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 Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
| Entrenet Nutritionals, Inc. | 05/08/2013 | Philadelphia District Office | Unapproved and Misbranded New Drugs |
| Alternative Health Supplements | 05/02/2013 | Detroit District Office | Unapproved and Misbranded New Drugs |
| Glucorell Inc./Anafit, Inc. | 04/24/2013 | Florida District Office | Unapproved and Misbranded New Drugs |
| Europharma Co., Inc. | 04/24/2013 | Minneapolis District Office | New Drug/Labeling/False & Misleading Claims |
| Realm Labs, LLC | 04/11/2013 | Florida District Office | Unapproved and Misbranded New Drugs |
| Body Systems Inc | 04/08/2013 | Florida District Office | Unapproved and Misbranded New Drugs |
| The Glutathione Corporation | 04/05/2013 | New York District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Natures Health Options LLC | 04/02/2013 | Florida District Office | Unapproved and Misbranded New Drugs |
| Juve International, LLC | 04/02/2013 | Denver District Office | New Drug/Labeling/False & Misleading Claims |
| Birkdale Medicinals LLC | 03/20/2013 | Detroit District Office | Unapproved and Misbranded New Drugs |
| Sunset Natural Products | 03/19/2013 | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Synticare Corp | 03/15/2013 | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims |
| Coral Rock Man, Inc. | 03/13/2013 | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Natural Medicine Associates, Inc | 03/12/2013 | Florida District Office | Unapproved and Misbranded New Drugs |
| Laclede Inc | 02/14/2013 | Los Angeles District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Kreativ Health Inc Dba Natural Food Supplements | 02/11/2013 | Los Angeles District Office | CGMP/Manufacturing/Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Kosher Vitamin Express | 02/11/2013 | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season |
| Discount Online Pharmacy | 02/11/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Medsnoscript | 02/11/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Oasis Consumer Healthcare, LLC | 02/11/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Sun Drug Store | 02/11/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Supplementality LLC | 02/11/2013 | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season |
| Secure Medical Inc | 02/11/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Vitalmax Vitamins | 02/11/2013 | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season |
| University of Berkley | 02/07/2013 | Center for Biologics Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Big Mountain Drugs | 02/04/2013 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| buy-pharma.com | 02/04/2013 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Liquid Health, Inc. | 01/31/2013 | Los Angeles District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| M.D.R. Fitness Corp | 01/29/2013 | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Flu & Cold Defense LLC | 01/24/2013 | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season |
| Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
| ForMor, Inc. d/b/a ForMor International | 12/21/2012 | Dallas District Office | CGMP/Dietary Supplements/Adulterated |
| Amarc Enterprises | 12/11/2012 | Los Angeles District Office | New Animal Drug/Adulterated |
| USPlabs, LLC | 12/04/2012 | Dallas District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Emu Products and Management, Inc. (EPMI) | 11/19/2012 | Dallas District Office | New Drug/Misbranded |
| Women's Health Institute of Texas | 11/05/2012 | Dallas District Office | New Drug/Misbranded |
| The Avalon Effect | 11/05/2012 | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Atrium Inc. | 11/02/2012 | Minneapolis District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Hail Merry, LLC | 10/23/2012 | Dallas District Office | Food Labeling/False & Misleading/Misbranded |
| Health Breakthroughs International, LLC | 10/22/2012 | Seattle District Office | Internet Marketing of Unapproved and Misbranded Drugs |
| Mushroom Wisdom | 10/18/2012 | New Jersey District Office | Unapproved and Misbranded New Drugs |
