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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
10/28/2022 Latin Foods Market Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/28/2022 Walmart Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
05/04/2022 BioMD Plus LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 M Six Labs, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 Kingdom Harvest Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 Delta 8 Hemp Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022 ATLRx, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
04/20/2022 C R Supplements, LLC Office of Human and Animal Food Operations – West Division 6 Unapproved New Drugs/Misbranded
04/19/2022 Kleenhanz, LLC Center for Drug Evaluation and Research | CDER Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
04/13/2022 Elements Brands Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Skin Authority, L.L.C. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 AMBI Enterprises LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Genomma Lab USA, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 M & M Beauty and Wellness, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 True Earth Health Products, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 SkinPro Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Skin PS Brands Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Clinical Formula LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Dr. Thomas Balshi/Intilight Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Ultimark Products Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/13/2022 Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
04/06/2022 Sensory Cloud, Inc Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/05/2022 CofixRx, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Greenway Herbal Products LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Cureganics Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Functional Remedies, LLC D/B/A Synchronicity Hemp Oil Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 UPSY LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Heaven’s Organic LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 CBD Social Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/28/2022 Nature's Highway Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/25/2022 Iodine Products Inc Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/24/2022 Applied Biological Laboratories Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
03/15/2022 Honey Feast, Inc. Office of Human and Animal Food Operations East Division IV New Drug/Misbranded
03/15/2022 Iotech International, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/10/2022 Soda Pharm Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/07/2022 Viraldine, LLC Center for Drug Evaluation and Research | CDER Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
02/23/2022 Princess Lifestyles, LLC Office of Human and Animal Food Operations –West Division 5 Unapproved New Drugs/Misbranded
02/17/2022 Vital Health & Wellness Office of Human and Animal Foods Operations-East V New Drug/Misbranded
02/11/2022 Rena's Organic Office of Human and Animal Foods Division 4 East Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
02/09/2022 Bea Lydecker’s Naturals, Inc. Division of Human and Animal Food Operations West VI Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
02/04/2022 Crystal Clear Supplements Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
02/03/2022 Pharmacy2Home/LandiCom Holding LTD Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
02/01/2022 New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
01/19/2022 Glenn Burkett Naples Corporation Office of Human and Animal Food Operations East Division IV Unapproved New Drugs/Misbranded
01/03/2022 Amcyte Pharma, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product 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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