For Consumers

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 DateCompany NameIssuing OfficeSubject
Unproven Alzheimer's Disease Products - 17 letters
03/11/2019Nutra PharmaCenter for Drug Evaluation and ResearchUnapproved New Drugs/Misbranded
03/08/2019Aidacess.orgCenter for Drug Evaluation and ResearchUnapproved New Drugs/Misbranded
03/08/2019RablonCenter for Drug Evaluation and ResearchUnapproved New Drugs/Misbranded
03/05/2019Hanna's Herb ShopDenver District OfficeNew Drug/Misbranded
02/05/2019Pure Nootropics, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019 TEK NaturalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Nutrition Coalition IncCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Blue Ridge Silver Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Sovereign Laboratories, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019DK Vitamins Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Peak Nootropics LLC (aka Advanced Nootropics) Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Gold Crown Natural Products Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Emmbros Overseas Lifestyle PVT LTD.Center for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Earth Turns, LLCCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
02/05/2019Capris Associates Inc. / BR NaturalsCenter for Food Safety and Applied NutritionNew Drug/Labeling/Misbranded
01/31/2019Green Water, LLCDenver District OfficeUnapproved New Drugs/Misbranded
01/30/2019Phi SciencesDenver District OfficeUnapproved 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.

Page Last Updated: 03/20/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English