For Consumers

2013 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
Illegally Sold Diabetes Treatments Initiative - 15 letters
12/31/2013 Prestige Chinese Teas Company, Inc. San Francisco District Office CGMP/Manufacturing/Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
12/26/2013 NVN Therapeutics Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded
12/26/2013 Accera, Inc. Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded
12/20/2013 Star Scientific, Inc. Center for Food Safety and Applied Nutrition Unapproved and Misbranded New Drugs, Anatabloc and CigRx
12/09/2013 Mayor Laboratories Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded
12/05/2013 Green Planet Los Angeles District Office Unapproved and Misbranded New Drugs
10/11/2013 USP Labs, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
09/25/2013 Standard Homeopathic Company Inc. Los Angeles District Office False & Misleading Claims/Misbranded
09/19/2013 Dolgencorp Inc New Orleans District Office Labeling/False & Misleading Claims/Misbranded
09/19/2013 Homeolab Inc. Center for Drug Evaluation and Research Labeling/False & Misleading Claims/Misbranded
09/19/2013 Insight Pharmaceuticals Corporation Philadelphia District Office Labeling/False & Misleading Claims/Misbranded
09/19/2013 Medtech Products, Inc. New York District Office Labeling/False & Misleading Claims/Misbranded
09/19/2013 Topco Assoc Chicago District Office Labeling/False & Misleading Claims/Misbranded
09/09/2013 Brower Enterprises Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
09/06/2013 Pure Energy Products Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
08/29/2013 Y.S. Health Corp Chicago District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Unapproved/Misbranded
08/22/2013 GumRunner, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims
08/21/2013 Dolphin Intertrade Corporation Florida District Office Unapproved and Misbranded New Drugs
08/13/2013 Metagenics Seattle District Office Medical Foods and New Drug/Labeling/Internet Claims/Misbranded
08/12/2013 Herbal Papaya Dallas District Office New Drug/Labeling/Misbranded
08/07/2013 Vibrant Life Los Angeles District Office New Drug/Labeling/Misbranded
08/01/2013 Lumina Health Products, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
07/23/2013 Natural Products Services, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
07/19/2013 ProNatural Nutrition Denver District Office CGMP for Dietary Supplements/Adulterated
06/26/2013 EvaPharmacy Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs
06/25/2013 Nutrient Synergy, Inc Denver District Office New Drug/Labeling/Misbranded
06/24/2013 North Dallas Honey Dallas District Office Labeling/New Drug/Misbranded
06/18/2013 Herbs of Light, Inc. Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded
06/17/2013 Formulife, Inc. Dallas District Office Unapproved New Drug/Adulterated/Misbranded
05/29/2013 Bio-Botanica, Inc. New York District Office New Drug/Misbranded
05/24/2013 Sundial Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/24/2013 Crop Pharms New York District Office Unapproved and Misbranded New Drugs
05/21/2013 Teeter Creek Herbs, Inc. Kansas City District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded
05/14/2013 Zi Xiu Tang Success, LLC Philadelphia District Office Unapproved and Misbranded New Drugs
05/08/2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs
05/02/2013 American Natural Products Inc Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/02/2013 Earthborn Products, Inc. Los Angeles District Office New Drug/Labeling/Misbranded
05/02/2013 Alternative Health Supplements Detroit District Office Unapproved and Misbranded New Drugs
04/24/2013 Glucorell Inc./Anafit, Inc. Florida District Office Unapproved and Misbranded New Drugs
04/24/2013 Europharma Co., Inc. Minneapolis District Office New Drug/Labeling/False & Misleading Claims
04/11/2013 Realm Labs, LLC Florida District Office Unapproved and Misbranded New Drugs
04/08/2013 Body Systems Inc Florida District Office Unapproved and Misbranded New Drugs
04/05/2013 The Glutathione Corporation New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/02/2013 Natures Health Options LLC Florida District Office Unapproved and Misbranded New Drugs
04/02/2013 Juve International, LLC Denver District Office New Drug/Labeling/False & Misleading Claims
03/20/2013 Birkdale Medicinals LLC Detroit District Office Unapproved and Misbranded New Drugs
03/19/2013 Sunset Natural Products Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
03/15/2013 Synticare Corp Los Angeles District Office New Drug/Labeling/False & Misleading Claims
03/13/2013 Coral Rock Man, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
03/12/2013 Natural Medicine Associates, Inc Florida District Office Unapproved and Misbranded New Drugs
03/08/2013 Algaen Corporation Atlanta District Office Unapproved New Drug/Adulterated/Misbranded
02/25/2013 Altasource LLC DBA Metalabs LLC Atlanta District Office Unapproved and Misbranded New Drugs
02/14/2013 Laclede Inc Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
02/11/2013 Kreativ Health Inc Dba Natural Food Supplements Los Angeles District Office CGMP/Manufacturing/Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
02/11/2013 Kosher Vitamin Express Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Discount Online Pharmacy Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Medsnoscript Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Oasis Consumer Healthcare, LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Sun Drug Store Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Supplementality LLC Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Secure Medical Inc Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/11/2013 Vitalmax Vitamins Center for Food Safety and Applied Nutrition Unapproved Products Related to the 2012/2013 Flu Season
02/07/2013 University of Berkley Center for Biologics Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season
02/04/2013 Big Mountain Drugs Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
02/04/2013 buy-pharma.com Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
01/31/2013 Liquid Health, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
01/29/2013 M.D.R. Fitness Corp Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
01/24/2013 Flu & Cold Defense LLC Center for Drug Evaluation and Research Unapproved Products Related to the 2012/2013 Flu Season

*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
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English