Earlier this year, the Food and Drug Administration announced updated food additive regulations that would allow manufacturers of milk to add more vitamin D to their products so they could continue to claim the product is an excellent source of vitamin D under the new Nutrition Facts label regulations. The food additive updates, however, conflicted with the Pasteurized Milk Ordinance, which regulates all Grade “A” products. IDFA asked FDA’s Milk Safety Branch for regulatory discretion, which FDA granted this week in a memorandum of information.
FDA’s final rule on nutrition labels included changes to the recommended amount of nutrients, or Daily Values (DV). To match the Daily Value increase in vitamin D, the food additive regulations were also amended, allowing companies to double the previous maximum level of vitamin D3, with increases up to 84 IU per 100 grams of milk or 800 IU per quart of milk. However, no changes were made to the standard of identity for milk, which still provides for only 400 IU of vitamin D per quart of milk and is listed in Appendix O of the PMO, which regulates vitamin fortification of Grade “A” fluid milk products.
The memorandum (M-I-16-16) states, “FDA recommends Regulatory Agencies to exercise regulatory discretion during routine regulatory inspections. FDA will also instruct Milk Sanitation Rating Officers (SROs) and FDA Regional Milk Specialists (RMSs) to extend similar discretion during ratings and check ratings, respectively, by not debiting milk plants related to the vitamin D fortification requirements currently cited in Appendix O of the PMO.”
IDFA will work with FDA to ensure that the 2017 edition of the PMO will include the new fortification levels in Appendix O.
Higher Levels Require Disclosure Statement
When milk is fortified to higher levels of vitamin D, it must describe the milk as “high vitamin D” in a claim on the front of the package. It also requires a disclosure statement to appear after vitamin D in the ingredients list that says “*ingredient in excess amount permitted in regular milk.”
For more information, contact Cary Frye, IDFA vice president of regulatory and scientific affairs, at cfrye@idfa.org or Michelle Matto, IDFA’s nutrition and labeling consultant, at amfoodnutrition@gmail.com.