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U.S. Department of Health and Human Services

For Consumers

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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 NameLetter Issue Date Issuing OfficeSubject
CreAgri, Inc.08/28/2014San Francisco District OfficeNew Drug/Labeling/False & Misleading Claims
HUMAN SCIENCE FOUNDATION08/18/2014Los Angeles District OfficeUnapproved Drugs/Misbranded
Plexus Worldwide Inc07/30/2014Los Angeles District OfficeNew Drug/Misbranded
Mezotrace Corporation07/25/2014San Francisco District OfficeCGMP/Dietary Supplement/Adulterated
Healthtime dba Deer Garden Foods07/24/2014San Francisco District OfficeNew Drug/Labeling/Misbranded
Schindele Enterprises dba Midwest Wholesale07/17/2014Kansas City District OfficeUnapproved/Misbranded drugs
Klein Laboratories, Inc.07/17/2014New England District OfficeUnapproved New Drug/Adulterated
Noni Connection dba Puna Noni07/14/2014San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Black International Enterprise, LLC dba Puba Store07/10/2014Florida District OfficeUnapproved New Drugs/Misbranded
Atlantic Trading Co. LLC07/08/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Dr. Bronner's Magic Soaps07/08/2014Center for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
Solace International, Inc.07/03/2014San Francisco District OfficeUnapproved New Drug/Misbranded
Ramon Rosa06/30/2014San Juan District OfficeUnapproved New Drug/Misbranded
Zarbee's, Inc.06/27/2014Denver District OfficeNew Drug/Labeling/Misbranded
Albert Max Inc. dba: Vita Springs Health06/24/2014Los Angeles District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Nutrishop06/05/2014New Jersey District OfficeUnapproved New Drug/Misbranded
Ip-6 International Inc04/23/2014Florida District OfficeUnapproved and Misbranded New Drugs
Mundo Natural Inc04/22/2014San Juan District OfficeUnapproved and Misbranded New Drugs
River Hills Harvest dba Elderberrylife04/22/2014Kansas City District OfficeLabeling/False & Misleading/New Drug/Misbranded
Iowa Select Herbs04/18/2014Kansas City District OfficeNew Drug/Labeling/Misbranded/CGMP/Adulterated
DJ Holding, Inc., DBA Pacific BioLogic Co.04/17/2014San Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Xtra Life Natural Systems, Inc.04/04/2014Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Driven Sports Inc.04/04/2014Center for Food Safety and Applied NutritionDietary Supplement/Adulterated
Graviola Group04/02/2014San Juan District OfficeUnapproved and Misbranded New Drugs
Bio-Recovery Inc.04/01/2014Minneapolis District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
M&A Caribbean Traders, Inc03/28/2014San Juan District Officepproved and Misbranded New Drugs
Aloe Man International Corp03/21/2014Florida District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Deseo Rebajar03/07/2014San Juan District OfficeUnapproved and Misbranded New Drugs
Exclusive Supplements, Inc.01/31/2014Philadelphia District OfficeUnapproved and Misbranded New Drugs
NatureAll-STF Holding, LLC01/31/2014Denver District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Slim Beauty USA01/31/2014Kansas City District OfficeUnapproved New/Misbranded drugs
Amber Technology, LLC01/30/2014Denver District OfficeNew Animal Drug/Adulterated
Pacific Standard Distributors, Inc01/23/2014Seattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
Intensive Nutrition Incorporated01/22/2014San Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
  
