA is urging all retailers to STOP selling” the named product “and any tianeptine-containing products.” It asks trade associations to “please share the message above and information below to keep consumers safe,” and gives links to two FDA pages: the consumer warning about the product and tianeptine in general, and an FDA consumer update on tianeptine products linked to serious harm, overdoses and death.

Why retailers. The letter explains why the FDA wrote to the retail trade rather than only to the public: “We are reaching out because most consumers report purchasing this product at local gas stations or convenience stores across the country.”

What the FDA said it was doing. The letter states that the FDA “is actively investigating new reports in conjunction with local and state health departments,” and that it is “aware that” the product “and other tianeptine-containing products are sold illegally online and in other retail locations.”

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2. The November 2023 Safety Alert That Came First

The letter opens by recalling that the FDA “issued a public safety alert on November 21, 2023, after receiving multiple reports of serious medical injuries” related to the product, which “is labeled to contain the dangerous and addictive ingredient tianeptine.”

The FDA’s safety page keeps that 21 November 2023 entry. In it the agency warns consumers not to purchase or use the product “or any other product with tianeptine,” which it calls “a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.” The entry reports severe adverse event reports “including seizures and loss of consciousness leading to hospitalization,” and states that the product’s labels say it contains tianeptine, “but the product may contain other harmful ingredients not listed on the label.” The FDA said it was testing the products and would “provide more information as it becomes available.”

The 2024 steps — the retailer letter and the recalls — built on that alert. The November 2023 alert itself falls outside this page’s year and is reported here as background.

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3. What Tianeptine Is, in the FDA’s Words

The FDA’s most recent update to its tianeptine safety page, dated 8 May 2025, gives the agency’s summary of the substance’s legal position in the United States. Tianeptine:

• “is not approved by the FDA for any medical use” — no tianeptine medicine has gone through FDA review for safety and effectiveness;
• “is not generally recognized as safe for use in food” — “generally recognized as safe,” or GRAS, is the status that lets a substance be added to food without a separate FDA approval;
• “does not meet the statutory definition of a dietary ingredient” — the federal food and drug law lists the kinds of ingredients (such as vitamins, minerals and herbs) that a dietary supplement may contain, and the FDA states that tianeptine is not one of them.

“Nevertheless,” the page continues, tianeptine “is being marketed as a ‘research chemical,’ a ‘nootropic’ cognitive enhancer, or a dietary supplement.” A nootropic is a product sold with claims to improve memory, focus or other mental functions. The same page notes that “Tianeptine has also been referred to as ‘gas station heroin.’”

The DEA’s 2026 proposed rule (section 9) adds background from the federal scheduling review: it describes tianeptine as structurally and pharmacologically a tricyclic antidepressant that is approved as a prescription medicine in European, Asian and Latin American countries, typically for depression, and states that “there are no tianeptine products approved for medical use in the United States.” Background on the condition it is prescribed for abroad is on the site’s Depression page.

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4. The Harms the FDA Reported

The FDA documents describe the following, each in the agency’s own framing:

• Seizures, loss of consciousness and death. The January 2024 letter says the FDA “continues to receive reports of consumers who have suffered seizures, loss of consciousness or other adverse health events after ingesting this product.” The safety page’s 23 January 2024 entry states that the FDA “continues to receive severe adverse event reports” after use of the product, “including seizures, loss of consciousness and death.”
• Drug interactions. The same entry states that the products “may also interact, in life-threatening ways, with other medications a consumer may be taking.”
• Unlisted ingredients. The November 2023 entry states that the product “may contain other harmful ingredients not listed on the label.”
• Opioid-like effects. The letter cites the Centers for Disease Control and Prevention (CDC): “the clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity/withdrawal.” Background on opioid poisoning is on the site’s Opioid Overdose page.
• Very large doses. The May 2025 update states that “case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products.”

The DEA’s 2026 proposal, drawing on the Department of Health and Human Services (HHS) review, adds that the dose prescribed in countries where tianeptine is legal is 12.5 milligrams three times a day, and that FDA alerts reported U.S. product labels listing “hundreds to over 1,000 mg per dosage unit.” Published research on these harms is listed under Key Research Papers below.

