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 |
|---|---|---|---|
| 04/01/2021 | Natural Adventure, LLC | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/19/2021 | Lipotriad LLC | Division of Human and Animal Food Operations East II | New Drug/Misbranded |
| 03/16/2021 | Anna Health, LLC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| 03/16/2021 | Duoc Thao Tre Xanh, LLC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded |
| 03/15/2021 | BioLyte Laboratories, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/15/2021 | Honest Globe, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/12/2021 | Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/05/2021 | CAMA Wellness Center/IodoRios Company, LLC | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Shenzhen Sunell Technology Corporation | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Workswell Group s.r.o. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Westminster International Ltd | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | CreativeStar Solutions | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Thermavis | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Opgal Optronic Industries Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Thermoteknix System Limited | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Omnisense Systems Pte Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Omega Engineering Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Dubak Electrical Group | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | EnMed MicroAnalytics, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/04/2021 | Orvic dba Webstore-USA | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/01/2021 | Cannafyl | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 03/01/2021 | Ageless Global, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/26/2021 | Orvic dba Webstore-USA | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/18/2021 | Mercola.com, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/18/2021 | B4B Corp. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/18/2021 | SafaLab, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | 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 |
| 01/25/2021 | PYRLess Group, LLC dba Dr. Fitt | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 01/25/2021 | EnMed MicroAnalytics, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 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.