 
Company NameLetter Issue Date Issuing OfficeSubject
Illegally Sold Diabetes Treatments Initiative - 15 letters 
Prestige Chinese Teas Company, Inc.12/31/2013San Francisco District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
NVN Therapeutics12/26/2013Center for Food Safety and Applied NutritionMedical Foods/Unapproved New Drug/Misbranded
Accera, Inc.12/26/2013Center for Food Safety and Applied NutritionMedical Foods/Unapproved New Drug/Misbranded
Star Scientific, Inc.12/20/2013Center for Food Safety and Applied NutritionUnapproved and Misbranded New Drugs, Anatabloc and CigRx
Mayor Laboratories Inc12/09/2013Los Angeles District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
Green Planet12/05/2013Los Angeles District OfficeUnapproved and Misbranded New Drugs
USP Labs, LLC 10/11/2013Center for Food Safety and Applied NutritionDietary Supplement/Adulterated
Standard Homeopathic Company Inc. 09/25/2013Los Angeles District OfficeFalse & Misleading Claims/Misbranded
Dolgencorp Inc 09/19/2013New Orleans District OfficeLabeling/False & Misleading Claims/Misbranded
Homeolab Inc. 09/19/2013Center for Drug Evaluation and ResearchLabeling/False & Misleading Claims/Misbranded
Insight Pharmaceuticals Corporation 09/19/2013Philadelphia District OfficeLabeling/False & Misleading Claims/Misbranded
Medtech Products, Inc. 09/19/2013New York District OfficeLabeling/False & Misleading Claims/Misbranded
Topco Assoc 09/19/2013Chicago District OfficeLabeling/False & Misleading Claims/Misbranded
Brower Enterprises 09/09/2013Minneapolis District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Pure Energy Products 09/06/2013Dallas District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Y.S. Health Corp 08/29/2013Chicago District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Unapproved/Misbranded
GumRunner, LLC 08/22/2013Center for Food Safety and Applied NutritionNew Drug/Labeling/False & Misleading Claims
Dolphin Intertrade Corporation 08/21/2013Florida District OfficeUnapproved and Misbranded New Drugs
Metagenics 08/13/2013Seattle District OfficeMedical Foods and New Drug/Labeling/Internet Claims/Misbranded
Herbal Papaya 08/12/2013Dallas District OfficeNew Drug/Labeling/Misbranded
Vibrant Life 08/07/2013Los Angeles District OfficeNew Drug/Labeling/Misbranded
Lumina Health Products, Inc. 08/01/2013Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Natural Products Services, Inc. 07/23/2013Los Angeles District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
ProNatural Nutrition 07/19/2013Denver District OfficeCGMP for Dietary Supplements/Adulterated
EvaPharmacy 06/26/2013Center for Drug Evaluation and ResearchInternet Marketing of Unapproved and Misbranded Drugs
Nutrient Synergy, Inc 06/25/2013Denver District OfficeNew Drug/Labeling/Misbranded
North Dallas Honey 06/24/2013Dallas District OfficeLabeling/New Drug/Misbranded
Herbs of Light, Inc. 06/18/2013Florida District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
Formulife, Inc. 06/17/2013Dallas District OfficeUnapproved New Drug/Adulterated/Misbranded
Bio-Botanica, Inc. 05/29/2013New York District OfficeNew Drug/Misbranded
Sundial Herbal Products 05/24/2013New York District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Crop Pharms 05/24/2013New York District OfficeUnapproved and Misbranded New Drugs
Teeter Creek Herbs, Inc. 05/21/2013Kansas City District OfficeDietary Supplement/Labeling/False & Misleading Claims/Misbranded
Zi Xiu Tang Success, LLC 05/14/2013Philadelphia District OfficeUnapproved and Misbranded New Drugs
Entrenet Nutritionals, Inc. 05/08/2013Philadelphia District OfficeUnapproved and Misbranded New Drugs
American Natural Products Inc 05/02/2013Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Earthborn Products, Inc. 05/02/2013Los Angeles District OfficeNew Drug/Labeling/Misbranded
Alternative Health Supplements 05/02/2013Detroit District OfficeUnapproved and Misbranded New Drugs
Glucorell Inc./Anafit, Inc. 04/24/2013Florida District OfficeUnapproved and Misbranded New Drugs
Europharma Co., Inc. 04/24/2013Minneapolis District OfficeNew Drug/Labeling/False & Misleading Claims
Realm Labs, LLC 04/11/2013Florida District OfficeUnapproved and Misbranded New Drugs
Body Systems Inc 04/08/2013Florida District OfficeUnapproved and Misbranded New Drugs
The Glutathione Corporation 04/05/2013New York District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Natures Health Options LLC 04/02/2013Florida District OfficeUnapproved and Misbranded New Drugs
Juve International, LLC 04/02/2013Denver District OfficeNew Drug/Labeling/False & Misleading Claims
Birkdale Medicinals LLC 03/20/2013Detroit District OfficeUnapproved and Misbranded New Drugs
Sunset Natural Products 03/19/2013Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Synticare Corp 03/15/2013Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
Coral Rock Man, Inc. 03/13/2013Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Natural Medicine Associates, Inc 03/12/2013Florida District OfficeUnapproved and Misbranded New Drugs
Algaen Corporation 03/08/2013Atlanta District OfficeUnapproved New Drug/Adulterated/Misbranded
Altasource LLC DBA Metalabs LLC 02/25/2013Atlanta District OfficeUnapproved and Misbranded New Drugs
Laclede Inc 02/14/2013Los Angeles District OfficeCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Kreativ Health Inc Dba Natural Food Supplements 02/11/2013Los Angeles District OfficeCGMP/Manufacturing/Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Kosher Vitamin Express 02/11/2013Center for Food Safety and Applied NutritionUnapproved Products Related to the 2012/2013 Flu Season
Discount Online Pharmacy 02/11/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Medsnoscript 02/11/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Oasis Consumer Healthcare, LLC 02/11/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Sun Drug Store 02/11/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Supplementality LLC 02/11/2013Center for Food Safety and Applied NutritionUnapproved Products Related to the 2012/2013 Flu Season
Secure Medical Inc 02/11/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Vitalmax Vitamins 02/11/2013Center for Food Safety and Applied NutritionUnapproved Products Related to the 2012/2013 Flu Season
University of Berkley 02/07/2013Center for Biologics Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
Big Mountain Drugs 02/04/2013Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
buy-pharma.com 02/04/2013Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Liquid Health, Inc. 01/31/2013Los Angeles District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
M.D.R. Fitness Corp 01/29/2013Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Flu & Cold Defense LLC 01/24/2013Center for Drug Evaluation and ResearchUnapproved Products Related to the 2012/2013 Flu Season
  