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5. Where the Products Were Sold

The sales channel is the reason the 2024 letter went to retailers. The documents describe it this way:

• Gas stations and convenience stores. “Most consumers report purchasing this product at local gas stations or convenience stores across the country” (letter, 11 January 2024).
• Online and other retail. The product and other tianeptine products “are sold illegally online and in other retail locations” (letter). The November 2023 entry lists “gas stations, vape or smoke shops, or other locations” as well as online sales.
• Many product names. The May 2025 update states that tianeptine “is frequently available at convenience stores, gas stations, vape shops, and online retailers,” and lists several product names as examples; this page does not repeat them.

The letter also notes that “at least twelve states have banned the sale of tianeptine” as of January 2024. Those state laws are separate from the FDA’s action (section 7).

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6. The January and February 2024 Recalls

The FDA safety page records two recalls in early 2024, both voluntary actions by the companies selling the product:

• 23 January 2024. The product’s distributor “agreed to voluntarily recall all lots” of the product’s regular elixir, extra-strength elixir and tablet forms “to the consumer level” — meaning the recall reaches people who bought the product, not just stores and wholesalers. The FDA page states that consumers, distributors and retailers holding the products were to dispose of them or return them to the place of purchase.
• 15 February 2024. A second distributor of the same product “is also recalling their products.” The FDA notes that this company “has not issued a public notification to inform consumers of their recall,” and that its products carry the same product name but “the label and packaging might be slightly different,” in cherry, lemon and chocolate-vanilla flavors.

A recall is the removal of a product from sale and from people’s homes. In both cases the FDA page describes the recall as the company’s own action; neither was ordered by the FDA.

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7. What the Action Does Not Do

• Not a federal ban. The January 2024 letter is a request and a warning. It is not a rule or an order, and it does not by itself make selling tianeptine a federal crime.
• Not scheduling. The letter does not place tianeptine under the Controlled Substances Act; tianeptine was not a federally controlled substance as a result of this action. Scheduling is a separate process run by the DEA, which proposed it in July 2026 (section 9).
• Not the state bans. The letter reports that at least twelve states had banned tianeptine sales; those are state laws, not FDA actions.
• Not FDA-ordered recalls. The January and February 2024 recalls were voluntary company actions (section 6).
• Not limited to one product. Although the letter names one product, its request covers “any tianeptine-containing products.”

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8. Dates and Status as of 11 October 2026

• 21 November 2023 — FDA public safety alert on the product and on tianeptine in general (background).
• 11 January 2024 — FDA Health Fraud Branch letter urging all retailers to stop selling the product and any tianeptine-containing products.
• 23 January 2024 — FDA update: continued reports including seizures, loss of consciousness and death; first distributor agrees to a voluntary consumer-level recall of all lots.
• 15 February 2024 — FDA update: a second distributor of the same product also recalls.
• 8 May 2025 — FDA update stating that tianeptine is not approved, not GRAS and not a dietary ingredient, and that it is marketed as a research chemical, nootropic or supplement.
• 8 July 2026 — DEA notice of proposed rulemaking to place tianeptine in Schedule I (91 FR 42150, Docket No. DEA1596).
• 7 August 2026 — comment and hearing-request deadline on the DEA proposal.

Legal status as of 11 October 2026: the 2024 retailer letter was a completed, non-binding safety request, and the FDA’s warning to consumers remains posted on its safety page. Tianeptine remains unapproved for any medical use in the United States. Federal scheduling is proposed, not final: a check of the Federal Register through 11 October 2026 found the DEA’s July 2026 proposal but no final rule placing tianeptine in Schedule I.

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9. The 2026 DEA Proposal to Place Tianeptine in Schedule I

On 8 July 2026 the DEA, part of the Department of Justice, published a notice of proposed rulemaking, “Schedules of Controlled Substances: Placement of Tianeptine in Schedule I” (91 FR 42150–42158, FR Doc. 2026-13821, Docket No. DEA1596). The Controlled Substances Act sorts regulated drugs into five schedules; Schedule I is the most restrictive, for substances the government finds to have a high potential for abuse and no currently accepted medical use in treatment in the United States. If finalized, the notice says, the action “would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances” on anyone who manufactures, distributes, imports, exports, researches or possesses tianeptine.

How it got there. According to the notice, the DEA sent its data to HHS on 7 September 2023 with a request for a scientific and medical evaluation and a scheduling recommendation. On 18 July 2025 HHS recommended that tianeptine be controlled in Schedule I. The DEA then did its own eight-factor analysis, the review the law requires before a substance is scheduled.

