For Consumers

2011 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
Homeopathic HCG Weight Loss Initiative - 6 Letters
Sexually Transmitted Disease Fraud Initiative - 12 letters
Natural Health Team 12/28/2011 New Orleans District Office Unapproved NewDrug
The hCG Drops, LLC 12/21/2011 Denver District Office Homeopathic HCG Initiative
Nenningers Naturals, LLC 12/14/2011 New York District Office False & Misleading Claims/New Drug/Misbranded
Atlantic Pro Nutrients, Inc. dba XYMOGEN 12/13/2011 Florida District Office CGMP/Manufacturing/Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Quasar Bio-Tech, Inc. dba Silver Bay LLC 12/09/2011 Florida District Office Premarket Approval/Misbranded/Adulterated
Revolt Distribution 12/08/2011 Atlanta District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
Med-Chem Labs 12/06/2011 Detroit District Office Promotional Claims False & Misleading/New Drugs
DreamLife, LLC 12/01/2011 New Orleans District Office CGMP/Dietary Supplement/Adulterated
Nutri Fusion Systems, Inc 11/28/2011 Denver District Office Homeopathic HCG Initiative
Natural Medical Supply, LLC DBA HCG Complete Diet 11/28/2011 Denver District Office Homeopathic HCG Initiative
HCG Platinum, LLC 11/28/2011 Denver District Office Homeopathic HCG Initiative
Theoriginalhcgdrops.com 11/28/2011 New York District Office Homeopathic HCG Initiative
HCG Diet Direct, LLC 11/28/2011 Los Angeles District Office HomeopathicHCG Initiative
Hcg-miracleweightloss.com 11/28/2011 Seattle District Office Homeopathic HCG Initiative
Hill's Pet Nutrition Inc 11/23/2011 Kansas City District Office Labeling/Unapproved New Animal Drug/Adulterated
CocoKefir LLC 11/22/2011 Minneapolis District Office PromotionalClaims False & Misleading/New Drugs
NanoLiposomal Nutritionals 11/22/2011 Los Angeles District Office Unapproved Drugs/Misbranded
WellnessOne World, LLC 11/16/2011 Minneapolis District Office CGMP/Manufacturing,Packaging, Labeling, or Holding Operations for Dietary Suppements/Adulterated
Golden Temple of Oregon, LLC 11/10/2011 Seattle District Office CGMP for Dietary Supplements/New Drug Claims
Precision Formulations, LP 10/24/2011 Dallas District Office CGMP for Dietary Supplements/Adulterated
Jenahexal Pharm GmbH 10/19/2011 Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Unapproved NewDrugs
Nordimex, LLC 10/11/2011 Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Galyna/Ivan Podornikova 09/21/2011 Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
SPHERE Inc. 09/21/2011 Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs
Nature's Rite 09/19/2011 Denver Distict Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded
Algonot, LLC 09/16/2011 Florida District Office New Drug/Misbranded
Dr Foster's Essentials 09/09/2011 Los Angeles District Office Labeling/False & Misleading Claims/Misbranded
Chronicity 09/07/2011 Dallas District Office Labeling/False & Misleading Claims/New Drug/Misbranded
Pharmacist's Ultimate Health Corp. 08/22/2011 Minneapolis District Office Labeling Claims
Brazilian Blowout 08/22/2011 Center for Food Safety and Applied Nutrition Cosmetics/Adulterated/Misbranded
For Earth, Inc. 08/19/2011 Florida District Office New Drug/Labeling/False & Misleading Claims
Creation's Garden Natural Products, Inc. 08/04/2011 LosAngeles District Office New Drug/Misbranded
Grand Cakes Inc. 07/15/2011 San Juan District Office Food Labeling/Adulterated/Misbranded
Natural Guidance, LLC 07/15/2011 Florida District Office Labeling/False & Misleading Claims/New Drug/Misbranded
Hardy Peanuts, Inc. 07/15/2011 Atlanta District Office New Drug/Misbranded
Shaping Beauty Inc./H & S GMP Factory 07/17/2011 Philadelphia District Office Unapproved New Drug/Misbranded
Confidence Inc. 07/07/2011 New York District Office CGMP/Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulation/Adulterated
Premium Gold Flax Products & Processing Inc. 07/07/2011 Minneapolis District Office Unapproved New Drug/Misbranded
Matrixx Initiatives Inc 06/03/2011 Los Angeles District Office New Drug/Misbranded
Tatra Herb Company 06/01/2011 Philadelphia District Office New Drug/Labeling/Misbranded
Ethos Environmental Inc dba Regeneca International Inc 05/25/2011 Los Angeles District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
Cellular Rx 05/25/2011 Kansas City District Office New Drug/Misbranded
Union Springs Pharmaceuticals, LLC 05/23/2011 Center for Drug Evaluation and Research Internet Unapproved Drug/Misbranded
Ten Ren Tea Company of San Francisco, Ltd 05/06/2011 San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded
Ten Tea 05/06/2011 San Francisco District Office New Drug/Unauthorized Health Claims/Misbranded
Le Natural, Inc. 05/02/2011 SanJuan District Office Labeling Drug Claims
Polydna 04/28/2011 New York District Office