| Advanced Nutritional Technology Inc | 10/16/2012 | San Francisco District Office | CGMP/Dietary Supplement/Misbranding |
| Quincy Bioscience Manufacturing | 10/16/2012 | Minneapolis District Office | Unapproved and Misbranded New Drugs |
| Bioneurix | 10/15/2012 | Los Angeles District Office | Dietary Supplement/Labeling/Misbranded |
| Ortho Molecular Products Inc | 10/15/2012 | Minneapolis District Office | New Drug/Labeling/Misbranded |
| Garlic Rx | 10/10/2012 | Cincinnati District Office | New Drug/Labeling/Misbranded |
| Food for Health International, LLC | 10/05/2012 | Denver District Office | CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated |
| AHN International Inc DBA Amazing Herbs Nutraceuticals | 10/02/2012 | Atlanta District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Healthy People Co | 09/28/2012 | Los Angeles District Office | Unapproved and Misbranded New Drugs |
| Andes Natural | 09/21/2012 | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] |
| Canadadrugs | 09/18/2012 | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs |
| Arkadiy Kisin/White Forest Solutions | 09/18/2012 | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs |
| Eyal Bar Oz | 09/18/2012 | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs |
| EyeScience Labs, L.L.C. | 09/18/2012 | Cincinnati District Office | Promotional Claims False & Misleading/New Drugs |
| Global Source Management & Consulting | 09/10/2012 | Florida District Office | New Drugs/Dietary Supplements/Food Labeling/Misbranded |
| Regeneca, Inc. | 08/28/2012 | Los Angeles District Office | Dietary Supplement/Adulterated |
| Trinity Sports Group, Inc. | 08/28/2012 | Dallas District Office | New Drug/Labeling/Misbranded |
| Naturavit, Inc. | 08/27/2012 | Florida District Office | CGMP for Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated/Misbranded |
| PruTect Rx | 08/27/2012 | New Orleans District Office | New Drug/Labeling/Misbranded |
| Mark's Marine Pharmacy | 08/23/2012 | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs |
| Healing Ways | 08/15/2012 | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims |
| Dragon Herbs | 08/15/2012 | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims |
| HSAC Enterprises, Inc. dba Kare-N-Herbs | 08/02/2012 | New England District Office | Drug/Labeling/False & Misleading Claims |
| Bio Health Solutions | 08/01/2012 | Florida District Office | Labeling/False & Misleading Claims/Misbranded |
| Grato, Inc. | 07/30/2012 | Kansas City District Office | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded |
| Lithia Mineral Water, Inc. | 07/20/2012 | Atlanta District Office | Dietary Supplement/Adulterated |
| Evol Nutrition Associates, Inc. | 07/10/2012 | Atlanta District Office | Dietary Supplements/Food/New Drug/Adulterated/Misbranded |
| Prismic Light International | 06/28/2012 | New Orleans District Office | CGMP for Dietary Supplements/Adulterated/Misbranded |
| Alistrol Health | 06/26/2012 | Seattle District Office | New Drug/Labeling/False & Misleading Claims/Misbranded |
| ABCO Laboratories, Inc. | 06/19/2012 | San Francisco District Office | Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded |
| Set-N-Me-Free Aloe Vera Co. | 06/12/2012 | Seattle District Office | New Drug/Labeling/False & Misleading Claims/Misbranded |
| Michelle's Miracle, Inc. | 06/08/2012 | Detroit District Office | Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded |
| Oza Compound Products, LLC | 06/07/2012 | Detroit District Office | CGMP for Dietary Supplement/Adulterated/Misbranded |
| Best Price Rx | 05/24/2012 | Center for Drug Evaluation and Research | Unapproved/Misbranded New Drug |
| Northwest Pharmacy | 05/24/2012 | Center for Drug Evaluation and Research | Unapproved New Drug-Misbranded |
| Good Herbs, Inc. | 05/24/2012 | Detroit District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Himalayan Int'l Inst. of Yoga Science and Phil. of the USA | 05/23/2012 | Philadelphia District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Caribe Natural LLC | 05/14/2012 | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Reaction Nutrition | 05/08/2012 | Philadelphia District Office | CGMP for Dietary Supplements/Adulterated/Misbranded |
