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Vitamin D Petition to FDA

NAMA has drafted a petition to FDA to allow the addition of Vitamin D to flour. The draft petition and a supporting report on exposure levels that was prepared by Exponent was reviewed by the Nutrition Committee in June 2012. The NAMA petition seeks an amendment to the food additive regulation for vitamin D to allow the addition of up to 80 IU (2 mcg) vitamin D per 30 g of refined (enriched or unenriched) and whole grain bagged and bulk wheat flour; this use level corresponds to 20% of the Daily Value (DV) of vitamin D per Reference Amount Customarily Consumed (RACC) of flour (21 CFR 101.9(c); 21 CFR 101.12(b)). This would enable package labels to carry a claim of “excellent source of Vitamin D”.

In July 2012, NAMA representatives met with staff of the Office of Food Additive Safety (OFAS) and the Office of Nutrition, Labeling, and Dietary Supplements (ONDLS), both of which reside in FDA’s Center for Food Safety and Applied Nutrition, to discuss the planned submission of a food additive petition. Once filed, it is expected that FDA would take approximately 18 months to approve the petition, barring the submission of any comments that raise valid objections.

FDA raised no concerns with the draft petition. They noted that NAMA must still decide whether this will be for D2 or D3 and in what form (crystalline or resin).

In August 2012, the Nutrition Committee held a conference call and asked Dr. Beth Arndt, ConAgra Mills; Dr. Elizabeth Uriyo, Horizon Milling, LLC/Cargill, Inc; and Dr. Don Sullins, ADM Milling Company, to come back to the committee with a framework on how to conduct an in-house shelf life study. They also discussed whether to petition for D2 and D3.  They requested additional information on the cost of D2 and D3 and the history of folic acid costs.

On August 29 the FDA approved a petition submitted by Lallemand in 2009 to allow the addition of vitamin D2 bakers yeast (produced by UV light) as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. This is a patented process and the petition was supported by the American Bakers Association (ABA).

The Technical Committee discussed this effort at their September 2012 meeting. Issues raised included the need for another feeder in the mill (since it would not be part of the enrichment package), the resulting increased number of SKUs, and if D3 is chosen (animal based) the possible impact on kosher and Halal production in the mill.

Although there are bread products in stores with labels that say “excellent source of Vitamin D,” NAMA counsel is not aware of a legal basis for making this claim prior to FDA’s approval of Lallemand’s petition. NAMA’s counsel confirmed this view with ABA’s counsel.

It is possible that FDA would decide to increase the recommended level of Vitamin D. If a higher amount was later recommended NAMA would no longer be eligible to make the claim “Excellent Source” of Vitamin D with an 80 g serving.

In December 2012 the shelf life study working group (Drs. Arndt, Uriyo, and Sullins) had a follow up call to discuss the shelf life/stability study design.  Due to Don Sullins’ retirement, shelf life study responsibilities were divided between ConAgra and Horizon.  After several working group calls this summer, the study is beginning with delivery of refined and whole wheat flour to Caravan Ingredients for addition of a vitamin D (both D2 & D3) premix in September – early October 2013.

Prepared by Sherri Lehman, 202.484.2200, ext. 13

Last update September 25, 2013

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