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
10/19/2016Colabs Intl CorpSan Francisco District OfficeUnapproved New Drugs/Misbranded
10/19/2016Diamond Wipes International, Inc.Los Angeles District OfficeUnapproved New Drugs/Misbranded
10/18/2016SCS Direct, Inc.New England District OfficeUnapproved New Drugs/Misbranded
10/18/2016PhytoCeuticals, Inc.New Jersey District OfficeUnapproved New Drugs/Misbranded
10/12/2016Threshold Enterprises LtdSan Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
10/12/2016Vetix Inc.Cincinnati District OfficeUnapproved New Animal Drug/Adultered/Misbranded/Misleading
10/07/2016Buck Mountain Herbs Botanicals, Inc.Kansas City District OfficeUnapproved New Animal Drug/Adulterated
09/27/2016Proprietary Wellness LLCCincinnati District OfficeDietary Supplement/Misbranded
09/27/2016Osea InternacionalCenter for Food Safety and Applied NutritionNew Drug/Labeling/False & Misleading Claims
09/20/2016Face NaturalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/False & Misleading Claims
09/15/2016D&K FoodsCenter for Food Safety and Applied NutritionNew Drug/Misbranded
09/15/2016Desert FarmsLos Angeles District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
09/15/2016Positive Power NutritionLos Angeles District OfficeNew Drug/Misbranded
09/02/2016Harrington House LtdCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
09/01/2016Enessa Inc Los Angeles District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims
08/31/2016Bio-Stasis International, Inc.Los Angeles District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
08/29/2016Zo Skin Health Inc.Los Angeles District OfficeNew Drug/Labeling/Misbranded
08/26/2016Healing Noni Co., LLCSan Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
08/18/2016Sarkli Repechage LtdNew Jersey District OfficeNew Drug/Labeling/Misbranded
08/12/2016Cape Apothecary, Inc.Baltimore District OfficeUnapproved New Drug/Compounding/Misbranding/Adulterated
08/01/2016Tata Harper SkincareNew England District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
07/29/2016NuVet LabsLos Angeles District OfficeNew Animal Drug/Adulterated
07/29/2016Healing ScentsChicago District OfficeNew Drug/Labeling/Misbranded
07/28/2016Min NyNew York District OfficeNew Drug/Labeling/Misbranded
07/22/2016Celloxess LLCNew Jersey District OfficeNew Drug/Misbranded
07/22/2016J&E International CorpSeattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
07/22/2016Hsu's Ginseng Enterprises, IncMinneapolis District OfficeNew Drug/Labeling/Misbranded
07/22/2016New Horizon Nutraceuticals LLCPhiladelphia District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
07/21/2016La Bella FiguraChicago District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
07/20/2016Finally Pure, LLCSeattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
07/19/2016Sheryl GibbsPhiladelphia District OfficeNew Drug/Labeling/False & Misleading Claims
07/19/2016Sircuit SkinLos Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
07/18/2016Menscience AndroceuticalsFlorida District OfficeNew Drug/Labeling/Misbranded
07/18/2016Michael ToddFlorida District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
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
06/20/2016Vitalife Inc.Los Angeles District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
06/16/2016Centro NaturistaDallas District OfficeUnapproved New Drugs/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
04/08/2016Salud Natural Entrepreneurs, Inc.Chicago 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: 11/01/2016
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