FDA's Regulation of Gentian Violet Appears Reasonable

Gentian violet, a dye, has been used as an animal drug to treat many diseases and as an additive in animal feed to inhibit mold. When drugs are to be used in food-producing animals, the Food and Drug Administration (FDA) must approve the safety of any residues in food. FDA actions in regulating gentian violet have been questioned. GAO was asked to determine whether some FDA officials exhibited malice against certain companies and individuals; the FDA regulatory machinery was improperly used to force some companies out of the market; and FDA was unresponsive to efforts made in good faith by three companies to resolve problems concerning the adequacy of safety and effectiveness data they submitted to FDA.