 
Company NameLetter Issue Date Issuing OfficeSubject
ForMor, Inc. d/b/a ForMor International 12/21/2012Dallas District OfficeCGMP/Dietary Supplements/Adulterated
Amarc Enterprises 12/11/2012Los Angeles District OfficeNew Animal Drug/Adulterated
USPlabs, LLC 12/04/2012Dallas District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Emu Products and Management, Inc. (EPMI) 11/19/2012Dallas District OfficeNew Drug/Misbranded
Women's Health Institute of Texas 11/05/2012Dallas District OfficeNew Drug/Misbranded
The Avalon Effect 11/05/2012Center for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Atrium Inc. 11/02/2012Minneapolis District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Hail Merry, LLC 10/23/2012Dallas District OfficeFood Labeling/False & Misleading/Misbranded
Health Breakthroughs International, LLC 10/22/2012Seattle District OfficeInternet Marketing of Unapproved and Misbranded Drugs
Mushroom Wisdom 10/18/2012New Jersey District OfficeUnapproved and Misbranded New Drugs
Advanced Nutritional Technology Inc 10/16/2012San Francisco District OfficeCGMP/Dietary Supplement/Misbranding
Quincy Bioscience Manufacturing 10/16/2012Minneapolis District OfficeUnapproved and Misbranded New Drugs
Bioneurix 10/15/2012Los Angeles District OfficeDietary Supplement/Labeling/Misbranded
Ortho Molecular Products Inc 10/15/2012Minneapolis District OfficeNew Drug/Labeling/Misbranded
Garlic Rx 10/10/2012Cincinnati District OfficeNew Drug/Labeling/Misbranded
Food for Health International, LLC 10/05/2012Denver District OfficeCGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated
AHN International Inc DBA Amazing Herbs Nutraceuticals 10/02/2012Atlanta District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Healthy People Co 09/28/2012Los Angeles District OfficeUnapproved and Misbranded New Drugs
Andes Natural 09/21/2012Center for Food Safety and Applied NutritionNew Drug Application [NDA]
Canadadrugs 09/18/2012Center for Drug Evaluation and ResearchUnapproved and Misbranded New Drugs
Arkadiy Kisin/White Forest Solutions 09/18/2012Center for Drug Evaluation and ResearchUnapproved and Misbranded New Drugs
Eyal Bar Oz 09/18/2012Center for Drug Evaluation and ResearchUnapproved and Misbranded New Drugs
EyeScience Labs, L.L.C. 09/18/2012Cincinnati District OfficePromotional Claims False & Misleading/New Drugs
Global Source Management & Consulting 09/10/2012Florida District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
Regeneca, Inc. 08/28/2012Los Angeles District OfficeDietary Supplement/Adulterated
Trinity Sports Group, Inc. 08/28/2012Dallas District OfficeNew Drug/Labeling/Misbranded
Naturavit, Inc. 08/27/2012Florida District OfficeCGMP for Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded
PruTect Rx 08/27/2012New Orleans District OfficeNew Drug/Labeling/Misbranded
Mark's Marine Pharmacy 08/23/2012Center for Drug Evaluation and ResearchUnapproved and Misbranded New Drugs
Healing Ways 08/15/2012Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
Dragon Herbs 08/15/2012Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
HSAC Enterprises, Inc. dba Kare-N-Herbs 08/02/2012New England District OfficeDrug/Labeling/False & Misleading Claims
Bio Health Solutions 08/01/2012Florida District OfficeLabeling/False & Misleading Claims/Misbranded
Grato, Inc. 07/30/2012Kansas City District OfficeCGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded
Lithia Mineral Water, Inc. 07/20/2012Atlanta District OfficeDietary Supplement/Adulterated
Evol Nutrition Associates, Inc. 07/10/2012Atlanta District OfficeDietary Supplements/Food/New Drug/Adulterated/Misbranded
Prismic Light International 06/28/2012New Orleans District OfficeCGMP for Dietary Supplements/Adulterated/Misbranded
Alistrol Health 06/26/2012Seattle District OfficeNew Drug/Labeling/False & Misleading Claims/Misbranded
ABCO Laboratories, Inc. 06/19/2012San Francisco District OfficeDietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
Set-N-Me-Free Aloe Vera Co. 06/12/2012Seattle District OfficeNew Drug/Labeling/False & Misleading Claims/Misbranded
Michelle's Miracle, Inc. 06/08/2012Detroit District OfficeDietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
Oza Compound Products, LLC 06/07/2012Detroit District OfficeCGMP for Dietary Supplement/Adulterated/Misbranded
Best Price Rx 05/24/2012Center for Drug Evaluation and ResearchUnapproved/Misbranded New Drug
Northwest Pharmacy 05/24/2012Center for Drug Evaluation and ResearchUnapproved New Drug-Misbranded
Good Herbs, Inc. 05/24/2012Detroit District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Himalayan Int'l Inst. of Yoga Science and Phil. of the USA 05/23/2012Philadelphia District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Caribe Natural LLC 05/14/2012Florida District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Reaction Nutrition 05/08/2012Philadelphia District OfficeCGMP for Dietary Supplements/Adulterated/Misbranded
Quadex Pharmaceuticals 05/07/2012Denver District OfficeOTC Drug Labeling/New Drug/Misbranded
Vitality Distributing 04/24/2012Cincinnati District OfficeUnapproved New Drugs/Misbranded
Nature's Pearl Corporation 04/19/2012Atlanta District OfficeUnapproved New Drugs/Misbranded Dietary Supplements
From Fatigued to Fantastic, LLC 04/18/2012Baltimore District OfficeUnapproved New Drug Promotional Claims/Misbranded
Naprodis, Inc. 04/17/2012Los Angeles District OfficeLabeling/New Drug/Misbranded
Healing with Essaic Tea 04/12/2012Florida District OfficeFalse & Misleading Claims/New Drug
Leaner Living 04/04/2012Baltimore District OfficeUnapproved New Drug Promotional Claims/Misbranded
High Performance Formulas, L.L.C. (HPF, L.L.C) 03/22/2012Philadelphia District OfficeNew Drug/Labeling/Misbranded
Breathable Foods, Inc. 03/05/2012New England District Office

