FDA Alerts & Actions

Recent FDA consumer alerts and enforcement actions for products commonly sold in gas stations and vape shops. References are listed below (no links). Dates emphasize 2024–present where available.

Last updated: October 21, 2025
Note: FDA alerts do not require proof of causation; they flag safety risks, adulteration, misbranding, or unapproved status. Many products below are not FDA-approved drugs or lawful dietary supplements.
Kratom • Mitragynine

Kratom

  • Jul 2024: FDA safety alert advising consumers not to use a specific liquid kratom extract (OPMS Black) after reports of serious adverse events and a death. (Ref 1)
  • Ongoing: FDA public-health page reiterates no FDA-approved kratom products; risks include liver toxicity, seizures, SUD. (Ref 2)
  • 2025: Enforcement communications regarding 7-hydroxymitragynine (7-OH) in marketed products. (Ref 3)

Status: Multiple FDA warnings/consumer updates.

Unapproved Antidepressant

Tianeptine

  • Jan 2024: Urgent message on recall of “Neptune’s Fix” products associated with poisonings and undeclared ingredients. (Ref 4)
  • May 2025: FDA warns consumers to avoid any tianeptine product due to serious risks (overdose, death). (Ref 5)
  • Ongoing: FDA consumer page detailing harms and lack of approval. (Ref 6)

Status: Multiple FDA consumer warnings and recalls.

GABA Analog

Phenibut

  • Updated 2023–2024: FDA states phenibut is not a lawful dietary ingredient; products marketed as supplements are misbranded/adulterated. (Ref 7)
  • FDA has taken enforcement actions (warning letters) against firms selling phenibut as a supplement. (Ref 7)

Status: Policy/enforcement page; no consumer “alert” headline, but clear prohibition.

Cannabinoids • Delta-8/Extracts

Delta-8 THC & Other THC Extracts

  • 2022–2024: FDA consumer updates & joint FDA/FTC letters against companies selling delta-8 edibles that mimic snacks/candy; numerous adverse event reports. (Refs 8–9)
  • 2019–ongoing: THC vaping/extract contaminants associated with EVALI; FDA addresses risks of additives/unknown by-products. (Ref 10)

Status: Ongoing warnings; multiple enforcement letters.

Mushroom • Muscimol/Ibotenic

Amanita muscaria

  • Dec 2024: FDA constituent update/industry reminder: Amanita muscaria and its extracts are not authorized for use in conventional foods; such products are adulterated. (Ref 11)
  • 2025: Warning letters citing Amanita products as adulterated/misbranded. (Ref 12)

Status: Advisory + enforcement posture.

Inhalant

Nitrous Oxide

  • Jun 2025: FDA advisory: do not inhale nitrous oxide products (chargers/tanks); serious harms and deaths reported. (Ref 13)
  • Emphasis on food-use only (whipped cream) and risks from recreational inhalation. (Ref 13)

Status: Formal consumer advisory.

Alkyl Nitrites

“Poppers” (Amyl/Alkyl Nitrites)

  • FDA consumer update warns that ingesting or inhaling nitrite “poppers” can cause severe injury or death; ongoing safety messaging. (Ref 14)
  • Products marketed for non-medical use are dangerous; reports include methemoglobinemia, hypotension, loss of consciousness. (Ref 14)

Status: FDA consumer update page.

References (FDA publications; no links)

  1. FDA. Safety Alert: Consumers advised not to use “OPMS Black Liquid Kratom Extract.” July 2024.
  2. FDA. FDA and Kratom — Public Health Focus Page. Ongoing.
  3. FDA. Press/Enforcement: Warning letters regarding products containing 7-hydroxymitragynine (7-OH). 2025.
  4. FDA. Urgent Message regarding recalled “Neptune’s Fix” products. January 31, 2024.
  5. FDA. Drug Safety: FDA warns consumers not to purchase or use any tianeptine product due to serious risks. May 2025.
  6. FDA. Consumer Update: “Tianeptine — linked to serious harm, overdoses, death.” Updated 2025.
  7. FDA. Phenibut in Dietary Supplements — Not a lawful dietary ingredient; misbranding/adulteration policy. 2023–2024.
  8. FDA/FTC. Joint warning/enforcement communications on delta-8 THC food products resembling candy/snacks. 2022–2024.
  9. FDA. Consumer Updates on Delta-8 THC: risks, adverse events, and labeling concerns. 2021–2024.
  10. FDA. Cannabis/CBD/THC Regulatory Pages and EVALI-related communications. 2019–ongoing.
  11. FDA. Constituent Update/Industry Reminder: Amanita muscaria/muscimol products are not authorized for conventional foods. December 18, 2024.
  12. FDA. Warning Letters citing Amanita muscaria products as adulterated/misbranded. 2025.
  13. FDA. Advisory: Do not inhale nitrous oxide products (chargers/tanks). June 4, 2025.
  14. FDA. Consumer Update: Nitrite “poppers” can cause severe injury or death. Ongoing safety page.

Compiled from FDA consumer updates, advisories, press announcements, and enforcement pages. For precise URLs, we can add linked citations if you want a hyperlinked version.

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