The Vitamin D Petition - An Update
O&N had its first meeting with FDA regarding the Vitamin D Petition in September. In addition to our highly skilled Venable team, we were joined by Carole Baggerly and Dr. Roger Newman. Dr. Newman is the head of MUSC’s OB/GYN department as well as the University’s Research Department.
Overall, we were extremely pleased with FDA’s genuine interest in our Petition, the participation of a very large team from FDA, and their knowledge on vitamin D itself.
The presentation was thorough, providing documentation for our health claim and addressing what we knew would be the most difficult issue for FDA, accepting the validity of data derived from nutrient levels vs. nutrient dosing.
The FDA’s primary point of discussion related to the study not containing controls for ensuring changes in vitamin D levels resulted solely from dietary supplementation (versus tanning in the sun). It is indeed unlikely, if not simply incomprehensible that pregnant women of limited means would adopt tanning practices once pregnant and participating in a vitamin D study. However, this FDA's worldview and thus, our reality.
The process requires that FDA respond to the petition by December 10. They have the option of posting it for public comment, which we are advocating they do. They also have the ability to reject the petition outright without posting for public comment.
While we can't predict the outcome of this particular effort, we can promise that O&N is committed to sharing quality research outcomes on the power of nutrients in any and every way possible.