False & Misleading Claims/Misbranded

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

Homeopathic HCG Weight Loss Initiative - 6 letters

Sexually Transmitted Disease Fraud Initiative - 12 letters

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

Drug Products/Therapeutic Claims

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

Drug Products/Therapeutic Claims

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

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

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

Company Name

Letter Issue Date

Issuing Office

Subject

Unapproved Chelation Products Fraud Initiative - 8 letters

Prolatis

 12/02/2010

Denver District Office

Dietary Supplement/Adulterated

Shi Feng Zhang

 11/26/2010

Center for Food Safety and Applied Nutrition

False & Misleading Claims/Misbranded  

Vanderveer Center

 11/18/2010

Center for Drug Evaluation and Research

Misbranded/Labeling/Unauthorized Health Claims

Oxygen Therapy Program

 11/10/2010

Florida District Office

New Drug/False Misleading/Labeling/Misbranded 

Bioenergy, Inc.

 11/01/2010

Minneapolis District Office

Labeling/False & Misleading Claims/Misbranded

Vitality Products Company Inc

 11/01/2010

Philadelphia District Office

Misbranded/Labeling/Unauthorized Health Claims

Vita-Herb Nutriceuticals, Inc.

 10/20/2010

Los Angeles District Office

cGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated

Living Naturally

 10/15/2010

Florida District Office

New Drug/Adulterated/Misbranded

Telledant LLC

 09/28/2010

Center for Food Safety and Applied Nutrition

Dietary Supplement/Labeling False and Misleading/Misbranded 

Walgreen Company

 09/27/2010

Chicago District Office

New Drug/False Misleading Labeling 

CVS Pharmacy, Inc.

 09/27/2010

New England District Office

New Drug/False Misleading Labeling 

Johnson & Johnson Consumer Group of Companies, Inc.

