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