FDA Warning Letters about Products (2016)
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.
- Aurora Health and Nutrition / Robert G. Thompson (12/1/16): 5-HTP, Alpha Lipoic Acid, the Argentyn 23 product line, Artecin 90 Vegetarian Capsules, ChromeMate GTF 600, Cold Sore Rescue, Curcumin, Myomin, Ozonated Olive Oil
- Hsu’s Ginseng Enterprises, Inc./ Paul S. Hsu (7/22/16): ALASKA Fish Oil, Cultivated Pearl Medium Deluxe Pack, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Ocean Luck Premium Abalone, Spirulina Plus B6 & B12, White Bird’s Nest, American Ginseng, marketed as Cultivated Pearl Medium Deluxe Pack
- Nutri-Dyn Midwest, Inc. / David S. Peterson (1/15/16): Cardioauxin BP, Zinc Lozenge, Oliver, Pau D’Arco, Petadolex, Chondro Jointaide, Dynagesic, SAMe-200, and Gugulipid. In addition, FDA reviewed your product labeling for your CaridoAuxin BP, Coenzyyme Q10, OmegaGenics Mega 10, ArginCor™, NutrihCG, NutrihCG Reset, Nutri DMSA, Metal Detox, D3 5000, Cardioauxin, Red Yeast Extract Extra Strength
- Side Effect Solutions Corporation d/b/a/Nobetes Corporation / Mrtin Silver (9/15/16): Nobetes
- Thermogram Assessment Services / Edward B. Jay (11/10/16): TAS Thermal Imaging System
This page was revised on December 4, 2018.