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.
Previous Years: 2019 | 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007
| Letter Issue Date | Company Name | Issuing Office | Subject | |
|---|---|---|---|---|
| 06/26/2020 | SuperHealthGuard and Loyal Great International Ltd. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/26/2020 | Nuance Health, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/25/2020 | Curativa Bay Corporation | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/19/2020 | North Isle Wellness Center | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/18/2020 | Only Natural, Inc. dba Bio Nutrition, Inc. | Division of Human and Animal Food Operations East I | Unapproved New Drugs/Misbranded | |
| 06/18/2020 | Project 1600 Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/17/2020 | KBMO Diagnostics, LLC | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 | |
| 06/11/2020 | Hevert Pharmaceuticals LLC USA | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |
| 06/15/2020 | antibodiescheck.com | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/15/2020 | Sonrisa Family Dental dba www.mycovidtest19.com | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/11/2020 | World Health Advanced Technologies Ltd | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |
| 06/11/2020 | Medinatura Inc | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |
| 06/11/2020 | 8046255 Canada Inc. DBA Viatrexx | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs | |
| 06/10/2020 | ww.outoftheboxremedies.com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/10/2020 | Medakit Ltd | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/08/2020 | organic-beauty-recipes.com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/04/2020 | EUCYT Laboratories LLC | Office of Biological Products Operations - Division II | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/01/2020 | Dr. Sherrill Sellman | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 06/01/2020 | Morningstar Minerals LLC | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded | |
| 05/28/2020 | StayWell Copper Products | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/28/2020 | Quadrant Sales & Marketing, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/26/2020 | CBD Gaze | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/26/2020 | Alternavita | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/26/2020 | Musthavemom.com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/26/2020 | Careful Cents, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/21/2020 | NutraCap Labs LLC | Division of Human and Animal Food Operations East III | CGMP/Dietary Supplement/Adulterated | |
| 05/21/2020 | North Coast Biologics | Center for Biologics Evaluation and Research (CBER) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/21/2020 | Apollo Holding LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/19/2020 | Life Unlearned, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/19/2020 | SpiceTac | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/15/2020 | Natural Solutions Foundation | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/15/2020 | LifeHealth Science | Division of Human and Animal Food Operations East V | Unapproved New Drugs/Misbranded | |
| 05/15/2020 | The Golden Road Kratom | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/15/2020 | Noetic Nutraceuticals | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/14/2020 | benjaminmcevoy.com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/14/2020 | White Eagle Native Herbs | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/11/2020 | Center for New Medicine/Perfectly Healthy by Connealy MD | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/11/2020 | Fusion Health and Vitality LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/08/2020 | Seanjari Preeti Womb Healing, L.L.C. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/08/2020 | Plum Dragon Herbs, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/07/2020 | New Spirit Naturals Inc. | Division of Human and Animal Food Operations West V | New Drug/Misbranded | |
| 05/07/2020 | Chronic Lyme Treatments | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/07/2020 | WashingtonsLastFrontier.Com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/07/2020 | AgroTerra, Ltd. dba Patriot Hemp Company | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/07/2020 | Sanit Technologies LLC dba Durisan | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/06/2020 | Alive By Nature, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/06/2020 | GlutaGenic | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/04/2020 | Dr. Dhole's Sushanti Homeopathy Clinic | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 05/04/2020 | Honey Colony LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 04/28/2020 | The Dragontree Apothecary LLC | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | |
| 04/27/2020 | Hopewell Essential Oils | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 04/27/2020 | Santiste Labs LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) | |
| 04/23/2020 | Prefense LLC | Center for Drug Evaluation and Research | CDER | Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) and Other Diseases | |
| 04/23/2020 | BIOTA Biosciences LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |
| 04/21/2020 | DrJockers.com, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 04/21/2020 | Copper Touch, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |
| 04/20/2020 | Humaworm | Office of Human and Animal Foods Operations East 5 | Unapproved New Drugs/Misbranded | |
| 04/20/2020 | Homero Corp DBA Natures CBD Oil Distribution | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | |
| 04/16/2020 | Nova Botanix LTD DBA CanaBD | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/16/2020 | Global Vitality, Inc. dba Enzyme Process International | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded | |
| 04/16/2020 | Lose Fat Gain Life M&B | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded | |
| 04/15/2020 | The Art Of Cure | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/14/2020 | Earth Angel Oils | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/13/2020 | The GBS dba Alpha Arogya India Pvt Ltd | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/13/2020 | Gaia Arise Farms Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/13/2020 | JusByJulie.Com LLC | Office of Human and Animal Food Operations East Division 1 | New Drug/Misbranded | |
| 04/10/2020 | Herbs of Kedem | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/09/2020 | BIOTA Biosciences LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |
| 04/09/2020 | Earthley Wellness dba Modern Alternative Mama LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/09/2020 | Free Speech Systems LLC d.b.a. Infowars.com | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/08/2020 | NRP Organics Ltd | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/08/2020 | Genesis 2 Church | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/07/2020 | Savvy Holistic Health dba Holistic Healthy Pet | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/07/2020 | CBD Online Store | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/06/2020 | Alternative Health Experts LLC DBA Immunization Alternatives | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/06/2020 | Indigo Naturals | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/06/2020 | Ananda, LLC DBA Ananda Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/06/2020 | Cathay Natural, LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/06/2020 | Native Roots Hemp | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/01/2020 | Gaia's Whole Healing Essentials, LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/01/2020 | Homeomart Indibuy | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 04/01/2020 | Health Mastery Systems DBA Pure Plant Essentials | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/31/2020 | KetoKerri LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Labeling/Misbranded | |
| 03/31/2020 | NeuroXPF | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/30/2020 | Bioactive C60/FullerLifeC60 LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/30/2020 | Halosense Inc. | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/30/2020 | JRB Enterprise Group Inc. DBA Anti Aging Bed | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/27/2020 |
|
Office of Human and Animal Foods Division 5 West | New Drug/Misbranded | |
| 03/26/2020 | Corona-cure.com | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/26/2020 | Carahealth | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/20/2020 | Images Unlimited Products, d.b.a. Cellect Products & Oglethorpe, Ltd. | Division of Human and Animal Food Operations East I | Unapproved New Drugs/Misbranded | |
| 03/20/2020 | Bulletproof 360 Inc | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded | |
| 03/06/2020 | Quinessence Aromatherapy LTD | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | GuruNanda LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | Colloidal Vitality LLC/Vital Silver | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | Xephyr, LLC dba N-Ergetics | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | Vivify Holistic Clinic | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | The Jim Bakker Show | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 03/06/2020 | Herbal Amy Inc | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |
| 02/21/2020 | Warner Herb Co. | Office of Human and Animal Foods Operations-East | Unapproved New Drugs/Misbranded | |
| 02/18/2020 | R-Garden LLC | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded | |
| 02/12/2020 | Nature Essence Small Molecule Co., LTD | Division of Human and Animal Food Operations East V | Cosmetics/Adulterated/Misbranded | |
| 01/17/2020 | GOJO Industries Inc | Division of Pharmaceutical Quality Operations III | Unapproved New Drugs/Misbranded | |
| 01/13/2020 | Wave Miami LLC | Division of Pharmaceutical Quality Operations I | Unapproved New Drugs/Misbranded |
*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.