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: 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007

Letter Issue DateCompany NameIssuing OfficeSubject
07/18/2016Ageless AestheticsDenver District OfficeNew Drug/Labeling/False & Misleading Claims
07/15/2016Annemarie Gianni Skin Care LLCNew England District OfficeNew Drug/Labeling/Misbranded
07/15/2016Karen RocheNew England District OfficeNew Drug/Misbranded
06/30/2016Mc-Cor, LLCSan Juan District OfficeNew Drug/Misbranded
06/03/2016Focus Laboratories, Inc.Dallas District OfficeMedical Foods and New Drug Labeling/Internet Claims/Misbranded
06/02/2016Steroid BazaarCenter for Drug Evaluation and ResearchUnapproved New Drugs / Misbranded
06/02/2016Shop AnabolicsCenter for Drug Evaluation and ResearchUnapproved New Drugs / Misbranded
05/13/2016Rocky Fork Formulas IncCincinnati District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/10/2016Reviva Labs IncNew Jersey District OfficeUnapproved New Drugs/Adulterated
05/06/2016Economax LLCNew York District OfficeUnapproved New Drugs/Misbranded
04/28/2016Macular HealthNew Orleans District OfficeNew Drug/Misbranded
04/20/2016Crescent Health Center, IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
04/14/2016Hollywood Skincare International Inc.Florida District OfficeUnapproved New Drugs/Misbranded
04/14/2016Ultimate Weight Loss Co.Florida District OfficeUnapproved New Drugs/Misbranded
03/31/2016Chaotic LabzCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016Line One Nutrition, IncCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016m4 Nutrition Companies LLCCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016NutraClipse, IncCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016Swagger SuppsCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016Total Body NutritionCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016Xcel Sports Nutrition, LLCCenter for Food Safety and Applied NutritionMethylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/17/2016Rx Vitamins, IncNew York District OfficeUnapproved New Drugs/Misbranded
03/16/2016Black Onyx World LLC dba Alikay NaturalsFlorida District OfficeUnapproved New Drugs/Misbranded
03/07/2016VitaCare Pharma, LLCNew Jersey District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
03/03/2016Universal Formulas, Inc.Detroit District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
02/25/2016Herbal Energetics/In Joy OrganicsNew England District OfficeCGMP/Dietary Supplement/Adulterated
02/25/2016VitaSea Products Int'l, dba Wachters Organic Sea ProductsSan Francisco District OfficeUnapproved New Drugs/Misbranded
02/17/2016Lucy's Weight Loss (dba. Waisted With Lucy)Dallas District OfficeUnapproved New Drugs/Misbranded
02/05/2016Beauty & Health International Inc.Los Angeles District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
02/04/2016ABC ProductionsCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016Dose of NatureCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016Green Garden GoldCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016HealthyHempOil.comCenter for Drug Evaluation and ResearchNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016Michigan Herbal RemediesCenter for Drug Evaluation and ResearchNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016Morguetorium, LLCCenter for Drug Evaluation and ResearchNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016PainBombCenter for Drug Evaluation and ResearchNew Drug/Labeling/Misbranded/Cannabidiol
02/04/2016Sana TeCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded/Cannabidiol
02/03/2016ATS Labs, LLCDallas District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
02/02/2016Better Rx, LLCDallas District OfficeUnapproved New Drugs/Misbranded
02/02/2016Calwood Nutritionals, LLCBaltimore District OfficeUnapproved New Drugs/Misbranded
01/20/2016Majopa Industries CorporationSan Juan District OfficeCGMP/Dietary Supplement/Adulterated
01/15/2016Green Supreme Inc.Philadelphia District OfficeNew Drug/Labeling/Misbranded
01/15/2016Nutri-Dyn Midwest, Inc.Minneapolis District OfficeNew Drugs/Dietary Supplements/Labeling/Misbranded/Adulterated
01/13/2016Alkebulan International Services, LLCBaltimore District OfficeCGMP/Dietary Supplement/Adulterated
01/04/2016Tibetan Herbal Balance, Inc.New England District OfficeUnapproved New Drugs/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: 07/26/2016
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