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.

No evidence was found to substantiate any of the charges. FDA has not approved gentian violet for use in veterinary products and has determined that gentian violet does not qualify for interim food additive status. The safety and effectiveness of gentian violet in veterinary use have not not been demonstrated, nor has its effectiveness as a mold inhibitor in animal feeds been demonstrated. According to FDA, the safety must be demonstrated in long-term tests designed to assess whether or not gentian violet is carcinogenic. The GAO review disclosed that the regulatory actions taken by FDA against three firms were not unreasonable in view of the FDA decisions that gentian violet products are unapproved as food additives and new animal drugs. In nine out of ten cases, FDA action has been upheld by the courts. One firm reviewed, Naremco, alleged that certain actions taken by FDA were unreasonable, overstepped agency authority, or deliberately attempted to discredit or drive the firm out of business. Although some statements made by FDA officials to Members of Congress were inaccurate, GAO could not conclude that these were deliberate attempts to discredit or drive the firm out of business. Officials of the other two firms reviewed believed that failure to gain approval for their products was a result of the FDA dealings with Naremco and that the FDA refusal to permit them to market gentian violet products was the result of the FDA desire to restrict Naremco from selling such products.