Saturday, December 6, 2014

FDA 2014 Warning Letters involving Unapproved New Drugs/Misbranded

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.  
 
Company NameLetter Issue Date Issuing OfficeSubject
LifeSilver11/19/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Bodyhealth.com, LLC11/18/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Ebola-C Inc11/18/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Avena Botanicals, Inc.11/03/2014New England District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
PI Pharma Inc10/30/2014Cincinnati District OfficeUnapproved New Drugs/Misbranded
Golden Pride, Inc.10/17/2014Florida District OfficeUnapproved New Drugs/Misbranded
Vitamins Direct (USA), Inc.10/17/2014Florida District OfficeUnapproved New Drugs/Misbranded
Vitalab Co Inc10/16/2014Kansas City District OfficeCGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling
Citrus Fit10/15/2014Dallas District OfficeUnapproved New Drugs/Misbranded
Health & Herbs10/15/2014Seattle District OfficeCGMP/Dietary Supplement/Adulterated/Therapeutic Claims
Health Research Laboratories LLC10/09/2014Dallas District OfficeNew Drug/Misbranded
Bethel Nutritional Consulting, Inc10/09/2014New York District OfficeNew Drug/Misbranded
Windmill Health Products, LLC10/07/2014New Jersey District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
YoungYou International Inc10/07/2014Los Angeles District OfficeUnapproved New Drugs/Misbranded
Nova Products, Inc.09/26/2014Philadelphia District OfficeUnapproved New Drugs/Misbranded
Multimmunity, Inc.09/25/2014Denver District OfficeNew Drug/Labeling/Misbranded
Calcomp Nutrition Llc09/24/2014Philadelphia District OfficeUnapproved New Drugs/Misbranded
Natural Solutions Foundation09/23/2014New Jersey District OfficeUnapproved New Drugs/Misbranded
dōTERRA International, LLC09/22/2014Denver District OfficeUnapproved New Drugs/Misbranded
Young Living09/22/2014Denver District OfficeUnapproved New Drugs/Misbranded
West Coast Laboratories Inc09/15/2014Los Angeles District OfficeUnapproved New Drugs/Misbranded
CreAgri, Inc.08/28/2014San Francisco District OfficeNew Drug/Labeling/False & Misleading Claims
GE PHARMA LLC08/26/2014New England District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Descor LLC08/19/2014Baltimore District OfficeUnapproved New Drugs/Misbranded
HUMAN SCIENCE FOUNDATION08/18/2014Los Angeles District OfficeUnapproved Drugs/Misbranded
Plexus Worldwide Inc07/30/2014Los Angeles District OfficeNew Drug/Misbranded
AMS Health Sciences07/25/2014Dallas District OfficeUnapproved New Drugs/Misbranded
Mezotrace Corporation07/25/2014San Francisco District OfficeCGMP/Dietary Supplement/Adulterated
Healthtime dba Deer Garden Foods07/24/2014San Francisco District OfficeNew Drug/Labeling/Misbranded
Schindele Enterprises dba Midwest Wholesale07/17/2014Kansas City District OfficeUnapproved/Misbranded drugs
Klein Laboratories, Inc.07/17/2014New England District OfficeUnapproved New Drug/Adulterated
Noni Connection dba Puna Noni07/14/2014San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Black International Enterprise, LLC dba Puba Store07/10/2014Florida District OfficeUnapproved New Drugs/Misbranded
Dr Benedict S Liao Md07/08/2014Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
Atlantic Trading Co. LLC07/08/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Dr. Bronner's Magic Soaps07/08/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Solace International, Inc.07/03/2014San Francisco District OfficeUnapproved New Drug/Misbranded
Ramon Rosa06/30/2014San Juan District OfficeUnapproved New Drug/Misbranded
Zarbee's, Inc.06/27/2014Denver District OfficeNew Drug/Labeling/Misbranded
Albert Max Inc. dba: Vita Springs Health06/24/2014Los Angeles District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Nutrishop06/05/2014New Jersey District OfficeUnapproved New Drug/Misbranded
Ip-6 International Inc04/23/2014Florida District OfficeUnapproved and Misbranded New Drugs
Mundo Natural Inc04/22/2014San Juan District OfficeUnapproved and Misbranded New Drugs
River Hills Harvest dba Elderberrylife04/22/2014Kansas City District OfficeLabeling/False & Misleading/New Drug/Misbranded
Iowa Select Herbs04/18/2014Kansas City District OfficeNew Drug/Labeling/Misbranded/CGMP/Adulterated
DJ Holding, Inc., DBA Pacific BioLogic Co.04/17/2014San Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Xtra Life Natural Systems, Inc.04/04/2014Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Driven Sports Inc.04/04/2014Center for Food Safety and Applied NutritionDietary Supplement/Adulterated
Graviola Group04/02/2014San Juan District OfficeUnapproved and Misbranded New Drugs
Bio-Recovery Inc.04/01/2014Minneapolis District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
M&A Caribbean Traders, Inc03/28/2014San Juan District OfficeUnapproved and Misbranded New Drugs
Aloe Man International Corp03/21/2014Florida District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Deseo Rebajar03/07/2014San Juan District OfficeUnapproved and Misbranded New Drugs
Exclusive Supplements, Inc.01/31/2014Philadelphia District OfficeUnapproved and Misbranded New Drugs
NatureAll-STF Holding, LLC01/31/2014Denver District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Slim Beauty USA01/31/2014Kansas City District OfficeUnapproved New/Misbranded drugs
Amber Technology, LLC01/30/2014Denver District OfficeNew Animal Drug/Adulterated
Pacific Standard Distributors, Inc01/23/2014Seattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
Intensive Nutrition Incorporated01/22/2014San 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.
quoted from here

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