Drug Products/Therapeutic Claims

Chlamydia-clinic.com 04/28/2011 San Francisco District Office

Drug Products/Therapeutic Claims

Everclr3 04/28/2011 Seattle District Office Drug Products/Therapeutic Claims
Premier Micronutrient Corporation 04/28/2011 New Orleans District Office Labeling Drug Claims
Derma Remedies 04/28/2011 Center for Drug Evaluation and Research New Drug/Misbranded
Viruxo.com 04/28/2011 Center for Food Safety and Applied Nutrition New Drug/Misbranded
Flor Nutraceuticals, LLC 04/28/2011 Dallas District Office New Drug/Misbranded
Immuneglory.com 04/28/2011 San Francisco District Office New Drug/Misbranded
Medavir Medical Advances, Inc. 04/28/2011 Florida District Office New Drug/Misbranded
Pacific Naturals 04/28/2011 Los Angeles District Office New Drug/Misbranded
Master Peace Inc 04/28/2011 Cincinnati District Office Drug Products/Therapeutic Claims
International Institute of Holistic Healing, Inc. 04/28/2011 Dallas District Office Drug Products/Therapeutic Claims
LesaSverid 04/28/2011 New England District Office Drug Products/Therapeutic Claims
Natural Path/Silver Wings, LLC 04/28/2011 New Orleans District Office cGMP/Unapproved New Drug/Dietary Supplement/Adulterated/Misbranded
Diaspora Tea & Herbdba Rishi Tea 04/28/2011 Minneapolis District Office New Drugs/Unauthorized Nutrient Content
Intelli Health 04/27/2011 Florida District Office Promotional Claims/New Drug/Misbranded
Tec Laboratories Inc 04/18/2011 Seattle District Office New Drug/Misbranded
Oh So Clean, Inc. 04/18/2011 San Francisco District Office New Drug/Misbranded
Dr G H Tichenor Antiseptic Company 04/18/2011 New Orleans District Office New Drug/Misbranded
JD Nelson and Associates, LLC 04/18/2011 Cincinnati District Office Unapproved New Drug
Lifetech Resources 04/18/2011 Los Angeles District Office Promotional Claims/New Drug/Misbranded
Eidon, Inc 04/08/2011 Los Angeles District Office Unapproved New Drug Promotional Claims/Misbranded
KT Botanicals 04/07/2011 San Francisco District Office New Drug/Misbranded
Meditherm Inc. 04/04/2011 Center for Devices and Radiological Health False & Misleading Claims/Misbranded
Omega Nutrition U.S.A., Inc. 04/06/2011 Seattle District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded
Saw Palmetto 03/28/2011 Florida District Office New Drug/Misbranded
AloeElite 03/28/2011 Florida District Office New Drug/Misbranded
Three Rivers Pharmaceuticals 03/21/2011 New England District Office Labeling/New Drug/Misbranded
Gaspari Nutrition, Inc. 03/02/2011 New Jersey District Office

cGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

Jaba Labs 03/01/2011 Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded
Lifeway Foods, Inc. 02/18/2011 Chicago District Office New Drug/Misbranded
Nutrasilver.com 02/18/2011 San Francisco District Office New Drug/Labeling/Misbranded
Millennium Bioceutics 02/17/2011 Center for Food Safety and Applied Nutrition New Drugs/Dietary Supplements/Food Labeling/Misbranded
RHG & Company Inc., dba Vital Nutrients 02/16/2011 NewEngland DistrictOffice Dietary Supplement/Adulterated
Abba Pharma Inc. 02/09/2011 Florida District Office Dietary Supplement/Adulterated
Ancient Formulas Inc. 02/09/2011 Kansas City District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
Limpia Arteria 02/04/2011 Center for Food Safety and Applied Nutrition Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Tennessee Scientific, Inc./Scientific Formulations LLC 02/01/2011 New Orleans District Office New Drug/Adulterated/Misbranded
Upsher Smith Laboratories, Inc. 01/19/2011 Minneapolis District Office Labeling Drug Claims

*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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