For Consumers

2017 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.

Letter Issue DateCompany NameIssuing OfficeSubject
12/28/2017Investra-24hsCenter for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/Misbranded
12/19/2017Maine Natural Health, Inc.New York District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
12/14/2017BrainAlert, LLCSeattle District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
12/14/2017Eden’s Answers Inc. and Sprigs Life Inc.Cincinnati District OfficeUnapproved New Drugs/Misbranded
12/13/2017Dynamic Technical FormulationsAtlanta District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
12/13/2017GnuPharma Corp.Dallas District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
12/11/2017Arco Globus Trading LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/Misbranded
11/30/2017TruVision Health LLCDenver District OfficeCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
11/30/2017Wellness Resources, Inc.Minneapolis District OfficeNew Drug/Labeling/Misbranded
10/31/2017Green Roads of Florida LLCSan Juan District OfficeNew Drug/Misbranded/Cannabidiol(CBD) products
10/31/2017Herbal AlchemistLos Angeles District OfficeNew Drug/Misbranded/Cannabidiol(CBD) products
10/31/2017That's NaturalLos Angeles District OfficeNew Drug/Misbranded/Cannabidiol(CBD) products
10/31/2017Stanley Brothers Social Enterprises, LLCLos Angeles District OfficeNew Drug/Misbranded/Cannabidiol(CBD) products
10/23/2017Panther Sports NutritionNew Jersey District OfficeUnapproved New Drugs/Misbranded
10/23/2017Ironmag LabsLos Angeles District OfficeUnapproved New Drugs/Misbranded
10/23/2017Infantry Labs LLCDetroit District OfficeUnapproved New Drugs/Misbranded
10/16/2017Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
10/06/2017Nexagen, LLCAtlanta District OfficeCGMP/Dietary Supplement/Adulterated
09/28/2017Total Body NutritionNew York District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
09/15/2017Grandma's HerbsDenver District OfficeNew Drug/Misbranded
09/07/2017Newton Everett/WR Group Inc.Denver District OfficeNew Drug/Misbranded
09/01/2017Nova Homeopathic Therapeutics IncLos Angeles District OfficeCGMP/Finished Pharmaceuticals/Adulterated
09/01/2017Nd Labs, Inc.New York District OfficeMedical Foods/Unapproved New Drug/Misbranded
08/30/2017MusclMasster, LLCDenver District OfficeUnapproved New Drugs/Misbranded
08/25/2017Mega Pro InternationalDenver District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
08/16/2017Total Nutrition IncNew York District OfficeCGMP/Dietary Supplement/Adulterated/Misbranded
08/15/2017Years to Your Health, Inc.Dallas District OfficeUnapproved New Drugs/Misbranded
08/11/2017Moon Valley Natural Products LLCSeattle District OfficeNew Drug/Labeling/Misbranded
08/10/2017Skin 2 SpiritBaltimore District OfficeNew Drug/Labeling/Misbranded
07/26/2017Madison One Acme IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
07/25/2017AbsonutrixAtlanta District OfficeNew Drug/Labeling/False & Misleading Claims
07/21/2017AmafruitsChicago District OfficeNew Drug/Misbranded
07/19/2017Be Natural OrganicsChicago District OfficeNew Drug/Labeling/Misbranded
07/18/2017Terra Biological LLCCenter for Food Safety and Applied NutritionUnapproved New Drugs/Misbranded
07/18/2017Vedame Oils LLC dba UMA OilsLos Angeles District OfficeUnapproved New Drugs/Misbranded
07/11/2017Black Seed Herb, Inc.New York District OfficeCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
07/06/2017Professional Botanicals, Inc.Denver District OfficeDietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded
07/06/2017APS BioGroup, IncLos Angeles District OfficeUnapproved New Drugs/Misbranded
07/06/2017Irie Star LLCKansas City District OfficeNew Drug/Labeling/Misbranded
06/30/2017Nature's Health Company, LLCCincinnati District OfficeNew Drug/Misbranded
06/29/2017God Quest, Inc. d/b/a Creation TodaySan Juan 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
05/03/2017MS BionicLos Angeles District OfficeUnapproved New Drugs/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: 11/28/2018
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