| Quadex Pharmaceuticals | 05/07/2012 | Denver District Office | OTC Drug Labeling/New Drug/Misbranded |
| Vitality Distributing | 04/24/2012 | Cincinnati District Office | Unapproved New Drugs/Misbranded |
| Nature's Pearl Corporation | 04/19/2012 | Atlanta District Office | Unapproved New Drugs/Misbranded Dietary Supplements |
| From Fatigued to Fantastic, LLC | 04/18/2012 | Baltimore District Office | Unapproved New Drug Promotional Claims/Misbranded |
| Naprodis, Inc. | 04/17/2012 | Los Angeles District Office | Labeling/New Drug/Misbranded |
| Healing with Essaic Tea | 04/12/2012 | Florida District Office | False & Misleading Claims/New Drug |
| Leaner Living | 04/04/2012 | Baltimore District Office | Unapproved New Drug Promotional Claims/Misbranded |
| High Performance Formulas, L.L.C. (HPF, L.L.C) | 03/22/2012 | Philadelphia District Office | New Drug/Labeling/Misbranded |
| Breathable Foods, Inc. | 03/05/2012 | New England District Office | False & Misleading Claims/Misbranded |
| Schwabe North America, Inc. | 02/15/2012 | Minneapolis District Office | Unapproved New Drug/Misbranded |
| BioAnue Laboratories, Inc. | 02/09/2012 | Atlanta District Office | Dietary Supplement/New Drug |
| Globe All Wellness, LLC | 02/06/2012 | Florida District Office | New Drugs/Dietary Supplements/Misbranded |
| Mushroom Wisdom | 01/19/2012 | New Jersey District Office | False & Misleading Claims/New Drug |
| Formulife, Inc. Purus Labs, Inc. d.b.a. Dark Cyde Supplements | 01/18/2012 | Dallas District Office | Dietary Supplements/Food/New Drug/Adulterated/Misbranded |
| Agora Publishing | 01/10/2012 | Baltimore District Office | New Drug/Labeling/Misbranded |
| Almased USA, Inc. | 01/18/2012 | Florida District Office | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded |
| Royal Domains | 01/06/2012 | Atlanta District Office | Unapproved New Drugs/Misbranded Dietary Supplements |
| Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
| Natural Health Team | 12/28/2011 | New Orleans District Office | Unapproved New Drug |
| 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 | Homeopathic HCG 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 | Promotional Claims 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 New Drugs |
| 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 | Los Angeles 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 Ooffice | 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 | San Juan 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 |
| Lesa Sverid | 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 & Herb dba 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 | New England District Office | 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 |
Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
12/02/2010 | Denver District Office | Dietary Supplement/Adulterated | |
11/26/2010 | Center for Food Safety and Applied Nutrition | False & Misleading Claims/Misbranded | |
11/18/2010 | Center for Drug Evaluation and Research | Misbranded/Labeling/Unauthorized Health Claims | |
11/10/2010 | Florida District Office | New Drug/False Misleading/Labeling/Misbranded | |
11/01/2010 | Minneapolis District Office | Labeling/False & Misleading Claims/Misbranded | |
11/01/2010 | Philadelphia District Office | Misbranded/Labeling/Unauthorized Health Claims | |
10/20/2010 | Los Angeles District Office | cGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated | |
10/15/2010 | Florida District Office | New Drug/Adulterated/Misbranded | |
09/28/2010 | Center for Food Safety and Applied Nutrition | Dietary Supplement/Labeling False and Misleading/Misbranded | |
09/27/2010 | Chicago District Office | New Drug/False Misleading Labeling | |
09/27/2010 | New England District Office | New Drug/False Misleading Labeling | |
09/27/2010 | New Jersey District Office | New Drug/False Misleading Labeling | |
| Nature's Health Company, LLC | 09/21/2010 | Center for Food Safety and Applied Nutrition | Unapproved New Drug/Lacks New Drug Application/Misbranded |
09/09/2010 | Center for Food Safety and Applied Nutrition | Promotional Claims False & Misleading/New Drug | |
09/08/2010 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | |
09/08/2010 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | |
09/08/2010 | Center for Drug Evaluation and Research | Unapproved New Drug/ Misbranded/cGMP for Finished Pharmaceuticals | |
09/08/2010 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | |
09/08/2010 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | |
08/30/2010 | Atlanta District Office | Dietary Supplement/ Labeling/Misbranded | |
08/25/2010 | Center for Food Safety and Applied Nutrition | Federal Food, Drug and Cosmetic Act/Misbranded | |
08/23/2010 | New York District Office | Unapproved New Drug/Misbranded | |
08/23/2010 | Center for Food Safety and Applied Nutrition | Promotional Claims False & Misleading/ | |
07/20/2010 | Division of Manufacturing and Product Quality | cGMP Violations and Misbranded | |
07/15/2010 | Los Angeles District Office | Unapproved New Drug/Misbranded | |
07/08/2010 | Florida District Office | New Drug/Drug Labeling/Misbranded | |
07/02/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
06/17/2010 | Cincinnati District Office | Dietary Supplement/Labeling False and Misleading/Misbranded | |
06/10/2010 | Cincinnati District Office | Unapproved New Drug Promotional Claims/Misbranded | |
06/08/2010 | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | |
| Cogent Solutions Group LLC | 05/12/2010 | Cincinnati District Office | New Drug/Labeling/Misbranded |
05/11/2010 | Seattle District Office | Promotional Claims/Misbranded | |
04/06/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
04/06/2010 | San Francisco District Office | New Animal Drug/Labeling/Misbranded/Adulterated | |
04/05/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
04/05/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
04/05/2010 | Florida District Office | Dietary Supplement Regulations/ | |
04/05/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
04/05/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
04/05/2010 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | |
03/16/2010 | Minneapolis District Office | Labeling/New Drug/Misbranded | |
03/15/2010 | San Juan District | New Drug/Labeling/ | |
02/23/2010 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/ | |
| Diamond Food Inc. | 02/22/2010 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Adulterated/Misbranded |
02/22/2010 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Adulterated/ | |
02/22/2010 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Adulterated/ | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
02/17/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
01/13/2010 | Dallas District Office | Labeling/Adulterated | |
01/11/2010 | Center for Devices and Radiological Health | Premarket Approval/Adulterated/ Misbranded | |
| Innovative Beverage Groups Holdings, Inc | 01/13/2010 | Dallas District Office | Labeling/Adulterated |
01/07/2010 | Florida District Office | Labeling/False & Misleading Claims/New Drugs | |
| Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
| www.sharco.tv | 12/09/2009 | Center for Biologics Evaluation and Research | Biological Products Standards |
| Nestle Healthcare Nutrition | 12/03/2009 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Misbranded |
| Aluwe, LLC | 11/30/2009 | Minneapolis District Office | Unapproved New Drug/Misbranded |
| Pan American Labs, LLC | 11/20/2009 | Center for Food Safety and Applied Nutrition | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded |
| Wellspring International, Inc. | 11/20/2009 | Minneapolis District Office | Unapproved New Drug |
| Chris Walsh, c/o Dynadot Privacy | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Petroff, Andrey | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| New Horizons LTD | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| tvforever | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| BUZZ, LLC | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Randek I-warez | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Med Light Ltd | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Lorna Hillier | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Krest Holdings, Panama S.A. | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Akyuz, Sinan | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| onlinepharmacyy.com | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Ric Deleon | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Xanos Holdings Inc. | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Mendez, Dr Antonio | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Chen-Yu Ou | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| William Wynne | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Pro West Marketing Ltd. | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Hunter, D | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Orion Star and Associates Inc | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Forrest Media Incorporated | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Sinan Akyuz (goask.org) | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Eugene Lefter | 11/16/2009 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| Dynamic Nutritional Associates | 11/06/2009 | Seattle District Office | Labeling/False & Misleading Claims/Misbranded |
| Shire Pharmaceuticals | 11/05/2009 | Marketing, Advertising, and Communications | Labeling/False & Misleading Claims/Misbranded |
| Procter and Gamble | 10/29/2009 | Center for Drug Evaluation and Research | OTC Drug Products/Dietary Supplements |
| Washington Homeopathic Products, Inc | 10/06/2009 | Center for Biologics Evaluation and Research | Unapproved New Drug/Misbranded/False or Misleading |
| Platinum Strategies, Inc. | 09/23/2009 | Detroit District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded |
| Mountain Meadow Herbs, Inc. | 09/21/2009 | Seattle District Office | Labeling/New Drug/Misbranded |
| EFT Inc. | 08/19/2009 | Los Angeles District Office | Dietary Supplements/Adulterated/ Misbranded/Labeling |
| Meditrend, Inc. | 08/18/2009 | Denver District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Core Products Int'L Inc | 08/18/2009 | Minneapolis District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Wonder Laboratories | 08/18/2009 | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| BioCentrc Laboratories Inc. | 08/18/2009 | Denver District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| METK LLC | 08/18/2009 | New Jersey District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Geromatrix Nutraceutical Corporation | 08/18/2009 | Florida District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Progressive Emu Inc. | 08/18/2009 | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Ridge Medical Products | 08/11/2009 | Dallas District Office | OTC Drug Products/Lacks New Drug Approval/ Misbranded |
| Synflex America Inc | 07/30/2009 | Florida District Office | New Drug/Adulterated |
| Bodee LLC | 07/27/2009 | Los Angeles District Office | Dietary Supplement/ Labeling False and Misleading/ Misbranded |
| Americell-labs.com VMG Global Inc | 07/27/2009 | San Francisco District Office | Dietary Supplements/Adulterated/Misbranded |
| www.balanceayurvedic.com | 07/09/2009 | Los Angeles District Office | Promotional Claims False & Misleading/Misbranded |
| Bazaar of India | 07/07/2009 | San Francisco District Office | New Drug/Labeling/Misbranded |
| Banyan Botanicals | 06/29/2009 | Denver District Office | New Drug/Labeling/Misbranded |
| Circle of Health, Inc www.ayurveda-herbs.com | 06/12/2009 | Seattle District Office | New Drug/Labeling/Misbranded |
| DS Waters of America, LP | 06/08/2009 | Center for Food Safety and Applied Nutrition | Misbranded/Labeling/Unauthorized Health Claims |
| InspiredLiving.com | 06/02/2009 | Seattle District Office | New Drugs, Unapproved/Labeling/ Misbranded |
| Samglo Enterprises | 05/07/2009 | Detroit District Office | Promotional Claims False & Misleading/ Misbranded |
| General Mills | 05/05/2009 | Minneapolis District Office | Promotional Claims False & Misleading/ Misbranded |
| Syntec Nutraceuticals, Inc | 03/13/2009 | Minneapolis District Office | Promotional Claims False & Misleading/ Misbranded |
| BestLife International, Inc | 02/04/2009 | Seattle District Office | New Drug/Labeling/False & Misleading Claims |
| Haelan Products | 01/15/2009 | Seattle District Office | Promotional Claims False & Misleading/New Drug/Misbranded |
