Washington, D.C.—Thanks to work from the Organic & Natural Health Association (O&N) and research partner GrassrootsHealth, FDA has opened the door for vitamin D supplements to include language on their labels indicating that vitamin D supports full-term births and healthy pregnancies, according to a press release.
In 2018, O&N submitted a petition to FDA and had two follow-up meetings requesting that the agency permit the health claims. The petition was based on several studies showing an association between higher serum vitamin D levels in pregnant women and a reduced risk of preterm births. This year, the petition was rejected—based on FDA’s decision that serum levels of vitamin D are not food or components of food, and therefore cannot be characterized as a substance to decrease the risk of preterm births.
Karen Howard, CEO and Executive Director of O&N, said in the release: “It’s an interesting position they took, that actually opens the door for companies with vitamin D supplements to include language on their labels that supports healthy pregnancies and promotes full-term births. Given FDA’s conclusion that the proposed health claim can’t be based on nutrient serum levels, only on how much vitamin D people take, we conclude it is appropriate, and essential, to educate consumers on how vitamin D affects the body’s function during pregnancy and reduces the risk of preterm birth.”
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The claims will debut with Naomi Whittel’s company Simply GOODFATS. The company’s Vitamin D3 label will carry the following structure/function claim:
Pregnant women who have higher serum vitamin D levels have a decreased risk of preterm birth. Adding a vitamin D3 supplement to a healthy diet can help increase serum vitamin D levels. Your healthcare practitioner can measure serum vitamin D levels and determine appropriate dosage of vitamin D3 for you.
Whittel, who also serves on the board of directors of O&N, said in the release: “I’m excited to finally get this information out to women and families, right on our vitamin D3 product label, where they need to see it. I know this information will not only help raise awareness on preterm birth prevention, but also empower women to take positive steps for the health of their families.”
“I don’t see a downside to telling pregnant women to take vitamin D,” Dr. Kecia Gaither, double board-certified physician in OB-GYN and Maternal Fetal Medicine and scientific advisory council member for Organic & Natural Health, said in the release. “Vitamin D is inexpensive and if just 50% of preterm births could be prevented each year in the United States, hundreds of thousands of families would be spared this heartache and trauma.”
The release cites the March of Dimes, which estimates that 455,918 children are born prematurely in the United States every year. Save The Children estimates that the United States has the highest rate of babies who die at birth in the industrial world, and that 130 countries have lower preterm birth rates than the United States.