FDA Warning Letters about Products (2012)
The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.
Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped. Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.
- A Nelson Co. Ltd. / Najib Fayad (7/26/12): Homeopathic products: Arnica, Arnileve Amerida Cream
- ABCO Laboratories Inc / Allen Baron (6/19/12): Homeopathic products: IBU-RELIEF 12, Idebenone, Sexual Virility Max
- Advanced Nutritional Technology / Grace S. Chang (10/16/12): Ultra Diabless, Nutr-E-Sol, Formula 3/6/9, Nutr-Epo, Super EPA 2000, Super G, Coenzyme Q10, Crangel
- AMARC Enterprises / Albert Sanchez (12/11/12): Poly MVA
- BioAnue Laboratories / Gloria Raber (2/9/12): Bovine Cartilage, TumorX BioEnerGenics Co-Enzyme -Q10, TumorX Cardio Clean, Diabetic Mender, TumorX Formula CX, and Stroke Mender
- William C. Domb, DMD (10/25/12): Ozone generating system
- From Fatigue to Fantastic / Jacob Teitelbaum, M.D. (April 18, 2012): Corvalen (D-Ribose), Coenzyme Q10, Jigsaw Magnesium w/ SRT, "BMR Complex (Thyroid Glandular), Energy Revitalization System, Acetyl-L-Carnitine, Chol-less, Thymic Protein, Alpha Lipoic acid, Black Cohosh, and Eskimo 3 Fish Oil.
- Grato, Inc / Jesse E. Rettig (7/30/12): Homeopathic products: Vital Male Sexual Energy, Vital HGH Skin Hair Nails, Vital HGH Immune Booster, Vital HGH, TinnitusDX, Fibro Relief, AR Arthritis.
- Health Technology / Jack Lee Davis (11/15/12): Professional Choice Pycnogenol, Natural Solutions Memory, Super-Imuno Plus
- IntelliCell Biosciences / Dr. Steven Victor (3/13/12): Adipose-derives stem cells
- Myotronics-Noromed, Inc. / Fray Adib (4/5/12): K7 Evaluation System, J5 Myo-monitor, BNS-40 Bilateral Neuro Stimulator.
- Quincy Bioscience Manufacturing Inc. / Mark Y. Underwood (10/16/12): Prevagen
- Schwabe North America / Michael Devereaux (2/15/12): Umcka® ColdCare Original Drops, ColdCare Alcohol Free Drops, ColdCare Syrup (Mint-Menthol), ColdCare Syrup (Cherry), ColdCare Sugar-Free Syrup (Grape), ColdCare Soothing Hot Drink (Lemon), ColdCare Chewable (Mint-Menthol), ColdCare Chewable (Cherry), ColdCare FastActives™ Powder Packets (Cherry), ColdCare Children's Syrup (Cherry), ColdCare Children's FastActives™ Powder Packets (Cherry), Cold+Flu Syrup (Berry), Cold+Flu Syrup (Orange), Cold+Flu Chewable (Berry), Cold+Flu Chewable (Orange), and Cold+Flu FastActives™ Powder Packets (Berry)
- USP Labs (4/24/12): Oxy Elite Pro, Jack3D
- Women's Health Institute of Texas / Andrew Jones, MD (11/5/12): Digest + SEB, Iodine Plus 2, and D5000 (Vitamin D)
This page was revised on August 15, 2017.