| Healthy Origins | 01/14/2009 | Philadelphia District Office | Labeling/False & Misleading Claims/New Drug/ Misbranded |
| South Beach Supplements | 01/09/2009 | Florida District Office | Labeling/False & Misleading Claims/New Drug |
| US Lab Research, Inc | 01/06/2009 | Cincinnati District Office | Labeling/Promotional Claims False & Misleading/New Drug |
| True Renewal | 01/06/2009 | Denver District Office | Promotional Claims False & Misleading/New Drugs |
| BodySaver, LLC | 01/05/2009 | Florida District Office | New Drug/Labeling/False & Misleading Claims/ Misbranded |
2008
| Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
Fake Cancer Cures Fraud Initiative Fake Cancer Cures Fraud Initiative Warning Letters - 29 letters | |||
| Goosefoot Acres, Inc. | 11/19/2008 | Cincinnati District Office | Labeling/False & Misleading Claims/New Drug/Misbranded |
| RHG & Company, Inc., dba Vital Nutrients | 11/18/2008 | New England District Office | New Drug/Labeling/False & Misleading Claims/ Misbranded |
| Aerosol Science Laboratories Inc. | 10/29/2008 | Center for Drug Evaluation and Research | False & Misleading Claims/New Drug/Misbranded |
| Sleeping Bear Apiaries | 10/27/2008 | Detroit District Office | Promotional Claims False & Misleading/ Misbranded |
| Natural Biology, Inc. | 10/09/2008 | Atlanta District Office | New Drug/Labeling/False & Misleading Claims/Misbranded |
| Renewal Research | 09/25/2008 | San Francisco District Office | Promotional Claims False & Misleading/ Adulterated/Misbranded |
| Omega Supply | 09/17/2008 | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims |
| Health Center for Better Living, Inc. | 08/22/2008 | Florida District Office | New Drug/Labeling/False & Misleading Claims |
| SeniorLife Health Inc. | 08/21/2008 | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims |
| Daniel Chapter One Inc | 08/15/2008 | New England District Office | New Drug/Labeling/False & Misleading Claims |
| LifeGuard Health LLC | 07/29/2008 | Center for Food Safety and Applied Nutrition | Promotional Claims False & Misleading/New Drugs |
| Sharp Labs Inc | 07/09/2008 | Florida District Office | New Drug/Labeling/False & Misleading Claims |
| Tattva's Herbs, LLC | 07/09/2008 | Seattle District Office | Promotional Claims False & Misleading/Misbranded |
| Newman Inc., (dba Medi-Stat) | 06/24/2008 | New Orleans District Office | New Drug/Adulterated/Misbranded |
| NaturesAlternatives.com | 06/02/2008 | Los Angeles District Office | Promotional Claims/False & Misleading |
| Dherbs.com | 06/02/2008 | Los Angeles District Office | New Drug/Labeling/False Promotional Statements/Misbranded |
| Teeter Creek Herbs Company | 05/19/2008 | Kansas City District Office | Promotional Claims/False & Misleading/Misbranded |
| Gemtronics Inc | 04/17/2008 | Atlanta District Office | New Drug/Labeling/False & Misleading Claims |
| Hato Potrero Farm, Inc | 04/03/2008 | Florida District Office | Promotional Claims False & Misleading/New Drug/Misbranded |
| Laser Therapeutics | 03/21/2008 | New England District Office | Premarket Approval/Misbranded/Adulterated |
| Saferex Laboratories International Corporations | 03/04/2008 | Dallas District Office | New Drug/False Misleading/Labeling/ Misbranded |
| McKinnon, Blair | 03/04/2008 | Center for Drug Evaluation and Research | New Drug/False Misleading/Labeling/ Misbranded |
| NeumaLife | 03/04/2008 | Kansas City District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Health-science-report.com | 03/04/2008 | Seattle District Office | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded |
| IMULUX, LLC | 03/04/2008 | Dallas District Office | New Drug/False Misleading/Labeling/Misbranded |
| Aidance Skincare & Topical Solutions, LLC | 03/03/2008 | New England District Office | Drug Labeling/Promotional Claims/ Misbranded |
| Aviralex Int. | 03/03/2008 | San Francisco District Office | Drug Labeling/Promotional Claims/ Misbranded |
| Herbal Hope, Inc. | 02/25/2008 | Center for Food Safety and Applied Nutrition | New Drug/Labeling/False & Misleading Claims |
| International Pharmaceutical Corporation | 02/07/2008 | Center for Food Safety and Applied Nutrition | Drug Labeling/Promotional Claims/Misbranded |
| Nature's Way Products, Inc. | 01/25/2008 | Denver District Office | Dietary Supplements/Food/New Drug/ Adulterated/Misbranded |
| Bellevue Pharmacy Solution | 01/14/2008 | Kansas City District Office | Promotional Claims False & Misleading/Misbranded |
| Panorama Compounding Pharmacy | 01/07/2008 | Los Angeles District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Saint John's Medical Plaza Pharmacy | 01/07/2008 | Los Angeles District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Reed's Compounding Pharmacy | 01/07/2008 | Los Angeles District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Pharmacy Compounding Specialties | 01/07/2008 | Dallas District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Pacifica Pharmacy | 01/07/2008 | Los Angeles District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Murray Avenue Apothecary | 01/07/2008 | Philadelphia District Office | New Drug/False Misleading/Labeling/ Misbranded |
| Village Compounding Pharmacy | 01/07/2008 | Dallas District Office | New Drug/False Misleading/Labeling/ Misbranded |
2007
| Company Name | Letter Issue Date | Issuing Office | Subject |
|---|---|---|---|
| Heartland Products, Inc. | 10/22/2007 | Minneapolis District Office | Misbranded/Labeling/Unauthorized Health Claims |
| Health Freedom Nutrition, LLC | 10/16/2007 | San Francisco District Office | Misbranded/Labeling/ Unauthorized Health Claims |
| Health MarketPlace.com | 10/16/2007 | Baltimore District Office | Labeling Claims |
| Biotivia America | 10/15/2007 | Center for Food Safety and Applied Nutrition | Labeling Claims |
| Jen-On Herbal Science Intl | 10/12/2007 | Los Angeles District Office | Dietary Supplement/Labeling False and Misleading/Misbranded |
| Efficas | 09/28/2007 | Center for Food Safety and Applied Nutrition | Labeling & Promotional Claims |
| Alternative Health Approaches | 09/24/2007 | Los Angeles District Office | Drug Labeling/Promotional Claims/Misbranded |
| Procter and Gamble | 09/14/2007 | Cincinnati District Office | Labeling/OTC Drugs |
| F.H.G. Corporation | 08/22/2007 | Florida District Office | Promotional Claims/Misbranded |
| Vigor Nutriceutical Healthcare | 08/20/2007 | Minneapolis District Office | Misbranded/Labeling/Unauthorized Health Claims |
| Hain Celestial Group Inc. | 8/17/2007 | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| Swanson Health Products | 08/08/2007 | Minneapolis District Office | Dietary Supplements |
| Novis PR dba Kramer-Novis | 08/08/2007 | San Juan District Office | OTC Drug Products/Dietary Supplements/ Misbranded |
| Sunburst Biogranics | 08/07/2007 | New York District Office | Dietary Supplements |
| Schering-Plough Animal Health Corporation | 07/11/2007 | Center for Veterinary Medicine | Promotional Claims/False & Misleading/ Misbranded |
| Zeo Health Ltd. | 06/29/2007 | Center for Food Safety and Applied Nutrition | New Drugs/Claims |
| Merial Limited | 06/21/2007 | Center for Veterinary Medicine | Promotional Claims/New Drug/Misbranded |
| Heska Corporation | 06/05/2007 | Center for Veterinary Medicine | Promotional Claims False & Misleading/ Misbranded |
| TheraLife, Inc. | 06/01/2007 | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/New Drug/Misbranded |
| Panacea Products, LLC | 05/24/2007 | New Orleans District Office | New Drug/Labeling/False & Misleading Claims |
| Fusion Brands International SRL | 04/24/2007 | New Jersey District Office | Drug Products/Labeling |
| Langers Juice Co. | 04/17/2007 | Los Angeles District Office | Misbranded/Labeling/Unauthorized Health Claims |
| Redux Beverages, LLC | 04/04/2007 | Los Angeles District Office | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded |
| Freedom Plus Corporation | 03/29/2007 | San Francisco District Office | Dietary Supplement/Adulterated |
| Beehive Botanicals, Inc. | 03/02/2007 | Minneapolis District Office | Dietary Supplements |
| BioForm Medical, Inc. | 02/17/2007 | Minneapolis District Office | Labeling Drug Claims |
| Alternative Health & Herbs Remedies | 01/16/2007 | Seattle District Office | New 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.
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