ONHA files petition for health claim on Vitamin D and fewer preterm births

29-Mar-2018 - Last updated on 29-Mar-2018 at 15:31 GMT

The Organic & Natural Health Association has submitted a citizen’s petition asking FDA to approve a health claim connecting vitamin D supplementation with a reduction in premature birth risk.

The nutrition trade organization has asked the FDA to acknowledge numerous studies showing an association between higher serum vitamin D levels in pregnant women and a reduced risk of preterm births. The organization said it believes that such a claim will help raise awareness of preterm births, a risk factor for pregnant women, reduce the cost of health care associated with preterm births, and empower women to take affirmative steps for the health of their children.

US ranks low on scale

ONHA said that every day in North America, more than 1,000 babies are born prematurely. The United States has the highest rate of babies who die the day they are born in the industrialized world according to Save The Children. According to statistics from the Centers for Disease Control the situation is not improving. Women of Asian heritage living in the US show the lowest rates of preterm births, at 8.6%, while African-American women have the highest, at 13.8%.

Recent research conducted at the University of South Carolina shows how vitamin D supplementation can help, ONHA says. Data from more than 1,000 women and babies confirmed previous research at the Medical University of South Carolina, which found that blood levels of vitamin D of at least 40 ng/ml (100 nmol/L) lowered the pre-term risk by 59%, compared to women with concentrations less than 20 ng/ml (the current sufficient level recommended by the Institute of Medicine).

“These findings are another powerful example of the importance of the environment in our human health,” said Roger Newman, MD, Dir. OB/Gyn, Medical University of South Carolina. “Our evolution away from sun exposure over the last hundred years has resulted in widespread Vitamin D deficiency which contributes to multiple health consequences including higher and racially disparate preterm birth rates.”

Scientists from GrassrootsHealth, The University of Texas MD Anderson Cancer Center, and the Medical University of South Carolina Children's Hospital assessed maternal levels of 25-hydroxyvitamin D (25(OH)D) in a diverse population of women, and reported their findings in PLoS One .

“Vitamin D is inexpensive and has been shown to be safe at the recommended level,” said Carole Baggerly, director of GrassrootsHealth and co-author of the paper. “We have several medical centers ready to implement a new standard of care with our vitamin D ‘Protect Our Children NOW’ campaign.”

Other OHNA activity

This is not the first citizen’s petition filed by OHNA. In 2015 the organization petitioned to have GMP requirements extended to ingredient suppliers. This deliberate omission was done to reconcile the cost of the rule when the GMPs were first put into place starting in 2007.

It’s not clear what, if any, action FDA took on the previous petition. In any case, new requirements under the Food Safety Modernization Act that now apply to ingredient suppliers have rendered more or less moot the question of whether GMP rules under DSHEA ought to be extended to cover them.

At one point the OHNA, which was founded in mid 2014, also planned to create a ‘natural’ certification. When that effort was abandoned in 2016, the organization said it was still committed to coming up with a definition of the term ‘natural’ that was recognized in regulation. That effort appears to have been but on the back burner, too. The OHNA mission statement now says the organization’s purpose is to: “Unite consumers and corporations and transform business practices in alignment with regenerative systems to support the health of people and planet.”