What the notice reports. Among the findings it summarizes:

• Both the DEA and HHS analyses found that tianeptine “produces pharmacological effects that are similar to those produced by schedule II opioids, including morphine and fentanyl,” and that naloxone, the opioid-reversal drug, has reversed tianeptine overdose in some cases.
• The FDA concluded that tianeptine has no currently accepted medical use in treatment in the United States, noting that no state or locality has a program authorizing its medical use.
• Calls to U.S. poison centers about tianeptine rose from 11 in 2000–2013 to 207 in 2014–2017 (a CDC analysis), and a follow-up study found exposures rose 1,400 percent from 2015 to 2023; 40.1 percent of those exposures required medical admission, including 22.9 percent to a critical care unit.
• The National Forensic Laboratory Information System recorded 268 tianeptine encounters between March 2017 and February 2026.
• The HHS review lists states that had controlled or banned tianeptine sales: Alabama (2021), Arkansas (2022), Florida (2023), Georgia (2024), Indiana (2024), Kentucky (2023), Louisiana (2024), Maryland (2024), Michigan (2018), Minnesota (2023), Mississippi (2023), Ohio (2022), Oklahoma (2019), Tennessee (2022) and Virginia (2024). The notice adds that these bans “do not prohibit individuals from crossing state lines to buy tianeptine and have not limited the sale and availability of tianeptine online.”
• The notice cites the FDA’s May 2025 statement on daily doses of 50 to 10,000 mg in U.S. case reports.

Comments and hearing. Because scheduling is a formal rulemaking “on the record after opportunity for a hearing,” the notice let interested persons request a hearing as well as comment. Both deadlines were 7 August 2026. No final rule had appeared in the Federal Register as of 11 October 2026 (section 8).

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10. How the 2024 Action Fits Earlier and Later Steps

2018: the first FDA notices. The DEA’s 2026 notice records that “starting in November 2018, FDA issued its first of multiple notices to the public regarding the dangers of tianeptine,” because companies and websites were selling it without labeled warnings as a supplement to improve mental acuity or to treat opioid use disorder, pain and anxiety.

2023: the product alert. On 21 November 2023 the FDA issued its public safety alert about the specific elixir and tablet product (section 2), and in September 2023 the DEA asked HHS for a scheduling evaluation (section 9).

2024: the escalation. The 11 January 2024 letter moved from warning consumers to asking the retail trade itself to stop sales, and the two voluntary recalls followed within five weeks.

2025: the FDA’s restatement. The 8 May 2025 update set out the FDA’s position that tianeptine is not approved, not GRAS and not a dietary ingredient. Two months later, on 18 July 2025, HHS recommended Schedule I.

2026: proposed scheduling. The DEA’s July 2026 proposal would, if finalized, turn the federal response from warnings and voluntary recalls into controlled-substance law. Tianeptine was also mentioned at the FDA’s March 2026 public meeting on the scope of dietary supplement ingredients, where a consumer-advocacy speaker raised it as an example of a substance the FDA has stated is not a dietary ingredient (see the site’s dietary ingredient meeting page). A separate federal track on concentrated 7-hydroxymitragynine (7-OH) kratom products is described on the site’s 2025 and 2026 7-OH pages.

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11. Reporting Problems: What the FDA Documents List

The letter and the safety page list the channels the FDA uses to collect reports about tianeptine products:

• MedWatch. The letter asks consumers and retailers to report adverse events or side effects to FDA’s MedWatch Safety Information and Adverse Event Reporting Program, either through the MedWatch Online Voluntary Reporting Form or by downloading the form and faxing it to 1-800-FDA-0178.
• Poison Help. The FDA safety page lists Poison Help at 1-800-222-1222, which connects callers to their local poison center.
• Emergencies. The FDA safety page carries the line: “Need help now? Call 9-1-1 if the person is unconscious or has trouble breathing.”
• Retailer questions. The letter gives the Health Fraud Branch’s contact address, FDAAdvisory@fda.hhs.gov, for further information.

The CDC point quoted in section 4 — that tianeptine toxicity and withdrawal can resemble those of opioids — is one reason the DEA notice gives for under-recognition: it states that tianeptine “is not routinely included in toxicological analysis, and specialized testing may be required to positively identify this substance.” Questions about any medicine or supplement belong with a clinician.

