2021 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.
| Letter Issue Date | Firm Name | Issuing Office | Subject |
|---|---|---|---|
| 12/29/2021 | Varigard, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 12/09/2021 | Wholly Liquid Nutritional Supplements LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded |
| 12/01/2021 | VitaStik, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 12/01/2021 | VitaCig, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 12/01/2021 | NV Nutrition, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 12/01/2021 | Vitamin Vape, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 12/01/2021 | Eagle Energy USA, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 11/18/2021 | Saffron Health Sciences | Division of Human and Animal Food Operations East II | New Drug/Misbranded |
| 11/09/2021 | Synaptent, LLC | Office of Human and Animal Food Operations-East 6 | New Drug/Misbranded |
| 10/21/2021 | Dominant Nutrition LLC formerly 8 Weeks Out Labs | Office of Human and Animal Foods West | Dietary Supplement/Adulterated |
| 10/13/2021 | Organa International Corp. | Office of Human and Animal Food Operations Division West 4 | Unapproved New Drugs/Misbranded |
| 10/13/2021 | Quicksilver Scientific | Office of Human and Animal Food Operations Division West 4 | New Drug/Misbranded |
| 09/28/2021 | Strategia Project Management, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 09/22/2021 | Supplement Science Corp. d/b/a Condemned Labz | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| 09/22/2021 | The Camel Milk Co. LLC dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
| 09/20/2021 | ICA Health, LLC/Future Formulations, LLC | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
| 09/13/2021 | Furley Bioextracts SDN BHD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 09/10/2021 | Holographic Health, Inc. | Division of Human and Animal Food Operations East V | New Drug/Misbranded |
| 09/07/2021 | McDaniel Water, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Radhanite, LLC d/b/a Curalife Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Aceva, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Ar-Rahman Pharm LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Lysulin, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Phytag Labs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Nuturna International LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Pharmaganics LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Live Good Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Metamune Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 09/07/2021 | Holistic Healer & Wellness Center, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
| 08/31/2021 | New York Nutrition Company / American Metabolix | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| 08/26/2021 | Fibromyalgia Treatment Group - FTG, LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| 08/24/2021 | Invisi Smart Technologies UK LTD | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 |
| 08/19/2021 | Mahita, LLC dba PushMyCart | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 08/11/2021 | Je Dois Lavoir LLC | Division of Pharmaceutical Quality Operations IV | Unapproved New Drugs/Misbranded |
| 08/10/2021 | Secret of the Islands | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 08/06/2021 | Genesis Nutrition Ultra Slim dba Genesis Ultra Slim | Office of Pharmaceutical Quality Operations, Division II | Unapproved New Drugs/Misbranded |
| 08/03/2021 | Blue Willow Biologics | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/29/2021 | Lepu Medical Technology -Beijing- Co., Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/28/2021 | Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/26/2021 | Vivera Pharmaceuticals, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/26/2021 | Vivera Pharmaceuticals, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/23/2021 | TeaTaze, LLC | Office of Human and Animal Food- West Division II | New Drug/Misbranded |
| 07/22/2021 | MB Solutions, LLC/BioSpectrum CBD | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 07/20/2021 | Jordan’s Crossing Herbal Connections | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/20/2021 | Chill6 | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| 07/20/2021 | Brilliant Enterprises LLC | Office of Human and Animal Food Operations Division- East 6 | Unapproved New Drugs/Misbranded |
| 07/09/2021 | USH Diagnostics, Inc./covidinstanttest.net | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/09/2021 | Biopolygen Corp. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/08/2021 | 3RD Day Nutraceuticals, LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded |
| 07/07/2021 | Halodine, LLC | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 07/01/2021 | Phoenix Nutritionals, Inc. | Office of Human and Animal Food Operations-West Division 5 | New Drug/Misbranded |
| 07/01/2021 | Biomedical Research Laboratories, LLC | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded |
| 06/23/2021 | Great Healthworks, Inc. | Office of Human and Animal Food Operations, Division IV East | Unapproved New Drugs/Misbranded |
| 06/22/2021 | Pacific Center of Health/Pacific Center of Health & Acupuncture | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/10/2021 | Natural Hope Herbals, LLC | Division of Human and Animal Food Operations East II | New Drug/Misbranded |
| 06/10/2021 | Innova Medical Group, Inc. | Center for Devices and Radiological Health | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/07/2021 | Flora Inc | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| 05/27/2021 | Fresh Nutrition Inc | Office of Human and Animal Food Operations –West Division 5 | Unapproved New Drugs/Misbranded |
| 05/27/2021 | OCLO LLC/OCLO Nanotechnology Science | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/26/2021 | JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health | Office of Human and Animal Food Operations- West Division 5 | New Drug/Misbranded |
| 05/24/2021 | Beauty & Spa Concepts, DBA Beenefits | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/24/2021 | Everything Health LLC | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/20/2021 | NS Products, Inc. | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 05/20/2021 | Fertility Nutraceuticals LLC | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 05/20/2021 | EU Natural Inc. | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 05/20/2021 | LeRoche Benicoeur dba ConceiveEasy | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 05/20/2021 | Sal Nature LLC/FertilHerb | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 05/19/2021 | BGP, LLC | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/10/2021 | Great Lakes Gelatin Company | Office of Human and Animal Food Operations East-VI | New Drug/Misbranded |
| 05/06/2021 | Disinfect & Shield | Center for Drug Evaluation and Research | Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/06/2021 | Covalon Technologies Inc. | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/04/2021 | Baltimore Beauty Security Square Mall | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/29/2021 | Crown Wellness, Inc | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 04/27/2021 | NeuroHydrate LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded |
| 04/21/2021 | DRF LLC | Office of Human and Animal Foods Operations- West Division | New Drug/Misbranded |
| 04/21/2021 | North American Hirudin Biotech Products Inc. | Office of Regulatory Affairs | New Drug/Misbranded |
| 04/15/2021 | Molecular BioLife International, Inc. | Office of Human and Animal Foods West Division II | New Drug/Misbranded |
| 04/13/2021 | Trinity Natural Health & Pain Management, Inc. | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/13/2021 | Orphic Nutrition | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded |
| 04/13/2021 | Anytime COVID Test LLC | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/08/2021 | Groupe Cyrenne Inc. dba HomeoAnimal | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 04/07/2021 | Allure Imports | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/07/2021 | About Mineral | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/07/2021 | Unived Inc | Office of Human and Animal Food Operations- West Division 5 | New Drug/Misbranded |
| 04/06/2021 | Sethi Laboratories | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/01/2021 | Natural Adventure, LLC | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/30/2021 | Immune & Genetics Protocols, LLC | Office of Human and Animal Food Operations, East Division IV | New Drug/Misbranded |
| 03/19/2021 | Lipotriad LLC | Division of Human and Animal Food Operations East II | New Drug/Misbranded |
| 03/25/2021 | Ikcon Investments, Inc dba Ikcon Medical | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/24/2021 | Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/18/2021 | Block Scientific | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 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) |
| 02/19/2021 | Richardson Nutritional Center, LLC/Nutriseeds, Inc. | Office of Human and Animal Food Operations-West Division 5 | New Drug/Misbranded |
| 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.