Amended Food Additive Regulations to Allow for Additional Use of Vitamin D3

The U.S. Food and Drug Administration (FDA) has amended food additive
regulations pertaining to the safe use of vitamin D3 in response to a petition
from Abbott Laboratories. The company requested that FDA approve use of the fat-soluble hormone “as a nutrient supplement at levels not to exceed
500 IUs per 240 mL in meal replacement beverages that are not intended
for special dietary use in reducing or maintaining body weight and that are
represented for use such that that the total amount of vitamin D3 provided by
the product does not exceed 1,000 IU per day, and at levels not to exceed 1.0
IU per kilocalorie in food represented for use as a sole source of nutrition for
enteral feeding.” Objections to FDA’s approval of Abbott’s petition or requests
for a hearing must be filed by September 11, 2014. See Federal Register, August
12, 2014.

Issue 534