 09/27/2010

New Jersey  District Office

New Drug/False Misleading Labeling 

Nature's Health Company, LLC 09/21/2010Center for Food Safety and Applied NutritionUnapproved New Drug/Lacks New Drug Application/Misbranded

Enriching Gifts International

 09/09/2010

Center for Food Safety and Applied Nutrition

Promotional Claims False & Misleading/New Drug

Gamucci

 09/08/2010

Center for Drug Evaluation and Research

Unapproved New Drug/Misbranded 

E-CigaretteDirect, LLC

 09/08/2010

Center for Drug Evaluation and Research

Unapproved New Drug/Misbranded 

Johnson Creek Enterprises, LLC

 09/08/2010

Center for Drug Evaluation and Research

Unapproved New Drug/ Misbranded/cGMP for Finished Pharmaceuticals 

E-Cig Technology Inc.

 09/08/2010

Center for Drug Evaluation and Research

Unapproved New Drug/Misbranded 

Ruyan America, Inc.

 09/08/2010

Center for Drug Evaluation and Research

Unapproved New Drug/Misbranded 

Unlimited Nutrition

 08/30/2010

Atlanta District Office

Dietary Supplement/ Labeling/Misbranded 

Specialty Brands of America

 08/25/2010

Center for Food Safety and Applied Nutrition

Federal Food, Drug and Cosmetic Act/Misbranded 

INZ Distributors Inc. / Magic Power Coffee Inc.

 08/23/2010

New York District Office

Unapproved New Drug/Misbranded 

Unilever United States, Inc.

 08/23/2010

Center for Food Safety and Applied Nutrition

Promotional Claims False & Misleading/
New Drug/Misbranded 

Haw Par Healthcare Limited

 07/20/2010

Division of Manufacturing and Product Quality

cGMP Violations and Misbranded

RT Naturals, LLC

 07/15/2010

Los Angeles District Office

Unapproved New Drug/Misbranded 

Florida Bottling, Inc.

 07/08/2010

Florida District Office

New Drug/Drug Labeling/Misbranded

Steril Aire

 07/02/2010

Center for Devices and Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Cti Science, Inc.

 06/17/2010

Cincinnati District Office

Dietary Supplement/Labeling False and Misleading/Misbranded

Libido Edge Labs, LLC

 06/10/2010

Cincinnati District Office

Unapproved New Drug Promotional Claims/Misbranded

Homeopathy for Health (FDA/FTC)

 06/08/2010

Center for Drug Evaluation and Research

Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus 

Cogent Solutions Group LLC 05/12/2010Cincinnati District OfficeNew Drug/Labeling/Misbranded

Healthy World Distributing, LLC. 

 05/11/2010

Seattle District Office

Promotional Claims/Misbranded

Pure Med Spa

 04/06/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading Claims/Misbranded

Aloha Medicinals Inc

 04/06/2010

San Francisco District Office

New Animal Drug/Labeling/Misbranded/Adulterated

Medical Cosmetic Enhancements

 04/05/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading  Claims/Misbranded

All About You Medspa, LLC

 04/05/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading Claims/Misbranded

7Seas LLC

 04/05/2010

Florida District Office

Dietary Supplement Regulations/
Misbranded

Monarch Med Spa

 04/05/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading Claims/Misbranded

Innovative Directions in Health

 04/05/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading Claims/Misbranded

Spa 35

 04/05/2010

Center for Drug Evaluation and Research

Lipodissolve/False & Misleading Claims/Misbranded

Amerilab Technologies, Inc

 03/16/2010

Minneapolis District Office

Labeling/New Drug/Misbranded

Healthy Body Forero

 03/15/2010

San Juan District

New Drug/Labeling/
False & Misleading Claims/Misbranded

Pom Wonderful

 02/23/2010

Center for Food Safety and Applied Nutrition

Labeling/False & Misleading Claims/
Adulterated/Misbranded

Diamond Food Inc. 02/22/2010Center for Food Safety and Applied NutritionLabeling/False & Misleading Claims/Adulterated/Misbranded

Pompeian, Inc 

 02/22/2010

Center for Food Safety and Applied Nutrition

Labeling/False & Misleading Claims/Adulterated/
Misbranded

Fleminger Inc

 02/22/2010

Center for Food Safety and Applied Nutrition

Labeling/False & Misleading Claims/Adulterated/
Misbranded

Body Tools

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/Misbranded 

Home Remedies Solutions

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Wally's Natural Products, Inc.

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

International Ear Candle, LLC

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Wholistic Health Solutions

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Harmony Cone

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Indian Mountain Center

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Bobalee Originals Manufacturing

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

White Egret, Inc.

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Herbs, Heirlooms and Homebrew

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Amasha

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

A.J.'s Candles, Inc

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Health, Wealth, & Happiness

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Brennan and Mccoy

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

King Cone International

 02/17/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Innovative Beverage Group,Inc.

