2023 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 |
|---|---|---|---|
| 12/23/2023 | East Fork Cultivars | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 12/20/2023 | Hua Da Trading, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 12/20/2023 | Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 12/20/2023 | Samuel Rodriguez dba KiloKennelzz | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| 12/05/2023 | Ambaya Gold Health Products, LLC | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded |
| 11/13/2023 | Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 10/30/2023 | Dexterity Health, LLC DBA Zazzee Naturals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug |
| 10/18/2023 | Natural Relief Inc. | Division of Human and Animal Food Operations East V | Unapproved New Drugs/Misbranded |
| 10/04/2023 | Embryll Life Sciences, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
| 09/25/2023 | Shot of Joy LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | CVS Health | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | Boiron, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | DR Vitamins, LLC dba DR Vitamin Solutions | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | TRP Company, Inc | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | Natural Ophthalmics, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | Walgreens Boots Alliance, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 09/11/2023 | OcluMed LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/23/2023 | Osmosis, LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded |
| 08/18/2023 | Molluscumaway LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/18/2023 | Amazon.com, Inc | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/18/2023 | Nature’s Innovation, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/18/2023 | Thrasio, LLC D/B/A ZymaDerm | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/18/2023 | MolluscumRx, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/18/2023 | Walmart, Inc | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/16/2023 | Essential Research, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 08/09/2023 | CalmCo LLC previously named Ketomi LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/09/2023 | ALVA-AMCO Pharmacal Companies, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 08/08/2023 | Source-Omega LLC | Division of Human and Animal Food Operations East V | New Drug/Misbranded |
| 08/04/2023 | Day Light Nutrition | Division of Human and Animal Food Operations West II | New Drug/Misbranded |
| 08/04/2023 | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | |
| 08/01/2023 | Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc. | Division of Human and Animal Food Operations East VI | Unapproved New Drugs/Misbranded |
| 07/21/2023 | Gadget Island, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 07/20/2023 | Wise Women’s Choice | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 07/18/2023 | Koi CBD, LLC | Division of Human and Animal Food Operations West V | Adulterated Human Foods/Misbranded |
| 07/03/2023 | Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs |
| 06/22/2023 | Suprimo Imports | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 06/12/2023 | Warrior Labz SARMS | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 06/02/2023 | Hekma Center, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drugs/Dietary Supplements/Food Labeling/Misbranded |
| 06/01/2023 | A&Z Pharmaceutical, Inc. | Division of Human and Animal Food Operations East I | New Drug/Misbranded |
| 05/18/2023 | Champaklal Maganlal Homeo Pharmacy Private Limited | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 05/12/2023 | H.E.A.L. Marketplace | Division of Human and Animal Food Operations East III | New Drug/Misbranded |
| 05/03/2023 | iSlim, LLC | Division of Pharmaceutical Quality Operations II | Unapproved New Drugs/Misbranded |
| 05/03/2023 | Bee Healthy Farms LLC | Division of Human and Animal Food Operations West I | Interstate Commerce/Food/Adulterated |
| 04/27/2023 | Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 04/27/2023 | EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
| 04/23/2023 | Nose Slap LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 04/19/2023 | Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 04/07/2023 | STPCA Inc. dba Sun Ten Laboratories | Division of Human and Animal Food Operations West V | Unapproved New Drugs/Misbranded |
| 04/06/2023 | SCS Direct, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated |
| 04/04/2023 | ByPro Nutrition LLC | Division of Human and Animal Food Operations West II | Unapproved New Drugs/Misbranded |
| 03/08/2023 | Spartan Enterprises Inc. dba Watershed Wellness Center | Division of Human and Animal Food Operations East VI | Unapproved New Drugs/Misbranded |
| 03/07/2023 | Herbal Vitality, Inc. | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded |
| 02/03/2023 | Jackson Health & Wellness Clinic | Division of Human and Animal Food Operations East V | New Drug/Misbranded |
| 01/30/2023 | Old Tiles Wallpaper, LLC DBA Old Tiles Decor | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/30/2023 | Monkeypox-treatment.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/30/2023 | Noble Elements, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/30/2023 | Organic Heirloom Plants | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/30/2023 | Dr. Green Mom, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/26/2023 | Desert Defense, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products |
| 01/05/2023 | PharmaCanna | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |