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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.

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Letter Issue Date Company Name Issuing Office Subject
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 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)
03/26/2020 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 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.