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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.

Previous Years: 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007

Letter Issue Date Company Name Issuing Office Subject
Unproven Alzheimer's Disease Products - 17 letters
09/18/2019 Alternative Laboratories Office of Human and Animal Food Operations East Division IV Dietary Supplement/Adulterated
08/20/2019 Let's Talk Health, Inc. Division of Human and Animal Food Operations West V Unapproved New Drugs/Misbranded
07/23/2019 Curaleaf, Inc Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
06/25/2019 Cali Botanicals, LLC Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
06/11/2019 Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc. Division of Human and Animal Food Operations East I CGMP/Dietary Supplement/Adulterated/Misbranded
06/06/2019 PRL Inc Division of Human and Animal Food Operations East V CGMP/Dietary Supplement/Adulterated/Misbranded
05/16/2019 KratomNC Center for Drug Evaluation and Research Unapproved New Drug/Misbranded
05/15/2019 ActiveHerb Technology, Inc Division of Pharmaceutical Quality Operations IV Unapproved New Drugs/Misbranded
05/07/2019 AMMD Labs, LLC Division of Pharmaceutical Quality Operations II Unapproved Drugs/Misbranded
05/02/2019 Kadesh International  Division of Pharmaceutical Quality Operations IV Unapproved Animal Drugs/Misbranded Human Drugs
04/29/2019 Golean Detox US Division of Pharmaceutical Quality Operations II Unapproved New Drugs/Misbranded
04/23/2019 Newton Laboratories Inc DBA Newton Homeopathics Division of Pharmaceutical Quality Operations II Unapproved New Drugs/Misbranded
04/11/2019 Total Body Nutrition Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 Down to Earth Solutions, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 NeuroScience Solutions, Inc. dba NeuroScience Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded
04/10/2019 eflow Nutrition LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 Hi Tech Pharmaceuticals Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 IQ Formulations, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded
04/10/2019 Line One Nutrition, Inc Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 Iron Brothers Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 Forbiddenlabz Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated
04/10/2019 Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded
04/10/2019 Atomixx Center for Food Safety and Applied Nutrition Dietary Supplement/Misbranded
04/10/2019 Empire Distributors, Inc. Division of Pharmaceutical Quality Operations III Inactive Ingredient, Misbranding
04/03/2019 Texas Aloe Corporation, Inc. Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded
03/28/2019 Nutra Pure LLC Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded
03/28/2019 Advanced Spine and Pain, LLC (d/b/a Relievus) Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded
03/28/2019 PotNetwork Holdings, Inc. Center for Food Safety and Applied Nutrition New Drug/Misbranded
03/27/2019 Azmedicinalshop.com Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/27/2019 Thedonrx.net Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/21/2019 B. Jain Pharmaceuticals Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated
03/20/2019 King Bio Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated
03/20/2019 Red Mountain Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated
03/11/2019 Nutra Pharma Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded
03/08/2019 Aidaccess.org Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded
03/08/2019 Rablon  Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded
03/05/2019 Hanna's Herb Shop Denver District Office New Drug/Misbranded
02/05/2019 Pure Nootropics, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 TEK Naturals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 John Gray's Mars Venus LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Nutrition Coalition Inc Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Blue Ridge Silver Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Sovereign Laboratories, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 DK Vitamins Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Peak Nootropics LLC (aka Advanced Nootropics) Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Gold Crown Natural Products Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Emmbros Overseas Lifestyle PVT LTD. Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Earth Turns, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
02/05/2019 Capris Associates Inc./BR Naturals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded
01/31/2019 Green Water, LLC Denver District Office Unapproved New Drugs/Misbranded
01/30/2019 Phi Sciences Denver District Office 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.