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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 Firm Name Issuing Office Subject
07/20/2021 Jordan’s Crossing Herbal Connections Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/07/2021 Halodine, LLC Center for Drug Evaluation and Research Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
07/01/2021 Phoenix Nutritionals, Inc. Office of Human and Animal Food Operations-West Division 5 New Drug/Misbranded
07/01/2021 Biomedical Research Laboratories, LLC Office of Human and Animal Food Operations –West Division 5 New Drug/Misbranded
06/23/2021 Great Healthworks, Inc. Office of Human and Animal Food Operations, Division IV East Unapproved New Drugs/Misbranded
06/22/2021 Pacific Center of Health/Pacific Center of Health & Acupuncture Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/10/2021 Natural Hope Herbals, LLC Division of Human and Animal Food Operations East II New Drug/Misbranded
06/10/2021 Innova Medical Group, Inc. Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/07/2021 Flora Inc Division of Human and Animal Food Operations West VI New Drug/Misbranded
05/27/2021 Fresh Nutrition Inc Office of Human and Animal Food Operations –West Division 5 Unapproved New Drugs/Misbranded
05/27/2021 OCLO LLC/OCLO Nanotechnology Science Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/26/2021 JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health Office of Human and Animal Food Operations- West Division 5 New Drug/Misbranded
05/24/2021 Beauty & Spa Concepts, DBA Beenefits Center for Food Safety and Applied Nutrition Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/24/2021 Everything Health LLC Center for Food Safety and Applied Nutrition Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/20/2021 NS Products, Inc. Center for Food Safety and Applied Nutrition New Drug/Misbranded
05/20/2021 Fertility Nutraceuticals LLC Center for Food Safety and Applied Nutrition New Drug/Misbranded
05/20/2021 EU Natural Inc. Center for Food Safety and Applied Nutrition New Drug/Misbranded
05/20/2021 LeRoche Benicoeur dba ConceiveEasy Center for Food Safety and Applied Nutrition New Drug/Misbranded
05/20/2021 Sal Nature LLC/FertilHerb Center for Food Safety and Applied Nutrition New Drug/Misbranded
05/19/2021 BGP, LLC Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/18/2021 Sage Moon Apothecary LLC Division of Human and Animal Food Operations East I New Drug/Misbranded
05/10/2021 Great Lakes Gelatin Company Office of Human and Animal Food Operations East-VI New Drug/Misbranded
05/06/2021 Disinfect & Shield Center for Drug Evaluation and Research Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
05/06/2021 Covalon Technologies Inc. Center for Drug Evaluation and Research Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
05/04/2021 Baltimore Beauty Security Square Mall Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/29/2021 Crown Wellness, Inc Center for Food Safety and Applied Nutrition New Drug/Misbranded
04/27/2021 NeuroHydrate LLC Office of Human and Animal Food Operations East – Division 1 New Drug/Misbranded
04/21/2021 DRF LLC Office of Human and Animal Foods Operations- West Division New Drug/Misbranded
04/21/2021 North American Hirudin Biotech Products Inc. Office of Regulatory Affairs New Drug/Misbranded
04/15/2021 Molecular BioLife International, Inc. Office of Human and Animal Foods West Division II New Drug/Misbranded
04/13/2021 Trinity Natural Health & Pain Management, Inc. Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/13/2021 Orphic Nutrition Office of Human and Animal Food Operations –West Division 5 New Drug/Misbranded
04/13/2021 Anytime COVID Test LLC Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/08/2021 Groupe Cyrenne Inc. dba HomeoAnimal Center for Veterinary Medicine Unapproved New Animal Drug Products
04/07/2021 Allure Imports Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/07/2021 About Mineral Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/07/2021 Unived Inc Office of Human and Animal Food Operations- West Division 5 New Drug/Misbranded
04/06/2021 Sethi Laboratories Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/01/2021 Natural Adventure, LLC Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/30/2021 Immune & Genetics Protocols, LLC Office of Human and Animal Food Operations, East Division IV New Drug/Misbranded
03/19/2021 Lipotriad LLC Division of Human and Animal Food Operations East II New Drug/Misbranded
03/25/2021 Ikcon Investments, Inc dba Ikcon Medical Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/24/2021 Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/18/2021 Block Scientific Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/16/2021 Anna Health, LLC Division of Human and Animal Food Operations East IV New Drug/Misbranded
03/16/2021 Duoc Thao Tre Xanh, LLC Division of Human and Animal Food Operations East IV New Drug/Misbranded
03/15/2021 BioLyte Laboratories, LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
03/15/2021 Honest Globe, Inc. Division of Pharmaceutical Quality Operations III CGMP/Finished Pharmaceuticals/Adulterated
03/12/2021 Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/05/2021 CAMA Wellness Center/IodoRios Company, LLC Center for Drug Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Shenzhen Sunell Technology Corporation Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Workswell Group s.r.o. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Westminster International Ltd Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 CreativeStar Solutions Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Thermavis Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Opgal Optronic Industries Ltd. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Thermoteknix System Limited Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Omnisense Systems Pte Ltd. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Omega Engineering Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Dubak Electrical Group Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 EnMed MicroAnalytics, Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/04/2021 Orvic dba Webstore-USA Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/01/2021 Cannafyl Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
03/01/2021 Ageless Global, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/26/2021 Orvic dba Webstore-USA Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/19/2021 Richardson Nutritional Center, LLC/Nutriseeds, Inc. Office of Human and Animal Food Operations-West Division 5 New Drug/Misbranded
02/18/2021 Mercola.com, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/18/2021 B4B Corp. Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/18/2021 SafaLab, Inc. Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/18/2021 Blossom Nature, LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 ProHealth Inc. Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Dr. Garber’s Natural Solutions Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 FDC Nutrition Inc. Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 SANA Group LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Lifted Naturals Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Enlifta, LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Wholesome Wellness Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Mountain Peak Nutritionals Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/18/2021 Native Remedies dba Silver Star Brands Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
02/16/2021 Evolved Ayurvedic Discoveries, Inc./BioCBDPlus Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
02/16/2021 Dr. Paul's Lab Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/02/2021 Clarke Pharmaceutical Manufacturing, Inc. Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded
01/25/2021 PYRLess Group, LLC dba Dr. Fitt Center for Food Safety and Applied Nutrition Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/25/2021 EnMed MicroAnalytics, Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/22/2021 American Global Health Group, LLC Division of Human and Animal Food Operations West VI New Drug/Misbranded
01/14/2021 Sage Moon Apothecary LLC Division of Human and Animal Food Operations East I New Drug/Misbranded
01/12/2021 Allimax Us Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/12/2021 AusarHerbs Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
01/06/2021 Entia Biosciences, Inc Division of Human and Animal Food Operations West VI New Drug/Misbranded
01/04/2021 Coco's Holistic Specialties & Apothecary Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
*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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