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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

Biorica International Corp.

closeout letter: 

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)
 
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