For Consumers

2014 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 DateCompany NameIssuing OfficeSubject
12/23/2014Shoreside Enterprises Inc.Florida District OfficeUnapproved New Drugs/Misbranded
12/17/2014Dandy Day CorporationDenver District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
12/11/2014Biogenix USA, LLCAtlanta District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
11/24/2014Cell VitalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
11/24/2014Jansen Enterprises, LLC dba HealthWorksUSAMinneapolis District OfficeNew Drug/Labeling/Misbranded
11/19/2014LifeSilverCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
11/21/2014Fioravanti Custom Products DBA Essential Wholesale & LabsSeattle District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
11/18/2014Bodyhealth.com, LLCCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
11/18/2014Ebola-C IncCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
11/14/2014Scientific Botanicals Company, Inc.Seattle District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded/Therapeutic Claims
11/03/2014Avena Botanicals, Inc.New England District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
10/30/2014PI Pharma IncCincinnati District OfficeUnapproved New Drugs/Misbranded
10/17/2014Golden Pride, Inc.Florida District OfficeUnapproved New Drugs/Misbranded
10/17/2014Vitamins Direct (USA), Inc.Florida District OfficeUnapproved New Drugs/Misbranded
10/16/2014Alopecil Corporation, S.R.L.Center for Food Safety and Applied NutritionCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
10/16/2014Vitalab Co IncKansas City District OfficeCGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling
10/15/2014Citrus FitDallas District OfficeUnapproved New Drugs/Misbranded
10/15/2014Health & HerbsSeattle District OfficeCGMP/Dietary Supplement/Adulterated/Therapeutic Claims
10/09/2014Health Research Laboratories LLCDallas District OfficeNew Drug/Misbranded
10/09/2014Bethel Nutritional Consulting, IncNew York District OfficeNew Drug/Misbranded
10/07/2014Windmill Health Products, LLCNew Jersey District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
10/07/2014YoungYou International IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
09/26/2014Nova Products, Inc.Philadelphia District OfficeUnapproved New Drugs/Misbranded
09/25/2014Multimmunity, Inc.Denver District OfficeNew Drug/Labeling/Misbranded
09/24/2014Calcomp Nutrition LlcPhiladelphia District OfficeUnapproved New Drugs/Misbranded
09/23/2014Natural Solutions FoundationNew Jersey District OfficeUnapproved New Drugs/Misbranded
09/22/2014dōTERRA International, LLCDenver District OfficeUnapproved New Drugs/Misbranded
09/22/2014Young LivingDenver District OfficeUnapproved New Drugs/Misbranded
09/15/2014West Coast Laboratories IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
08/28/2014CreAgri, Inc.San Francisco District OfficeNew Drug/Labeling/False & Misleading Claims
08/26/2014GE PHARMA LLCNew England District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
08/19/2014Descor LLCBaltimore District OfficeUnapproved New Drugs/Misbranded
08/18/2014HUMAN SCIENCE FOUNDATIONLos Angeles District OfficeUnapproved Drugs/Misbranded
07/30/2014Plexus Worldwide IncLos Angeles District OfficeNew Drug/Misbranded
07/25/2014AMS Health SciencesDallas District OfficeUnapproved New Drugs/Misbranded
07/25/2014Mezotrace CorporationSan Francisco District OfficeCGMP/Dietary Supplement/Adulterated
07/24/2014Healthtime dba Deer Garden FoodsSan Francisco District OfficeNew Drug/Labeling/Misbranded
07/17/2014Schindele Enterprises dba Midwest WholesaleKansas City District OfficeUnapproved/Misbranded drugs
07/17/2014Klein Laboratories, Inc.New England District OfficeUnapproved New Drug/Adulterated
07/14/2014Noni Connection dba Puna NoniSan Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
07/10/2014Black International Enterprise, LLC dba Puba StoreFlorida District OfficeUnapproved New Drugs/Misbranded
07/08/2014Dr Benedict S Liao MdLos Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
07/08/2014Atlantic Trading Co. LLCCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
07/08/2014Dr. Bronner's Magic SoapsCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
07/03/2014Solace International, Inc.San Francisco District OfficeUnapproved New Drug/Misbranded
06/30/2014Ramon RosaSan Juan District OfficeUnapproved New Drug/Misbranded
06/27/2014Zarbee's, Inc.Denver District OfficeNew Drug/Labeling/Misbranded
06/24/2014Albert Max Inc. dba: Vita Springs HealthLos Angeles District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
06/05/2014NutrishopNew Jersey District OfficeUnapproved New Drug/Misbranded
04/23/2014Ip-6 International IncFlorida District OfficeUnapproved and Misbranded New Drugs
04/22/2014Mundo Natural IncSan Juan District OfficeUnapproved and Misbranded New Drugs
04/22/2014River Hills Harvest dba ElderberrylifeKansas City District OfficeLabeling/False & Misleading/New Drug/Misbranded
04/18/2014Iowa Select HerbsKansas City District OfficeNew Drug/Labeling/Misbranded/CGMP/Adulterated
04/17/2014CDJ Holding, Inc., DBA Pacific BioLogic Co.San Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014Xtra Life Natural Systems, Inc.Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014Driven Sports Inc.Center for Food Safety and Applied NutritionDietary Supplement/Adulterated
04/02/2014Graviola GroupSan Juan District OfficeUnapproved and Misbranded New Drugs
04/01/2014Bio-Recovery Inc.Minneapolis District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
03/28/2014M&A Caribbean Traders, IncSan Juan District OfficeUnapproved and Misbranded New Drugs
03/21/2014Aloe Man International CorpFlorida District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
03/07/2014Deseo RebajarSan Juan District OfficeUnapproved and Misbranded New Drugs
01/31/2014Exclusive Supplements, Inc.Philadelphia District OfficeUnapproved and Misbranded New Drugs
01/31/2014NatureAll-STF Holding, LLCDenver District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
01/31/2014Slim Beauty USAKansas City District OfficeUnapproved New/Misbranded drugs
01/30/2014Amber Technology, LLCDenver District OfficeNew Animal Drug/Adulterated
01/23/2014Pacific Standard Distributors, IncSeattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
01/22/2014Intensive Nutrition IncorporatedSan Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
*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: 02/24/2015
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