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 | Company Name | Issuing Office | Subject |
|---|---|---|---|
| 04/01/2020 | Gaia's Whole Healing Essentials, LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 04/01/2020 | Homeomart Indibuy | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 04/01/2020 | Health Mastery Systems DBA Pure Plant Essentials | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/31/2020 | NeuroXPF | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/30/2020 | Bioactive C60/FullerLifeC60 LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/30/2020 | Halosense Inc. | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/30/2020 | JRB Enterprise Group Inc. DBA Anti Aging Bed | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/26/2020 | Corona-cure.com | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/26/2020 | Carahealth | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/20/2020 | Bulletproof 360 Inc | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 03/06/2020 | Quinessence Aromatherapy LTD | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | GuruNanda LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | Colloidal Vitality LLC/Vital Silver | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | Xephyr, LLC dba N-Ergetics | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | Vivify Holistic Clinic | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | The Jim Bakker Show | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 03/06/2020 | Herbal Amy Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 02/21/2020 | Warner Herb Co. | Office of Human and Animal Foods Operations-East | Unapproved New Drugs/Misbranded |
| 02/18/2020 | R-Garden LLC | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 02/12/2020 | Nature Essence Small Molecule Co., LTD | Division of Human and Animal Food Operations East V | Cosmetics/Adulterated/Misbranded |
| 01/17/2020 | GOJO Industries Inc | Division of Pharmaceutical Quality Operations III | Unapproved New Drugs/Misbranded |
| 01/13/2020 | Wave Miami LLC | Division of Pharmaceutical Quality Operations I | 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.