In 2018, Organic & Natural Health submitted a petition to the Food and Drug Administration and had two follow-up meetings, requesting that the agency permit dietary supplements containing vitamin D to make a health claim concerning the association between vitamin D and a decreased risk of preterm births.
WASHINGTON, Oct. 10, 2019 (GLOBE NEWSWIRE) -- The work Organic & Natural Health Association put into action along with research partner, GrassrootsHealth around the promotion of vitamin D for healthy pregnancies is finally making its debut on vitamin D product labels with Naomi Whittel’s company, Simply GOODFATS being the first to market a new structure/function claim on its vitamin D3 product.
In 2018, Organic & Natural Health submitted a petition to the Food and Drug Administration and had two follow-up meetings, requesting that the agency permit dietary supplements containing vitamin D to make a health claim concerning the association between vitamin D and a decreased risk of preterm births. The petition was based on numerous 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 although vitamin D is a food source, serum levels of vitamin D are not considered food or components of food, therefore cannot be characterized as a substance to decrease the risk of preterm births.
“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,” said Karen Howard, CEO and executive director of Organic & Natural Health. “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.”
Simply GOODFATS Vitamin D3 label will be the first product to include “supports full-term birth” and “supports a healthy pregnancy” along with a 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.
“I’m exited to finally get this information out to women and families, right on our vitamin D3 product label, where they need to see it,” said Whittel, who also serves on the board of directors of Organic & Natural Health. “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.”
Published research conducted at the Medical University of South Carolina in partnership with GrassrootsHealth, shows pregnant woman who maintain vitamin D levels of 40-60 ng/ml, experience a reduction in preterm births by up to 60%. Out of the 1,000 pregnant women studied, 90% were deficient in vitamin D. During the study, researchers did not find a single complication related to pregnant women taking vitamin D.
“I don’t see a downside to telling pregnant women to take vitamin D,” said Dr. Kecia Gaither, double board-certified physician in OB-GYN and Maternal Fetal Medicine and scientific advisory council member for Organic & Natural Health. “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 March of Dimes estimates that the annual cost of preterm births in the United States is $12 billion, for 455,918 children. Every day in North America, more than 1,000 babies are born prematurely and the United States has the highest rate of babies who die at birth in the industrialized world according to Save The Children, which reports that 130 countries have lower preterm birth rates than the United States.
Organic & Natural Health Association advances research to redefine how health care is delivered, provides quality education to inform and empower conscious consumer choice and advocates for meaningful public policy. Its Nutrient Power consumer education campaign advances nutrient research and educates and empowers consumers to take charge of their health. Learn more at www.organicandnatural.org, and follow on Facebook and Twitter.
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