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12. Primary Documents

1. U.S. Food and Drug Administration, Office of Regulatory Affairs, Health Fraud Branch (2024). Letter “To Whom it May Concern” urging retailers to stop selling tianeptine-containing products, 11 January 2024 — FDA letter (PDF), fda.gov/media/175628
2. U.S. Food and Drug Administration (2023–2025). FDA warns consumers not to purchase or use any tianeptine product due to serious risks. Drug Alerts and Statements page, entries dated 21 November 2023, 23 January 2024, 15 February 2024 and 8 May 2025 (content current as of 8 May 2025) — fda.gov tianeptine safety page
3. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Placement of Tianeptine in Schedule I; Notice of proposed rulemaking. Federal Register 91:42150–42158, 8 July 2026. Docket No. DEA1596 — FR Doc. 2026-13821

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Key Research Papers

1. El Zahran T, Schier J, Glidden E, Kieszak S, Law R, Bottei E, Aaron C, King A, Chang A (2018). Characteristics of tianeptine exposures reported to the National Poison Data System — United States, 2000-2017. MMWR Morbidity and Mortality Weekly Report 67(30):815-818 — PubMed PMID: 30070980
2. Quadir M, Rine NI, Badeti J, Hays HL, Michaels NL, Yang J, Smith GA (2025). Tianeptine exposures reported to United States poison centers, 2015-2023. Journal of Medical Toxicology 21(1):30-41 — PubMed PMID: 39724478
3. Springer J, Cubała WJ (2018). Tianeptine abuse and dependence in psychiatric patients: a review of 18 case reports in the literature. Journal of Psychoactive Drugs 50(3):275-280 — PubMed PMID: 29494783
4. Edinoff AN, Sall S, Beckman SP, Koepnick AD, Gold LC, Jackson ED, Wenger DM, Cornett EM, Murnane KS, Kaye AM, Kaye AD (2023). Tianeptine, an antidepressant with opioid agonist effects: pharmacology and abuse potential, a narrative review. Pain and Therapy 12(5):1121-1134 — PubMed PMID: 37453966
5. Ikeri K, Anderson A, Eyal F, Whitehurst R (2024). Neonatal opioid withdrawal syndrome following prenatal use of supplements containing tianeptine. Pediatrics 153(2):e2023062382 — PubMed PMID: 38213293
6. Anand A, Alessi MR, Toussi RA, Tian J, Raffoul JJ, Pratt N, Nero N, Weleff J (2026). Tianeptine misuse and addiction: a systematic review of withdrawal, toxicity, and clinical management. Drug and Alcohol Dependence 285:113196 — PubMed PMID: 42177839

What these papers report, from their abstracts: the CDC analysis found tianeptine exposure calls to poison centers rose during 2014–2017, with some effects mimicking opioid toxicity and many calls describing withdrawal. The 2015–2023 poison-center study counted 892 single-substance exposures, with withdrawal accounting for 22.5 percent. The 18-case review found doses up to 110 times the therapeutic dose (up to 4,125 mg a day), with marked euphoria and withdrawal driving continued use. The neonatal case describes a newborn with severe withdrawal after the mother used a tianeptine-containing supplement during pregnancy, noting that tianeptine is not detected by usual urine drug screens. The 2026 systematic review of 53 publications found that, among individual cases, half presented with withdrawal and 44 percent with overdose, and that 22 percent of patients in the retrospective series needed intensive care. The first two papers are the poison-center studies summarized in the DEA’s 2026 notice.

PubMed Topic Searches

1. PubMed: tianeptine poison center exposures
2. PubMed: tianeptine withdrawal and dependence
3. PubMed: tianeptine and the mu-opioid receptor

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Connections

• FDA Actions in 2024
• FDA and Regulation
• 7-OH Kratom Products: The 2026 Scheduling Steps
• FDA Moves Against Concentrated 7-OH Kratom Products (2025)
• FDA Public Meeting on What Counts as a Dietary Ingredient (2026)
• FDA and FTC Warn Sellers of Copycat Delta-8 THC Snacks (2024)
• FDA Finds Amanita Muscaria Unsafe in Food After Mushroom-Edible Illnesses (2024)
• Dangerous Supplements
• Memory and Brain Supplements
• Sedatives, Phenibut and Kratom
• Addiction and Substance Use Disorders
• Opioid Overdose
• Depression

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