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 |
|---|---|---|---|
| 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 |
| 02/28/2024 | Native Salts LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 02/22/2024 | 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 |
| 02/06/2024 | Global Life Technologies Corp. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/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.