FDA Warning Letters about Products (2017)
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.
- BioStar Technology International, LLC / Ulysses Angulo (4/17/17): Angiostop, Asparagus Extract, Ashwagandha, Desbio Venus Fly Trap, Liver Chi, Kidney Chi, OliveLeaf Qi, Revivn, Safed Musli, Weight Less No 4
- Dae Young Foods Company, Ltd. / JongWoo Kim (11/20/17): Smoker's Appetite Relief
- Deserving Health International Corp / Bernard Amani (12/18/2017): Symbio Muc Eye Drops 5X homeopathic drug product
- Healing Within Products & Services, Inc. / Stan Weinberger (4/17/17): Astragalus Glycerite, Black Salve, Healthy Prostrate & Ovary, Hepato-C, NanoSilver, Normalose, Original Herbal Tea Remedy, ProBoost Thymic Protein A, Siberian Chaga Mushroom Extract
- HomeoCare Laboratories / Edith Scheiner (9/7/17): HBP Relief, Cholestop, IBS Relief
- Homeolab USA Inc. / Michele Boisvert (9/19/13): Homeopathic product: Kids Relief Earache
- Humaworm / Reba G. Bailey (2/8/17): Humaworm Formula, Fast Help Formula, Liver & Gallbladder Cleanse & Restore, Lung Cleanser, Natural Anti-Biotic, Natural Anti-Viral, Herpes Cleansing Formula, Lyme's & Syphillis Cleansing Formula, Natural Pain Killer, Hu-Mana-Tea!, Candida Yeast & Fungi Cleanse, Colon Cleanse, Lung Cleanse, RG's Medicated Skin Cream
- LifeVantage Corporation / Darren Jensen (4/17/17): Protandim NRF2 Synergizer
- Mannatech Inc. / Alfredo Bala (11/14/17): Efficacy claims for Bounceback and nutrient content claims for several other products.
- Nature's Treasures / Raya Shanazarian (4/17/17): KR22 Oxicell, Dysbiocide, Colostrum LD®, FC-Cidal, Diabend, Matcha Tea and NeurO2; and a thermographic camera
- Nova Homeopathic Therapeutics / Dr. Charles L. Bernaert (9/1/17): Depression Complex, Circulation Complex, and Liver Complex
- Raritan Pharmaceuticals, Inc. / Dr. Vin K. Nayak (6/20/17): Homeopathic Infant Teething Tablets.
- Sunstone, Inc. / Einar Bjarnson (4/17/17): Essiac Tea, Virxcan-X Salve, Chelated Boron, Candida-X Tablets, Circulatory Detox & Support Syrup, Colloidal Silver Spray, Fermented Yeast Culture, General Body Detox & Support Tincture, Koffaway Glycerite, Lobelia Tincture, Plague Buster Syrup, Virxcan-X Tablets
- U.S. Stem Cell / Kristin Comella (8/24/17): Stem cell products
This page was revised on January 25, 2019.