September 22, 2011
To: John Miller, Chair, NAMA Nutrition Committee
From: Mary Waters
Re: NAMA Petition to FDA to allow wheat flour to be fortified with Vitamin D
As requested, here are the regulatory steps required to allow the inclusion of Vitamin D in the enrichment for refined wheat flour, as well as to whole wheat flour.
Vitamin D is a nutrient of concern in the American diet according to the Dietary Guidelines for Americans 2010 report. Vitamin D is essential for bone growth and maintenance. Inadequate vitamin D can cause rickets in children and osteomalacia in adults. Other roles of Vitamin D in human health include neuromuscular and immune function modulation and reduction of inflammation. Scientific evidence suggests that vitamin D is involved in risk reduction of certain cancers and diabetes.
Vitamin D occurs naturally in a limited number of foods. Most of the vitamin D in the U.S. diet is from fortified foods and dietary supplements. Vitamin D is unique in that sunlight on the skin enables the body to make vitamin D.
The RDAs for vitamin D, which assume minimal sun exposure, are 600 IU (15 mcg) per day for children and most adults and 800 IU (20 mcg) for adults older than 70 years. As intake increases above 4,000 IU (100 mcg) per day, the potential risk of adverse effects increases.
Vitamin D is regulated as a food additive and is therefore not allowed to be added into all foods. The regulations currently allow Vitamin D to be added to several grain ingredients and foods – corn meal, wheat farina, rice, macaroni products, noodle products and breakfast cereals, but not to refined or whole wheat flour.
NAMA does not have the internal expertise to submit a petition to FDA. We will need NAMA Member Companies to commit technical expertise and the cost of doing the supporting studies required by FDA. We can then ask Washington legal firms who have successfully submitted petitions to provide a cost estimate and timeline for developing a dossier and submitting a petition. Hogan and Lovells law firm has been used by NAMA member companies for FDA related work. A rough estimate of time and cost would be two to three years (depending on research progress) and $100,000.
Additional technical information that is needed to support a petition for adding vitamin D to refined and whole wheat flour includes:
Shelf life studies will be conducted under recommended ambient and stressed (warm) storage conditions, using frozen storage as the control.