WASHINGTON – The Food and Drug Administration concluded in a Federal Register notice on March 11 that objections to a final rule increasing the allowable use of vitamin D2 bakers yeast in baked foods do not provide a basis for amending or revoking the regulation. A.B. Mauri North America, St. Louis, made the objections.
The final rule appeared in the Aug. 29, 2012, issue of the Federal Register and came as a result of a petition from Lallemand, Inc., Montreal. The final rule authorized the safe use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (I.U.) of vitamin D2 per 100 grams in the finished food. Previously, the limit was 90 I.U. per 100 grams.
A Sept. 26, 2012, letter from AB Mauri North America contained two objections.
For one objection, the letter said the final rule is based on the incorrect assumptions that vitamin D2 levels in yeast may be controlled and declared accurately and that food manufacturers may use the yeast in a way that allows them to control the levels of vitamin D2 in finished products and accurately declare the level on labels of food products. To strengthen its objection, AB Mauri had an independent laboratory analyze samples.
According to the F.D.A., AB Mauri did not provide the manufacturer’s certificates of analysis so the vitamin D2 levels of the samples could be verified. Also, AB Mauri did not identify the analytical method used in the analyses of vitamin D2 bakers yeast and did not provide information on the samples that were analyzed. Additionally, the F.D.A. said certificates of analysis, which include vitamin D2 levels, are provided with each vitamin D2 bakers yeast product sold, thus allowing bakers to calculate the amount of vitamin D2 that each finished food product will contain.
For the second objection, AB Mauri questioned whether vitamin D2 is as affective for humans as vitamin D3 at similar levels. AB Mauri cited two peer-reviewed journal articles to support this claim.The F.D.A. said its evaluation of the Lallemand petition was based solely on the safety of the proposed use of vitamin D2 bakers yeast in yeast-containing baked goods. Expanding the scope of the final rule to provide for the safe use of vitamin D3 was beyond the scope of the petition, according to the F.D.A.