FDA Warning Letters about Products (2015)
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.
- Irvine Stem Cell Treatment Center / Thomas A. Gionis, MD, JD, MPH (12/30/15): adipose-derived stem cells
- Pathway Genomics / Jim Plante (9/21/15): CancerIntercept Detect (cancer screening test)
- ONDAMED Inc. / Silvia Binder (6/1/15): Ondamed System
- ZYTO Technologies / Vaugn R. Cook (5/8/15): ZYTO hand cradle
This page was revised on June 24, 2016.