 01/13/2010

Dallas District Office

Labeling/Adulterated

Holistic Healing Devices

 01/11/2010

Center for Devices and  Radiological Health

Premarket Approval/Adulterated/ Misbranded 

Innovative Beverage Groups Holdings, Inc 01/13/2010Dallas District OfficeLabeling/Adulterated

Cerebral Health, LLC

 01/07/2010

Florida District Office

Labeling/False & Misleading Claims/New Drugs

  
 
Company NameLetter Issue DateIssuing OfficeSubject
www.sharco.tv 12/09/2009Center for Biologics Evaluation and ResearchBiological Products Standards
Nestle Healthcare Nutrition 12/03/2009Center for Food Safety and Applied NutritionLabeling/False & Misleading
Claims/Misbranded
Aluwe, LLC 11/30/2009Minneapolis District OfficeUnapproved New Drug/Misbranded
Pan American Labs, LLC 11/20/2009Center for Food Safety and Applied NutritionDietary Supplement/Labeling/False
& Misleading Claims/Misbranded
Wellspring International, Inc. 11/20/2009Minneapolis District OfficeUnapproved New Drug
Chris Walsh, c/o Dynadot Privacy 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Petroff, Andrey 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
New Horizons LTD 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
tvforever 11/16/2009Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
BUZZ, LLC 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Randek I-warez 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Med Light Ltd 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Lorna Hillier 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Krest Holdings, Panama S.A. 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Akyuz, Sinan 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
onlinepharmacyy.com 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Ric Deleon 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Xanos Holdings Inc. 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Mendez, Dr Antonio 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Chen-Yu Ou 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
William Wynne 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Pro West Marketing Ltd. 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Hunter, D 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Orion Star and Associates Inc 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Forrest Media Incorporated 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Sinan Akyuz (goask.org) 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Eugene Lefter 11/16/2009Center for Drug Evaluation and ResearchUnapproved New Drug/Misbranded
Dynamic Nutritional Associates 11/06/2009Seattle District OfficeLabeling/False & Misleading
Claims/Misbranded
Shire Pharmaceuticals 11/05/2009Marketing, Advertising, and CommunicationsLabeling/False & Misleading
Claims/Misbranded
Procter and Gamble 10/29/2009Center for Drug Evaluation and ResearchOTC Drug Products/Dietary Supplements
Washington Homeopathic Products, Inc 10/06/2009Center for Biologics Evaluation and ResearchUnapproved New Drug/Misbranded/False
or Misleading
Platinum Strategies, Inc. 09/23/2009Detroit District OfficeLabeling/Promotional Claims False
& Misleading/New Drug/Misbranded
Mountain Meadow Herbs, Inc. 09/21/2009Seattle District OfficeLabeling/New Drug/Misbranded
EFT Inc. 08/19/2009Los Angeles District OfficeDietary Supplements/Adulterated/
Misbranded/Labeling
Meditrend, Inc. 08/18/2009Denver District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Core Products Int'L Inc 08/18/2009Minneapolis District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Wonder Laboratories 08/18/2009New Orleans District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
BioCentrc Laboratories Inc. 08/18/2009Denver District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
METK LLC 08/18/2009New Jersey District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Geromatrix Nutraceutical Corporation 08/18/2009Florida District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Progressive Emu Inc. 08/18/2009New Orleans District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Ridge Medical Products 08/11/2009Dallas District OfficeOTC Drug Products/Lacks New
Drug Approval/ Misbranded
Synflex America Inc 07/30/2009Florida District OfficeNew Drug/Adulterated
Bodee LLC 07/27/2009Los Angeles District OfficeDietary Supplement/ Labeling False
and Misleading/ Misbranded
Americell-labs.com VMG Global Inc 07/27/2009San Francisco District OfficeDietary Supplements/Adulterated/Misbranded
www.balanceayurvedic.com 07/09/2009Los Angeles District OfficePromotional Claims False &
Misleading/Misbranded
Bazaar of India 07/07/2009San Francisco District OfficeNew Drug/Labeling/Misbranded
Banyan Botanicals 06/29/2009Denver District OfficeNew Drug/Labeling/Misbranded
Circle of Health, Inc www.ayurveda-herbs.com 06/12/2009Seattle District OfficeNew Drug/Labeling/Misbranded
DS Waters of America, LP 06/08/2009Center for Food Safety and Applied NutritionMisbranded/Labeling/Unauthorized
Health Claims
InspiredLiving.com 06/02/2009Seattle District OfficeNew Drugs, Unapproved/Labeling/
Misbranded
Samglo Enterprises 05/07/2009Detroit District OfficePromotional Claims False &
Misleading/ Misbranded
General Mills 05/05/2009Minneapolis District OfficePromotional Claims False &
Misleading/ Misbranded
Syntec Nutraceuticals, Inc 03/13/2009Minneapolis District OfficePromotional Claims False &
Misleading/ Misbranded
BestLife International, Inc 02/04/2009Seattle District OfficeNew Drug/Labeling/False &
Misleading Claims
Haelan Products 01/15/2009Seattle District OfficePromotional Claims False & Misleading/New Drug/Misbranded
Healthy Origins 01/14/2009Philadelphia District OfficeLabeling/False & Misleading
Claims/New Drug/ Misbranded
South Beach Supplements 01/09/2009Florida District OfficeLabeling/False &  Misleading
Claims/New Drug
US Lab Research, Inc 01/06/2009Cincinnati District OfficeLabeling/Promotional Claims
False & Misleading/New Drug
True Renewal 01/06/2009Denver District OfficePromotional Claims False &
Misleading/New Drugs
BodySaver, LLC 01/05/2009Florida District OfficeNew Drug/Labeling/False &
Misleading Claims/ Misbranded
  
