Responding to food manufacturers’ requests, the U.S. Food and Drug Administration (FDA) has published industry guidance to clarify when fruit and vegetable juices “may be used as color additives for foods without additional premarket review and approval from the agency under its color additive petition process.”

Under current regulations, the agency provides that “the safety of fruit juice and vegetable juice as color additives for use in food is assured by the fact that the fruit or vegetable from which the color additive is derived has been safely consumed as food, such that there would not be safety concerns in using the juice or water soluble color components from the fruit or vegetable as a color additive.” In particular, FDA clarifies what it means by the terms “fruit,” “vegetable,” “mature,” “fresh,” and “edible,” as well as “expressing the juice” and “water infusion of the dried fruit or vegetable.” The agency also states that the “only minimal processing methods may be used for the production of the color additives fruit juice and vegetable juice.”

“There may be circumstances under which a fruit or vegetable that is normally regarded as edible should not be used as a plant material for producing fruit juice and vegetable juice color additives,” notes the guidance. “For example, a plant material could contain a pesticide chemical that is unsafe within the meaning of section 408(a) of the FD&C Act (21 U.S.C. 346a(a)). In addition, the plant could be grown under environmental conditions which cause the plant to produce a deleterious substance which could cause detrimental health effects. Importantly, manufacturers are responsible for ensuring that their products meet all applicable FDA requirements before they are introduced into U.S. interstate commerce.”


Issue 626

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.