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2018 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 Company Name Issuing Office Subject
11/08/2018 Guardian Pet Products Center for Veterinary Medicine Labeling/Unapproved New Animal Drug/Adulterated
11/08/2018 Avalon Packaging Denver District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded
11/07/2018 Jack B Goods Outlet Store Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
11/07/2018 MA Labs LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
10/31/2018 DynaPro International, Inc. Denver District Office Dietary Supplement/New Drug/Misbranded
10/30/2018 American Botanical Pharmacy San Francisco District Office Unapproved New Drugs/Misbranded
10/17/2018 No More Fleas Please, Inc. Dallas District Office New Animal Drug/Adulterated
10/10/2018 Original Living Coconut, LLC Kansas City District Office Food Labeling/Misbranded
09/18/2018 Rock Farm, LLC dba WholeFood Farmacy Cincinnati District Office Unapproved New Drugs/Misbranded
09/07/2018 Best Nutrition Products, Inc. San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded
09/06/2018 Adaptive Energy LLC Center for Food Safety and Applied Nutrition New Drug/Misbranded
09/04/2018 Chillin Mix Kratom Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
09/04/2018 Mitra Distributing Inc. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
08/28/2018 Celletech, Ltd Minneapolis District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded
08/15/2018 Healthy Healing dba Crystal Star Minneapolis District Office New Drug/Labeling/Misbranded
07/18/2018 Hawaiian Organic Noni, LLC Los Angeles District Office Labeling/False & Misleading Claims/Misbranded
07/13/2018 GC Natural Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded
07/12/2018 www.poppyseedwash.com Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
07/03/2018 AniCell Biotech Los Angeles District Office Unapproved New Animal Drug/Adulterated
06/26/2018 American Chinese Medicine Association Detroit District Office New Drug/Misbranded
06/07/2018 Up Inya Gear Center for Food Safety and Applied Nutrition New Drug/Misbranded
06/06/2018 The Health Management Group Inc. Cincinnati District Office CGMP/Dietary Supplement/Adulterated/Misbranded
05/18/2018 Kratom Spot Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
05/18/2018 Revibe, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
05/18/2018 Pharmacy Direct, PDU Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
05/18/2018 Front Range Kratom Center for Food Safety and Applied Nutrition Unapproved New Drug/Misbranded
05/18/2018 Sunergized LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
05/18/2018 Napa Valley Bioscience Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
04/25/2018 Baker's Best Health Products, Inc. Chicago District Office Unapproved New Drugs/Misbranded
03/30/2018 Vital Hierbas Naturales Corporation Chicago District Office New Drug/Misbranded
03/30/2018 Ozark Country Herbs Dallas District Office Unapproved New Drugs/Misbranded
03/29/2018 South Texas Botanicals Dallas District Office Unapproved New Drugs/Misbranded
03/21/2018 Secret Garden of Health & Healing, LLC Denver District Office Unapproved New Drugs/Misbranded
03/13/2018 Biotek, Inc. Denver District Office Unapproved New Drugs/Misbranded
02/23/2018 PA Constans - Minnesota Emu Minneapolis District Office New Drug/Labeling/Misbranded
02/06/2018 Reishi D. International, Inc. San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded
02/05/2018 Infant Acid Reflux Solutions LLC Los Angeles District Office Unapproved New Drugs/Misbranded
01/31/2018 Long Life Unlimited Cincinnati District Office New Drug/Misbranded
01/24/2018 Young Health Products Dallas District Office New Drug/Misbranded
01/11/2018 Guna Inc. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 U4Life LLC dba Mitadone Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 Choice Detox Center, Inc. dba Nofeel Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 Opiate Freedom Center Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 Healthy Healing dba Crystal Star Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 Medicus Holistic Alternatives LLC Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 TaperAid Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 King Bio Inc. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 CalmSupport.com, LLC Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 NutraCore Health Products Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018 Soothedrawal, Inc. Center for Food Safety and Applied Nutrition Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/10/2018 USA Labs AKA Power Source Distributors, Inc AKA USA Sport Cincinnati District Office New Drug/Misbranded
01/05/2018 Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. Seattle District Office New Drug/Labeling/Misbranded
*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.