For Consumers

2012 Warning Letters - Health Fraud

Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations.

For allFDA WarningLetters, click here

Letter Issue Date Company Name Issuing Office Subject
12/21/2012 ForMor, Inc. d/b/a ForMor International Dallas District Office CGMP/Dietary Supplements/Adulterated
12/11/2012 Amarc Enterprises Los Angeles District Office New Animal Drug/Adulterated
12/04/2012 USPlabs, LLC Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
11/19/2012 Emu Products and Management, Inc. (EPMI) Dallas District Office New Drug/Misbranded
11/05/2012 Women's Health Institute of Texas Dallas District Office New Drug/Misbranded
11/05/2012 The Avalon Effect Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
11/02/2012 Atrium Inc. Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
10/23/2012 Hail Merry, LLC Dallas District Office Food Labeling/False & Misleading/Misbranded
10/22/2012 Health Breakthroughs International, LLC Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs
10/18/2012 Mushroom Wisdom New Jersey District Office Unapproved and Misbranded New Drugs
10/16/2012 Advanced Nutritional Technology Inc San Francisco District Office CGMP/Dietary Supplement/Misbranding
10/16/2012 Quincy Bioscience Manufacturing Minneapolis District Office Unapproved and Misbranded New Drugs
10/15/2012 Bioneurix Los Angeles District Office Dietary Supplement/Labeling/Misbranded
10/15/2012 Ortho Molecular Products Inc Minneapolis District Office New Drug/Labeling/Misbranded
10/10/2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded
10/05/2012 Food for Health International, LLC Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated
10/02/2012 AHN International Inc DBA Amazing Herbs Nutraceuticals Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
09/28/2012 Healthy People Co Los Angeles District Office Unapproved and Misbranded New Drugs
09/21/2012 Andes Natural Center for Food Safety and Applied Nutrition New Drug Application [NDA]
09/18/2012 Canadadrugs Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
09/18/2012 Arkadiy Kisin/White Forest Solutions Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
09/18/2012 Eyal Bar Oz Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
09/18/2012 EyeScience Labs, L.L.C. Cincinnati District Office Promotional Claims False & Misleading/New Drugs
09/10/2012 Global Source Management & Consulting Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded
08/28/2012 Regeneca, Inc. Los Angeles District Office Dietary Supplement/Adulterated
08/28/2012 Trinity Sports Group, Inc. Dallas District Office New Drug/Labeling/Misbranded
08/27/2012 Naturavit, Inc. Florida District Office CGMP for Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded
08/27/2012 PruTect Rx New Orleans District Office New Drug/Labeling/Misbranded
08/23/2012 Mark's Marine Pharmacy Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
08/15/2012 Healing Ways Los Angeles District Office New Drug/Labeling/False & Misleading Claims
08/15/2012 Dragon Herbs Los Angeles District Office New Drug/Labeling/False & Misleading Claims
08/02/2012 HSAC Enterprises, Inc. dba Kare-N-Herbs New England District Office Drug/Labeling/False & Misleading Claims
08/01/2012 Bio Health Solutions Florida District Office Labeling/False & Misleading Claims/Misbranded
07/30/2012 Grato, Inc. Kansas City District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded
07/20/2012 Lithia Mineral Water, Inc. Atlanta District Office Dietary Supplement/Adulterated
07/10/2012 Evol Nutrition Associates, Inc. Atlanta District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded
06/28/2012 Prismic Light International New Orleans District Office CGMP for Dietary Supplements/Adulterated/Misbranded
06/26/2012 Alistrol Health Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded
06/19/2012 ABCO Laboratories, Inc. San Francisco District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
06/12/2012 Set-N-Me-Free Aloe Vera Co. Seattle District Office New Drug/Labeling/False & Misleading Claims/Misbranded
06/08/2012 Michelle's Miracle, Inc. Detroit District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
06/07/2012 Oza Compound Products, LLC Detroit District Office CGMP for Dietary Supplement/Adulterated/Misbranded
05/24/2012 Best Price Rx Center for Drug Evaluation and Research Unapproved/Misbranded New Drug
05/24/2012 Northwest Pharmacy Center for Drug Evaluation and Research Unapproved New Drug-Misbranded
05/24/2012 Good Herbs, Inc. Detroit District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/23/2012 Himalayan Int'l Inst. of Yoga Science and Phil. of the USA Philadelphia District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/14/2012 Caribe Natural LLC Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/08/2012 Reaction Nutrition Philadelphia District Office CGMP for Dietary Supplements/Adulterated/Misbranded
05/07/2012 Quadex Pharmaceuticals Denver District Office OTC Drug Labeling/New Drug/Misbranded
04/24/2012 Vitality Distributing Cincinnati District Office Unapproved New Drugs/Misbranded
04/19/2012 Nature's Pearl Corporation Atlanta District Office Unapproved New Drugs/Misbranded Dietary Supplements
04/18/2012 From Fatigued to Fantastic, LLC Baltimore District Office Unapproved New Drug Promotional Claims/Misbranded
04/17/2012 Naprodis, Inc. Los Angeles District Office Labeling/New Drug/Misbranded
04/12/2012 Healing with Essaic Tea Florida District Office False & Misleading Claims/New Drug
04/04/2012 Leaner Living Baltimore District Office Unapproved New Drug Promotional Claims/Misbranded
03/22/2012 High Performance Formulas, L.L.C. (HPF, L.L.C) Philadelphia District Office New Drug/Labeling/Misbranded
03/05/2012 Breathable Foods, Inc. New England District Office

False & Misleading Claims/Misbranded

02/15/2012 Schwabe North America, Inc. Minneapolis District Office Unapproved New Drug/Misbranded
02/09/2012 BioAnue Laboratories, Inc. Atlanta District Office Dietary Supplement/New Drug
02/06/2012 Globe All Wellness, LLC Florida District Office New Drugs/Dietary Supplements/Misbranded
01/19/2012 Mushroom Wisdom New Jersey District Office False & Misleading Claims/New Drug
01/18/2012 Formulife, Inc. Purus Labs, Inc. d.b.a. Dark Cyde Supplements Dallas District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded
01/10/2012 Agora Publishing Baltimore District Office New Drug/Labeling/Misbranded
01/18/2012 Almased USA, Inc. Florida District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded
01/06/2012 Royal Domains Atlanta District Office Unapproved New Drugs/Misbranded Dietary Supplements

*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: 09/04/2015
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