Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations authorizing the use of vitamin D<INF>3</INF> as a nutrient supplement in calcium-fortified fruit juices and fruit drinks, excluding fruit juices and fruit juice drinks specially formulated or processed for infants, at levels not to exceed 100 International Units (IU) per serving. (In the final rule, FDA used the term "fruit drink;" however, the common or usual name of the product is "fruit juice drink." Therefore, FDA is replacing the term "fruit drink" with "fruit juice drink.") In response to one of the objections, FDA is amending the vitamin D<INF>3</INF> regulation to replace the current 100 IU per serving limits on the vitamin D<INF>3</INF> fortification of fruit juices and fruit juice drinks with limits of 100 IU per 240 milliliters (mL). This document also corrects three errors that appeared in the codified portion of the vitamin D<INF>3</INF> final rule.