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2014 Warning Letters - Health Fraud

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 Date Company Name Issuing Office Subject
12/23/2014 Shoreside Enterprises Inc. Florida District Office Unapproved New Drugs/Misbranded
12/17/2014 Dandy Day Corporation Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
12/11/2014 Biogenix USA, LLC Atlanta District Office CGMP/Dietary Supplement/Adulterated/Misbranded
11/24/2014 Cell Vitals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
11/24/2014 Jansen Enterprises, LLC dba HealthWorksUSA Minneapolis District Office New Drug/Labeling/Misbranded
11/19/2014 LifeSilver Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
11/21/2014 Fioravanti Custom Products DBA Essential Wholesale & Labs Seattle District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims
11/18/2014 Bodyhealth.com, LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
11/18/2014 Ebola-C Inc Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
11/14/2014 Scientific Botanicals Company, Inc. Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded/Therapeutic Claims
11/03/2014 Avena Botanicals, Inc. New England District Office CGMP/Dietary Supplement/Adulterated/Misbranded
10/30/2014 PI Pharma Inc Cincinnati District Office Unapproved New Drugs/Misbranded
10/17/2014 Golden Pride, Inc. Florida District Office Unapproved New Drugs/Misbranded
10/17/2014 Vitamins Direct (USA), Inc. Florida District Office Unapproved New Drugs/Misbranded
10/16/2014 Alopecil Corporation, S.R.L. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
10/16/2014 Vitalab Co Inc Kansas City District Office CGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling
10/15/2014 Citrus Fit Dallas District Office Unapproved New Drugs/Misbranded
10/15/2014 Health & Herbs Seattle District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims
10/09/2014 Health Research Laboratories LLC Dallas District Office New Drug/Misbranded
10/09/2014 Bethel Nutritional Consulting, Inc New York District Office New Drug/Misbranded
10/07/2014 Windmill Health Products, LLC New Jersey District Office CGMP/Dietary Supplement/Adulterated/Misbranded
10/07/2014 YoungYou International Inc Los Angeles District Office Unapproved New Drugs/Misbranded
09/26/2014 Nova Products, Inc. Philadelphia District Office Unapproved New Drugs/Misbranded
09/25/2014 Multimmunity, Inc. Denver District Office New Drug/Labeling/Misbranded
09/24/2014 Calcomp Nutrition Llc Philadelphia District Office Unapproved New Drugs/Misbranded
09/23/2014 Natural Solutions Foundation New Jersey District Office Unapproved New Drugs/Misbranded
09/22/2014 dōTERRA International, LLC Denver District Office Unapproved New Drugs/Misbranded
09/22/2014 Young Living Denver District Office Unapproved New Drugs/Misbranded
09/15/2014 West Coast Laboratories Inc Los Angeles District Office Unapproved New Drugs/Misbranded
08/28/2014 CreAgri, Inc. San Francisco District Office New Drug/Labeling/False & Misleading Claims
08/26/2014 GE PHARMA LLC New England District Office CGMP/Dietary Supplement/Adulterated/Misbranded
08/19/2014 Descor LLC Baltimore District Office Unapproved New Drugs/Misbranded
08/18/2014 HUMAN SCIENCE FOUNDATION Los Angeles District Office Unapproved Drugs/Misbranded
07/30/2014 Plexus Worldwide Inc Los Angeles District Office New Drug/Misbranded
07/25/2014 AMS Health Sciences Dallas District Office Unapproved New Drugs/Misbranded
07/25/2014 Mezotrace Corporation San Francisco District Office CGMP/Dietary Supplement/Adulterated
07/24/2014 Healthtime dba Deer Garden Foods San Francisco District Office New Drug/Labeling/Misbranded
07/17/2014 Schindele Enterprises dba Midwest Wholesale Kansas City District Office Unapproved/Misbranded drugs
07/17/2014 Klein Laboratories, Inc. New England District Office Unapproved New Drug/Adulterated
07/14/2014 Noni Connection dba Puna Noni San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded
07/10/2014 Black International Enterprise, LLC dba Puba Store Florida District Office Unapproved New Drugs/Misbranded
07/08/2014 Dr Benedict S Liao Md Los Angeles District Office New Drug/Labeling/False & Misleading Claims
07/08/2014 Atlantic Trading Co. LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
07/08/2014 Dr. Bronner's Magic Soaps Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded
07/03/2014 Solace International, Inc. San Francisco District Office Unapproved New Drug/Misbranded
06/30/2014 Ramon Rosa San Juan District Office Unapproved New Drug/Misbranded
06/27/2014 Zarbee's, Inc. Denver District Office New Drug/Labeling/Misbranded
06/24/2014 Albert Max Inc. dba: Vita Springs Health Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
06/05/2014 Nutrishop New Jersey District Office Unapproved New Drug/Misbranded
04/23/2014 Ip-6 International Inc Florida District Office Unapproved and Misbranded New Drugs
04/22/2014 Mundo Natural Inc San Juan District Office Unapproved and Misbranded New Drugs
04/22/2014 River Hills Harvest dba Elderberrylife Kansas City District Office Labeling/False & Misleading/New Drug/Misbranded
04/18/2014 Iowa Select Herbs Kansas City District Office New Drug/Labeling/Misbranded/CGMP/Adulterated
04/17/2014 CDJ Holding, Inc., DBA Pacific BioLogic Co. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014 Xtra Life Natural Systems, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/04/2014 Driven Sports Inc. Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/02/2014 Graviola Group San Juan District Office Unapproved and Misbranded New Drugs
04/01/2014 Bio-Recovery Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded
03/28/2014 M&A Caribbean Traders, Inc San Juan District Office Unapproved and Misbranded New Drugs
03/21/2014 Aloe Man International Corp Florida District Office CGMP/Dietary Supplement/Adulterated/Misbranded
03/07/2014 Deseo Rebajar San Juan District Office Unapproved and Misbranded New Drugs
01/31/2014 Exclusive Supplements, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs
01/31/2014 NatureAll-STF Holding, LLC Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
01/31/2014 Slim Beauty USA Kansas City District Office Unapproved New/Misbranded drugs
01/30/2014 Amber Technology, LLC Denver District Office New Animal Drug/Adulterated
01/23/2014 Pacific Standard Distributors, Inc Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs
01/22/2014 Intensive Nutrition Incorporated San Francisco District Office CGMP/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.