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.
Previous Years: 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007
| Letter Issue Date | Firm Name | Issuing Office | Subject |
|---|---|---|---|
| 03/01/2021 | Ageless Global, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/18/2021 | Blossom Nature, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | ProHealth Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Dr. Garber’s Natural Solutions | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | FDC Nutrition Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | SANA Group LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Lifted Naturals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Enlifta, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Wholesome Wellness | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Mountain Peak Nutritionals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/18/2021 | Native Remedies dba Silver Star Brands | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 02/16/2021 | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 02/16/2021 | Dr. Paul's Lab | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/02/2021 | Clarke Pharmaceutical Manufacturing, Inc. | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| 01/22/2021 | American Global Health Group, LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| 01/14/2021 | Sage Moon Apothecary LLC | Division of Human and Animal Food Operations East I | New Drug/Misbranded |
| 01/12/2021 | Allimax Us | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 01/12/2021 | AusarHerbs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 01/06/2021 | Entia Biosciences, Inc | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| 01/04/2021 | Coco's Holistic Specialties & Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
*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.