2022 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 |
|---|---|---|---|
| 12/05/2022 | Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated Human Foods |
| 11/16/2022 | Infusionz, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/16/2022 | Newhere Inc dba CBDFX | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/16/2022 | 11-11-11 Brands | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/16/2022 | Naturally Infused LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/16/2022 | CBD American Shaman, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/16/2022 | Essential Elements | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/16/2022 | iwi | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/16/2022 | BergaMet North America LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/16/2022 | Healthy Trends Worldwide, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/16/2022 | Chambers' Apothecary | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/16/2022 | Anabolic Laboratories Inc | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/14/2022 | The Truth Company, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/14/2022 | Calroy Health Sciences, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/07/2022 | Todos Medical Ltd aka Todos Medical USA Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 11/01/2022 | Alternative Health Distribution LLC d/b/a CannaAid | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| 10/28/2022 | Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 10/28/2022 | Latin Foods Market | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 10/28/2022 | Walmart Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 10/24/2022 | Lakpura LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 09/23/2022 | Saffron USA LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded |
| 09/23/2022 | Muscle Sports Products, LLC | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| 09/20/2022 | South Pork Ranch Equipment LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| 08/15/2022 | Office of Human and Animal Food Operations East Division 6 | Unapproved New Drugs/Misbranded | |
| 08/04/2022 | Office of Human and Animal Food- West Division II | Unapproved New Drugs/Misbranded | |
| 08/04/2022 | FluxxLab LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 08/04/2022 | Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 08/04/2022 | JB Exchange Inc./Justified Laboratories | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 08/04/2022 | Ariella Naturals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 07/29/2022 | Deggeh Foods, Inc. | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded |
| 07/05/2022 | Living Foods LLC | Office of Human and Animal Food- West Division II | Unapproved New Drugs/Misbranded |
| 07/01/2022 | Shopaax.com | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated |
| 07/01/2022 | MKS Enterprise, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Interstate Commerce/Food/Adulterated |
| 07/01/2022 | Thirsty Run LLC / US Royal Honey LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Internet Marketing of Unapproved and Misbranded Drugs |
| 07/01/2022 | 1am USA Incorporated dba Pleasure Products USA | Center for Food Safety and Applied Nutrition (CFSAN) | Internet Marketing of Unapproved and Misbranded Drugs |
| 06/30/2022 | Herbsens Botanicals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 06/30/2022 | Klarity Kratom | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 06/30/2022 | Kratom Exchange | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 06/30/2022 | Omni Consumer Products LLC d/b/a YoKratom | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 06/30/2022 | MONQ, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 06/14/2022 | H2 Beverages, Inc. | Division of Human and Animal Food Operations West III | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/10/2022 | Young Living Essential Oils Corporate | Office of Human and Animal Food Operations – West Division 4 | New Drug/Misbranded |
| 06/08/2022 | New Sun Inc. | Office of Human and Animal Foods- East Division 3 | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/26/2022 | Hope Botanicals, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/26/2022 | Plantacea, LLC dba Kahm | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/26/2022 | Haniel Concepts, Inc. DBA Free State Oils, LLC | Center for Veterinary Medicine | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/26/2022 | Golden Lab LLC | Office of Human and Animal Food Operations East Division IV | Unapproved New Drugs/Misbranded |
| 05/19/2022 | Santhigram Kerala Ayurvedic Co. of U.S., Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs |
| 05/19/2022 | Ayuryoga, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drug |
| 05/16/2022 | Equine Podiatry Solutions, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 05/04/2022 | BioMD Plus LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | M Six Labs, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | Kingdom Harvest | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | Delta 8 Hemp | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | ATLRx, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 04/20/2022 | C R Supplements, LLC | Office of Human and Animal Food Operations – West Division 6 | Unapproved New Drugs/Misbranded |
| 04/19/2022 | Kleenhanz, LLC | Center for Drug Evaluation and Research | CDER | Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/13/2022 | Elements Brands Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Skin Authority, L.L.C. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | AMBI Enterprises LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Genomma Lab USA, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | M & M Beauty and Wellness, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | True Earth Health Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | SkinPro | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Skin PS Brands | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Clinical Formula LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Dr. Thomas Balshi/Intilight | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Ultimark Products | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/06/2022 | Sensory Cloud, Inc | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/05/2022 | CofixRx, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Greenway Herbal Products LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Cureganics | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Functional Remedies, LLC D/B/A Synchronicity Hemp Oil | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | UPSY LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Heaven’s Organic LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | CBD Social | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Nature's Highway | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/25/2022 | Iodine Products Inc | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/24/2022 | Applied Biological Laboratories Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| 03/15/2022 | Honey Feast, Inc. | Office of Human and Animal Food Operations East Division IV | New Drug/Misbranded |
| 03/15/2022 | Iotech International, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/10/2022 | Soda Pharm | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/07/2022 | Viraldine, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/23/2022 | Princess Lifestyles, LLC | Office of Human and Animal Food Operations –West Division 5 | Unapproved New Drugs/Misbranded |
| 02/17/2022 | Vital Health & Wellness | Office of Human and Animal Foods Operations-East V | New Drug/Misbranded |
| 02/11/2022 | Rena's Organic | Office of Human and Animal Foods Division 4 East | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 02/09/2022 | Bea Lydecker’s Naturals, Inc. | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 02/04/2022 | Crystal Clear Supplements | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 02/03/2022 | Pharmacy2Home/LandiCom Holding LTD | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/01/2022 | New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 01/19/2022 | Glenn Burkett Naples Corporation | Office of Human and Animal Food Operations East Division IV | Unapproved New Drugs/Misbranded |
| 01/03/2022 | Amcyte Pharma, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product 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.