FDA Warning Letters about Products (2007)
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.
- Avazzia, Inc / Timothy B. Smith (6/20/07): Tennant Biomodulator™, Body-Stim™ Device, Best-Pro 1™ Biofeedback Device, Best-RSI™ Device, Med Best and Med Sport Device.
- Cephalon, Inc. / Frank Baldino, Jr (2/27/07): Provigil
- Eidam Diagnostics Corporation / Bernard Armani (7/26/07): CRT 2000 Thermographic System
- Lorraine Day, MD (5/9/07): BetaBeet
- Martin Nutraceuticals (aka MNI Nutraceuticals / Anthony Martin (9/10/07): Arthrizyme, Maximum Slim
- North American Medical Corporation / Carlos Becerra (3/2/07): Accu-Spina device
- Pjzak Enterprises / Paul Zakrzewski (3/14/07): Sea Vegg
- Zeo Health Ltd (6/27/07): Destroxin, Esdifan, Zeo
This page was revised on January 22, 2011.