BACKGROUND:

It has come to our attention that gentian violet has been added to grains shipped to certain countries that require coloring (or decharacterizing such as crushing or grinding) of imported feed grains. Gentian violet is not permitted as a color in food or feed in the United States. Studies at the National Center for Toxicological Research have shown gentian violet to be a carcinogen for laboratory animals.

USDA's Federal Grain Inspection Service issued guidelines to its field offices, advising them to contact FDA field offices when they learn that an exporter wants to add food or color additives to grain.

POLICY:

Because of our concern about the lack of safety of gentian violet as well as other unapproved additives for use on grains, we will insist on evidence from the exporter that the conditions of section 801(d) of the FD&C Act are met. Evidence that the product is not in conflict with laws of the foreign country [section 801(d)(1)(B)] must be in writing from the appropriate foreign government regulatory agency or their embassy in the United States. Contact the Division of Compliance (HFV-230), Center for Veterinary Medicine, for guidance regarding grain intended for animal use or Center for Food Safety and Applied Nutrition *(HFS-605)*, for guidance regarding grain for human food if there is a question regarding the safety of the substance being added to the grain.* If the Center(s) believes that additional information regarding hazards should be provided to the foreign government, or that exportation is hazardous to the public health and safety, it will consult with the Office of Regulatory Affairs.

*Material between asterisks is new or revised*

Issued: 2/1/84

Revised: 6/6/88, 3/95