 

2008

Company NameLetter Issue DateIssuing OfficeSubject

Fake Cancer Cures Fraud Initiative

Fake Cancer Cures Fraud Initiative Warning Letters - 29 letters

Goosefoot Acres, Inc. 11/19/2008Cincinnati District OfficeLabeling/False & Misleading Claims/New Drug/Misbranded
RHG & Company, Inc., dba Vital Nutrients 11/18/2008New England District OfficeNew Drug/Labeling/False & Misleading Claims/ Misbranded
Aerosol Science Laboratories Inc. 10/29/2008Center for Drug Evaluation and ResearchFalse & Misleading Claims/New Drug/Misbranded
Sleeping Bear Apiaries 10/27/2008Detroit District OfficePromotional Claims False & Misleading/ Misbranded
Natural Biology, Inc. 10/09/2008Atlanta District OfficeNew Drug/Labeling/False & Misleading
Claims/Misbranded
Renewal Research 09/25/2008San Francisco District OfficePromotional Claims False & Misleading/ Adulterated/Misbranded
Omega Supply 09/17/2008Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
Health Center for Better Living, Inc. 08/22/2008Florida District OfficeNew Drug/Labeling/False & Misleading Claims
SeniorLife Health Inc. 08/21/2008Los Angeles District OfficeNew Drug/Labeling/False & Misleading Claims
Daniel Chapter One Inc 08/15/2008New England District OfficeNew Drug/Labeling/False & Misleading Claims
LifeGuard Health LLC 07/29/2008Center for Food Safety and Applied NutritionPromotional Claims False & Misleading/New Drugs
Sharp Labs Inc 07/09/2008Florida District OfficeNew Drug/Labeling/False & Misleading Claims
Tattva's Herbs, LLC 07/09/2008Seattle District OfficePromotional Claims False & Misleading/Misbranded
Newman Inc., (dba Medi-Stat) 06/24/2008New Orleans District OfficeNew Drug/Adulterated/Misbranded
NaturesAlternatives.com 06/02/2008Los Angeles District OfficePromotional Claims/False & Misleading
Dherbs.com 06/02/2008Los Angeles District OfficeNew Drug/Labeling/False Promotional Statements/Misbranded
Teeter Creek Herbs Company 05/19/2008Kansas City District OfficePromotional Claims/False & Misleading/Misbranded
Gemtronics Inc 04/17/2008Atlanta District OfficeNew Drug/Labeling/False & Misleading Claims
Hato Potrero Farm, Inc 04/03/2008Florida District OfficePromotional Claims False & Misleading/New Drug/Misbranded
Laser Therapeutics 03/21/2008New England District OfficePremarket Approval/Misbranded/Adulterated
Saferex Laboratories International Corporations 03/04/2008Dallas District OfficeNew Drug/False Misleading/Labeling/ Misbranded
McKinnon, Blair 03/04/2008Center for Drug Evaluation and ResearchNew Drug/False Misleading/Labeling/ Misbranded
NeumaLife 03/04/2008Kansas City District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Health-science-report.com 03/04/2008Seattle District OfficeDietary Supplement/Labeling/False & Misleading Claims/Misbranded
IMULUX, LLC 03/04/2008Dallas District OfficeNew Drug/False Misleading/Labeling/Misbranded
Aidance Skincare & Topical Solutions, LLC 03/03/2008New England District OfficeDrug Labeling/Promotional Claims/ Misbranded
Aviralex Int. 03/03/2008San Francisco District OfficeDrug Labeling/Promotional Claims/ Misbranded
Herbal Hope, Inc. 02/25/2008Center for Food Safety and Applied NutritionNew Drug/Labeling/False & Misleading Claims
International Pharmaceutical Corporation 02/07/2008Center for Food Safety and Applied NutritionDrug Labeling/Promotional Claims/Misbranded
Nature's Way Products, Inc. 01/25/2008Denver District OfficeDietary Supplements/Food/New Drug/
Adulterated/Misbranded
Bellevue Pharmacy Solution 01/14/2008Kansas City District OfficePromotional Claims False & Misleading/Misbranded
Panorama Compounding Pharmacy 01/07/2008Los Angeles District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Saint John's Medical Plaza Pharmacy 01/07/2008Los Angeles District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Reed's Compounding Pharmacy 01/07/2008Los Angeles District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Pharmacy Compounding Specialties 01/07/2008Dallas District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Pacifica Pharmacy 01/07/2008Los Angeles District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Murray Avenue Apothecary 01/07/2008Philadelphia District OfficeNew Drug/False Misleading/Labeling/ Misbranded
Village Compounding Pharmacy 01/07/2008Dallas District OfficeNew Drug/False Misleading/Labeling/ Misbranded
  
