“It is estimated that anywhere from 70% to 90% of people are vitamin D deficient, and the implications for that are pretty far reaching,” including a clear correlation between preterm birth and vitamin D serum levels below 40 ng/ml, said Karen Howard, CEO and executive director for the Organic and Natural Health Association.
“The rate of preterm births is not going now. The death rate of infants is not going down. These things are actually trending up. Slowly, but they are trending up,” she added, emphasizing that increased vitamin D could help turn the tide.
Given this risk and research that shows supplementation with 1,000-4,000 IU of vitamin D3 can increase serum vitamin D levels into a range associated with a decreased risk of preterm birth, the association submitted to FDA in late March a petition asking for a health claim that states: “Pregnant women who have higher serum vitamin D levels have a decreased risk of preterm birth. Adding a vitamin D3 supplement to your healthy diet can help increase your serum vitamin D levels. Your healthcare practitioner can measure your serum vitamin D levels and determine the appropriate dosage of vitamin D3 for you.”
With all the relevant research, the petition is “about a foot thick,” but also “well done,” said Howard, who is confident the FDA will approve the claim based on “all this great research that is being done.”
Despite significant research, petitions to FDA can take years to review and garner a response. The association hopes to streamline the process in part by asking legislators and consumers to write to FDA about their support for the health claim and to keep the issue on a front burner for the agency.
“We are asking that a letter be sent to [FDA Commissioner] Dr. [Scott] Gottlieb, supporting the petition and promulgating a regulation,” Howard said. She added that she believes Gottlieb will be receptive to the message given recent “progressive" statements that he has made about the role of nutrition in preventive health maintenance.
“FDA has a track record for being primarily about safety: biosecurity of our food supply, HACCP. They have never had a preventive health mission statement. So for the commissioner to come out and publically state that we need to rethink how we deal with nutrition in relationship to disease is a very positive sign,” Howard said.
She added: “We have hit a nexus where health care costs, our expenditures, are continuing to go up, outcomes continue to go down, where people are beginning to look to … the original way of taking care of yourself through nutrition. I think it is a good time to be here.”
Supplementation could dramatically reduce healthcare costs
The association also appealed to legislators’ desire to save the government money by highlighting the potential of vitamin D3 supplementation to reduce health care costs.
In a sample letter that the association left with legislators to send to Gottlieb, the group cites March of Dimes data that the annual cost of preterm births in the US is $12 billion for 455,218 children. It adds that if half of these could be avoided through vitamin D supplementation there could be nearly $6 billion available for other health care services.
“What an easy thing to do to be able to promote vitamin D, which costs $100 to give a woman throughout her pregnancy, with such a dramatic result,” Howard added.