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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
03/01/2021 Ageless Global, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/18/2021 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
01/22/2021 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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