 

2007

 Company NameLetter Issue DateIssuing OfficeSubject
Heartland Products, Inc. 10/22/2007Minneapolis District OfficeMisbranded/Labeling/Unauthorized Health Claims
Health Freedom Nutrition, LLC 10/16/2007San Francisco District OfficeMisbranded/Labeling/
Unauthorized Health Claims
Health MarketPlace.com 10/16/2007Baltimore District OfficeLabeling Claims
Biotivia America 10/15/2007Center for Food Safety and Applied NutritionLabeling Claims
Jen-On Herbal Science Intl 10/12/2007Los Angeles District OfficeDietary Supplement/Labeling False and Misleading/Misbranded
Efficas 09/28/2007Center for Food Safety and Applied NutritionLabeling & Promotional Claims
Alternative Health Approaches 09/24/2007Los Angeles District OfficeDrug Labeling/Promotional Claims/Misbranded
Procter and Gamble 09/14/2007Cincinnati District OfficeLabeling/OTC Drugs
F.H.G. Corporation 08/22/2007Florida District OfficePromotional Claims/Misbranded
Vigor Nutriceutical Healthcare 08/20/2007Minneapolis District OfficeMisbranded/Labeling/Unauthorized Health Claims
Hain Celestial Group Inc. 8/17/2007Center for Food Safety and Applied NutritionDietary Supplement/Adulterated
Swanson Health Products 08/08/2007Minneapolis District OfficeDietary Supplements
Novis PR dba Kramer-Novis 08/08/2007San Juan District OfficeOTC Drug Products/Dietary Supplements/
Misbranded
Sunburst Biogranics 08/07/2007New York District OfficeDietary Supplements
Schering-Plough Animal Health Corporation 07/11/2007Center for Veterinary MedicinePromotional Claims/False & Misleading/ Misbranded
Zeo Health Ltd. 06/29/2007Center for Food Safety and Applied NutritionNew Drugs/Claims
Merial Limited 06/21/2007Center for Veterinary MedicinePromotional Claims/New Drug/Misbranded
Heska Corporation 06/05/2007Center for Veterinary MedicinePromotional Claims False & Misleading/ Misbranded
TheraLife, Inc. 06/01/2007Center for Food Safety and Applied NutritionLabeling/False & Misleading Claims/New Drug/Misbranded
Panacea Products, LLC 05/24/2007New Orleans District OfficeNew Drug/Labeling/False & Misleading Claims
Fusion Brands International SRL 04/24/2007New Jersey District OfficeDrug Products/Labeling
Langers Juice Co. 04/17/2007Los Angeles District OfficeMisbranded/Labeling/Unauthorized Health Claims
Redux Beverages, LLC 04/04/2007Los Angeles District OfficeDietary Supplement/Labeling/False & Misleading Claims/Misbranded
Freedom Plus Corporation 03/29/2007San Francisco District OfficeDietary Supplement/Adulterated
Beehive Botanicals, Inc. 03/02/2007Minneapolis District OfficeDietary Supplements
BioForm Medical, Inc. 02/17/2007Minneapolis District OfficeLabeling Drug Claims
Alternative Health & Herbs Remedies 01/16/2007Seattle District OfficeNew Drugs
  

  

*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.