For Consumers

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.

Previous Years: 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007

Letter Issue DateCompany NameIssuing OfficeSubject
10/17/2018No More Fleas Please, Inc.Dallas District OfficeNew Animal Drug/Adulterated
10/10/2018Original Living Coconut, LLCKansas City District OfficeFood Labeling/Misbranded
09/18/2018Rock Farm, LLC dba WholeFood FarmacyCincinnati District OfficeUnapproved New Drugs/Misbranded
09/07/2018Best Nutrition Products, Inc.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
09/06/2018Adaptive Energy LLCCenter for Food Safety and Applied NutritionNew Drug/Misbranded
09/04/2018Chillin Mix KratomCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
09/04/2018Mitra Distributing Inc.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
08/28/2018Duy Drugs Inc.San Juan District OfficeDietary Supplement/New Drug/Misbranded
08/28/2018Celletech, LtdMinneapolis District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
08/15/2018Healthy Healing dba Crystal StarMinneapolis District OfficeNew Drug/Labeling/Misbranded
07/18/2018Hawaiian Organic Noni, LLCLos Angeles District OfficeLabeling/False & Misleading Claims/Misbranded
07/13/2018GC NaturalLos Angeles District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
07/12/2018www.poppyseedwash.comCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
07/03/2018AniCell BiotechLos Angeles District OfficeUnapproved New Animal Drug/Adulterated
06/26/2018American Chinese Medicine AssociationDetroit District OfficeNew Drug/Misbranded
06/07/2018Up Inya GearCenter for Food Safety and Applied NutritionNew Drug/Misbranded
06/06/2018The Health Management Group Inc.Cincinnati District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/18/2018Kratom SpotCenter for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
05/18/2018Revibe, Inc.Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
05/18/2018Pharmacy Direct, PDUCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
05/18/2018Front Range KratomCenter for Food Safety and Applied NutritionUnapproved New Drug/Misbranded
05/18/2018Sunergized LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
05/18/2018Napa Valley BioscienceCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
04/25/2018Baker's Best Health Products, Inc.Chicago District OfficeUnapproved New Drugs/Misbranded
03/30/2018Vital Hierbas Naturales CorporationChicago District OfficeNew Drug/Misbranded
03/30/2018Ozark Country HerbsDallas District OfficeUnapproved New Drugs/Misbranded
03/29/2018South Texas BotanicalsDallas District OfficeUnapproved New Drugs/Misbranded
03/21/2018Secret Garden of Health & Healing, LLCDenver District OfficeUnapproved New Drugs/Misbranded
03/13/2018Biotek, Inc.Denver District OfficeUnapproved New Drugs/Misbranded
02/23/2018PA Constans - Minnesota EmuMinneapolis District OfficeNew Drug/Labeling/Misbranded
02/06/2018Reishi D. International, Inc.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
02/05/2018Infant Acid Reflux Solutions LLCLos Angeles District OfficeUnapproved New Drugs/Misbranded
01/31/2018Long Life UnlimitedCincinnati District OfficeNew Drug/Misbranded
01/24/2018Young Health ProductsDallas District OfficeNew Drug/Misbranded
01/11/2018Guna Inc.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018U4Life LLC dba MitadoneCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018Choice Detox Center, Inc. dba NofeelCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018Opiate Freedom CenterCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018Healthy Healing dba Crystal StarCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018Medicus Holistic Alternatives LLCCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018TaperAidCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018King Bio Inc.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018CalmSupport.com, LLCCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018NutraCore Health ProductsCenter for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/11/2018Soothedrawal, Inc.Center for Food Safety and Applied NutritionFinished Pharmaceuticals/Unapproved New Drug/Misbranded
01/10/2018USA Labs AKA Power Source Distributors, Inc AKA USA SportCincinnati District OfficeNew Drug/Misbranded
01/05/2018Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.Seattle District OfficeNew 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.

Page Last Updated: 10/30/2018
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