Warning Letters - Health Fraud
Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. For all FDA Warning Letters, click here.
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| Letter Issue Date | Firm Name | Issuing Office | Subject |
|---|---|---|---|
| 12/10/2024 | Veronvy | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 12/10/2024 | Xcel Research LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 12/10/2024 | Prime Vitality, Inc. dba Prime Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 12/10/2024 | Summit Research Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 12/10/2024 | Swisschems | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 10/24/2024 | Fancy Drops Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 09/13/2024 | Far East Summit LLC | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
| 09/11/2024 | Quality CDMO, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 08/30/2024 | Root Bioscience Brands, LLC dba Naternal | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 08/14/2024 | Graceleigh, Inc. dba Sammy’s Milk | Division of Human and Animal Food Operations West V | Food Labeling/Misbranded |
| 08/27/2024 | Everymarket Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 08/27/2024 | SoloVital | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 08/27/2024 | MexHealth LLC d/b/a Al Natural E-Shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/25/2024 | Matte Beauty | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/25/2024 | Walmart, Inc. | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/25/2024 | Repare Skincare | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/25/2024 | ISIS.GOLD | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/25/2024 | Skin Beauty Solutions | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/25/2024 | Amazon.com, Inc. | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/15/2024 | Earthly Hemps | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/15/2024 | Life Leaf Medical CBD Center | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/15/2024 | Mary Jane's Bakery Co. LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/15/2024 | Shamrockshrooms.com | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/15/2024 | Grow God, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/15/2024 | Hippy Mood | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing |
| 07/09/2024 | Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drugs |
| 07/02/2024 | Premier Manufacturing Products, LLC | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drug |
| 04/18/2024 | APG SEVEN, INC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| 03/25/2024 | TKTX Company | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/25/2024 | SeeNext Venture, Ltd. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/25/2024 | Dermal Source, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/25/2024 | Sky Bank Media, LLC dba Painless Tattoo Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/25/2024 | Indelicare DBA INKEEZE | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/25/2024 | Tattoo Numbing Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/13/2024 | Skull Smash LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/08/2024 | Spirochaete Research Labs, LLC aka Scitus Laboratory Products | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 03/01/2024 | Carbon Fire, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |
| 02/28/2024 | Native Salts LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 02/22/2024 | Innovative Formulations, LLC dba Insane Labz | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 02/13/2024 | Salvacion USA Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 02/07/2024 | US Chem Labs | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| 02/07/2024 | Synthetix Inc. DBA Helix Chemical Supply | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 02/06/2024 | Global Life Technologies Corp. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 01/24/2024 | Sambrosa Care Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.