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 |
|---|---|---|---|
| 11/17/2025 | Mahita LLC dba PushMyCart | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 11/17/2025 | Handelnine Global, LLC dba Navafresh | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Adulterated/Misbranded |
| 11/17/2025 | Swift Digital Group LLC dba Swadesii | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 11/17/2025 | VarunKart Group LLC dba Organic Wellnesses | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 11/17/2025 | Distacart Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 11/13/2025 | 123Herbals | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 10/27/2025 | IBSPOT.com Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 09/18/2025 | Time Challenger Labs International, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 09/16/2025 | Stellalife, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 09/11/2025 | Blue Forest Farms, LLC | Human Foods Program | Adulterated Human Foods/Misbranded |
| 09/08/2025 | PureRawz | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 08/25/2025 | Green Vitality dba Gr33n | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | Homeopathic Educational Services dba Homeopathic Family Medicine | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | Mel Honey US | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | Supply Center USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | Trew Balance | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/25/2025 | Life Enthusiast Co-op | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Ophthalmic Drug Products |
| 08/06/2025 | Vacation Inc. | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 08/06/2025 | Kalani AB dba Kalani Sunwear | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 08/06/2025 | K & Care Organics | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 08/06/2025 | Fallien Cosmeceuticals Ltd. dba Fallene Ltd. | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 08/06/2025 | Supergoop! | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 08/01/2025 | Confer With | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/29/2025 | AlzClipp/Uni Uni | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/16/2025 | STNR Creations, LLC | Human Foods Program | Adulterated Human Foods/Misbranded |
| 07/09/2025 | Scope Health Inc | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/09/2025 | Revitalize Energy, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/09/2025 | Thea Pharma, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/09/2025 | EyeTech One, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 07/09/2025 | Covalent Medical | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 06/25/2025 | Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 06/25/2025 | My Smoke Wholesale | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 06/25/2025 | Hydroxie, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug/Human Food/Adulterated |
| 06/25/2025 | Relax Relief Rejuvenate Trading, LLC dba RRR Trading or EDP Kratom | Human Foods Program | Dietary Supplement/Adulterated |
| 06/25/2025 | Shaman Botanicals, LLC | Human Foods Program | Dietary Supplement/Adulterated |
| 06/25/2025 | 7Tabz Retail, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 06/25/2025 | Royal Diamond Imports, Inc. | Human Foods Program | Unapproved New Drug/Misbranded |
| 06/16/2025 | IndulgeRx Brands, Inc | Human Foods Program | New Drug/Misbranded |
| 05/30/2025 | Nefeteri Wellness | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |
| 05/30/2025 | Bio Wellness 444 LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 05/08/2025 | FishMoxFishFlex/Simple Pet Health LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Misbranded |
| 05/05/2025 | Supreme Rejuvenation, LLC | Center for Biologics Evaluation and Research | Unapproved New Drugs/Misbranded |
| 04/17/2025 | TKO Distribution, LLC | Human Foods Program | Adulterated Human Foods/Misbranded |
| 04/17/2025 | Amazon.com, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 04/15/2025 | Gluten Free Remedies LLC | Human Foods Program | Dietary Supplement/Misbranded |
| 04/07/2025 | Bailey’s Wellness, LLC dba Bailey’s CBD | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 04/07/2025 | Holista LLC dba HolistaPet | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 04/07/2025 | House of Alchemy LLC dba CBD Dog Health Hamet & Love LLC dba MycoDog | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 03/28/2025 | Mother Earth Minerals, Inc. | Human Foods Program | Unapproved New Drugs/Misbranded |
| 03/26/2025 | Naturista Store LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/25/2025 | Latro Inc. | Human Foods Program | Adulterated Human Foods/Misbranded |
| 03/20/2025 | BPI Labs, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/12/2025 | Kabana Skin Care | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/12/2025 | CoLabs Intl. Corp | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/12/2025 | Waxhead Sun Defense Company | Center for Drug Evaluation and Research (CDER) | OTC/Unapproved New Drug/Misbranded |
| 03/06/2025 | Pico IV Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/04/2025 | C & A Naturistics | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Julian Naya Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Fox Pharma LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Hyaluron Pen Store, LLC dba Glow Nest Beauty | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Filler Lux dba Filler Lux USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Vivid-Scientific LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 03/03/2025 | Amazon.com, Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 02/25/2025 | TKTX Numb Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug and Misbranded |
| 02/25/2025 | TKTX Numbing Cream USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 02/25/2025 | TKTX USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 02/25/2025 | TKTX Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
| 01/16/2025 | Mihon Corp. d/b/a VitalityVita and Boulla, LLC | 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.