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: 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007

Letter Issue DateCompany NameIssuing OfficeSubject
07/11/2017Black Seed Herb, Inc.New York District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
07/06/2017Irie Star LLCKansas City District OfficeNew Drug/Labeling/Misbranded
06/30/2017Nature's Health Company, LLCCincinnati District OfficeNew Drug/Misbranded
06/27/2017New Capstone, IncLos Angeles District OfficeNew Drug/Misbranded
06/15/2017Soapwalla Inc.Center for Food Safety and Applied NutritionNew Drug/Labeling
06/08/2017Belmora LLCBaltimore District OfficeUnapproved New Drugs/Misbranded
06/05/2017Andropharm, LLCDallas District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
06/05/2017Hardcore FormulationsDallas District OfficeNew Drugs/Dietary Supplements/Food Labeling/Misbranded
06/02/2017Perfectly PoshDenver District OfficeNew Drug/Labeling/Misbranded
05/26/2017Star Health & Beauty LLCAtlanta District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
05/25/2017Big Dan's Fitness / Nutrition, LLCLos Angeles District OfficeInternet Marketing of Unapproved and Misbranded Drugs
05/25/2017Herbal Doctor RemediesLos Angeles District OfficeUnapproved New Drugs/Misbranded
05/25/2017Life Rising CorporationChicago District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/25/2017The Herbalist, Inc.Seattle District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/22/2017Bio TE MedicalDallas District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/12/2017VitaPurity CorporationSeattle District OfficeAdulterated Dietary Supplements, Unapproved New and Misbranded Drugs
05/12/2017Formulife, Inc.Dallas District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/01/2017Nature's Vision, IncDetroit District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
05/01/2017Thor Inc.Denver District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
04/20/2017Montana Emu Ranch Company IncSeattle District OfficeUnapproved New Animal Drug/Adulterated/Misbranded/Misleading
04/19/2017Tobin's Royal Stag, Inc. dba Tobin Farms Velvet AntlerNew England District OfficeUnapproved New Drugs/Misbranded
04/17/2017Aie Pharmaceuticals IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
04/17/2017Amazing Sour Sop, Inc.Florida District OfficeUnapproved New Drugs/Misbranded
04/17/2017BioStar Technology International, LLCLos Angeles District OfficeUnapproved New Drugs/Misbranded
04/17/2017DoctorVicks.comNew York District OfficeUnapproved New Drugs/Misbranded
04/17/2017Everything HerbsAtlanta District OfficeUnapproved New Drugs/Misbranded
04/17/2017Hawk Dok Natural Salve, LLCLos Angeles District OfficeUnapproved New Drugs/Misbranded
04/17/2017Healing Within Products & Services, IncSan Francisco District OfficeUnapproved New Drugs/Misbranded
04/17/2017Lifevantage CorpDenver District OfficeUnapproved New Drugs/Misbranded
04/17/2017Nature's TreasuresLos Angeles District OfficeUnapproved New Drugs/Misbranded
04/17/2017Oxygen Health Systems, LLCChicago District OfficeUnapproved New Drugs/Misbranded
04/17/2017Sunstone, Inc.Denver District OfficeUnapproved New Drugs/Misbranded
04/17/2017The Vitamin C FoundationChicago District OfficeUnapproved New Drugs/Misbranded
04/17/2017Vibrant Health Store, LLCSeattle District OfficeUnapproved New Drugs/Misbranded
04/17/2017Caudill Seed & Warehouse IncCincinnati District OfficeUnapproved New Drugs/Misbranded
04/14/2017Genetic Edge Compounds LLCDallas District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
04/05/2017Jus Bar LLCNew York District OfficeUnapproved New Drugs/Misbranded
03/24/2017Sanapac Co., Inc.Philadelphia District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
03/20/2017Vacunda & DesignSan Juan District OfficeNew Drug/Misbranded
03/16/2017DSE Healthcare Solutions, LLCNew Jersey District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
03/02/2017Cape Fear NaturalsAtlanta District OfficeCGMP/Finished Pharmaceuticals/Adulterated
02/24/2017Nutrishop dba Natural Generation NutritionNew Jersey District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
02/17/2017Aegeia Skin Care, LLCDallas District OfficeNew Drugs/Cosmetics Labeling and Marketing with Drug Claims
02/08/2017HumawormNew Orleans District OfficeUnapproved New Drugs/Misbranded
02/01/2017Life Extension Foundation Buyers Club, Inc.Florida District OfficeNew Drug/Labeling/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: 07/18/2017
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