Petition to FDA Seeks Vitamin D, Preterm Birth Health Claim

The Organic & Natural Health Association (O&N) this week submitted a petition to FDA, requesting the agency permit dietary supplements containing vitamin D to make a health claim concerning the association between vitamin D and decreased risk of preterm births.

The organization believes its proposed health claim associating higher serum vitamin D levels and decreased risk of preterm birth will help raise awareness of preterm births, empower women to take affirmative steps for the health of their children, and also reduce the cost of health care associated with preterm births—an estimated $12 billion annually in the United States, according to March of Dimes.

“If 50 percent of preterm births could be prevented each year in the United States, there could be nearly $6 billion available for other health services and more than 225,000 families would be spared this trauma,” said Karen Howard, CEO and executive director of O&N, in a press release announcing the petition.

Every day in North America, more than 1,000 babies are born prematurely. In fact, 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, which reports 130 countries have lower preterm birth rates than the United States.

Per the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics, infant mortality is not improving in the United States. Women of Asian ethnic origin show the lowest rates of preterm births, at 8.6 percent, while African-American women experience the highest rates, at 13.75 percent of all births, CDC reported.

Recently published research conducted at the Medical University of South Carolina (MUSC) in partnership with GrassrootsHealth, demonstrated vitamin D’s potential to reduce the prevalence of preterm births. According to the research, pregnant women who maintain vitamin D levels of 40 to 60 nanograms per milliliter (ng/mL), benefited from a reduction in preterm births by up to 60 percent. Out of the 1,000 pregnant women studied, a shocking 90 percent were deficient in vitamin D. 

The research is part of O&N’s Nutrient Power consumer education campaign designed to advance nutrient research and educate consumers to improve health.

FDA’s current recommended daily intake (RDI) for vitamin D for pregnant women is 15 micrograms per day (mcg/d) or 600 international units per day (IU/d), largely based on dietary reference intakes determined by the Institute of Medicine (IOM). These recommendations rely heavily on research supporting the nutrient’s role in bone health and in addressing osteoporosis and rickets.

IOM advises those with serum levels of 25-hydroxyvitamin D (25(OH)D) lower than 30 nanomoles per liter (nmol/L) (12 ng/mL) are at risk of deficiency “relative to bone health,” while those between 30 and 50 nmol/L (12 and 20 ng/mL) are “potentially at risk for inadequacy.”

Referencing IOM’s recommendations, the petition stated, “These IOM efficiency/inadequacy/sufficiency designations are all related to the role of vitamin D in bone health; they do not contemplate the levels that are adequate to support maternal and fetal health during pregnancy, and in particular, the levels needed to help reduce the risk of preterm birth.”

The Endocrine Society, a U.S.-based organization, advises higher serum levels of vitamin D for health; 25(OH)D levels below 50 nmol/L (20 ng/mL) are considered deficient, and levels between 52.5 and 72.5 nmol/L (21 and 29 ng/mL) insufficient, based on vitamin D’s skeletal and extra-skeletal benefits. “Again, however, these guidelines were not developed specifically for maternal and fetal health,” the petition argued.

O&N’s proposed health claim would stand on research showing vitamin D “likely has more than skeletal benefits, and that it may have immunomodulatory and anti-inflammatory roles, making it crucial for pregnant women and their developing fetuses.” (Arch Biochem Biophys. 2012;523:37-47.)(Journal of Steroid Biochemistry and Molecular Biology. 2017. DOI: 10.1016/j.jsbmb.2017.12.011.)

To support its claim, O&N advised vitamin D₃ supplementation at doses as low as 1,000 IU/d and as high as 4,000 IU/d, based on human clinical studies evaluating the safety and efficacy of supplementation in pregnant and lactating women.

“Vitamin D at this higher level – 4,000 IU per day – has been recognized as safe by the IOM, which set the tolerable upper limit (UL) for vitamin D at 4,000 IU per day persons aged 9 or older and for pregnant and lactating women … However, even at daily dosages up to 10,000 IU, there is evidence that supplementation would be safe,” the petition stated.

Vitamin D deficiency has increased in the United States in recent years, according to National Health and Nutrition Examination Survey (NHANES) findings, and is prevalent among pregnant women. Limited sun exposure, increased use of sunscreen and limited food sources of vitamin D are among potential factors associated with deficiency. In the United States, pregnant women are also often advised to limit consumption of fish—a food source of vitamin D—due to contamination concerns.

“Within this context, then, dietary supplements are clearly an important way for the general U.S. population, and pregnant women in particular, to get necessary amounts of vitamin D₃,” the petition stated. “Indeed, researchers, health care professionals, and the U.S. federal government’s own Dietary Guidelines generally accept—and recommend—dietary supplements as an affordable and accessible way to ensure appropriate nutrient intake.”

O&N will take a select team to Capitol Hill to share its message on its April 12 Hill Day, meeting with key legislators and staff, and presenting the research at an informational luncheon at noon in room 340, the Cannon House Office Building. Members of Congress and the media are invited to attend.

“MUSC changed its standard of care for its pregnant patients and is now monitoring vitamin D levels based on their research,” Howard said in the release. “We are confident that members of Congress, their constituents, health insurers and employers will see the value in this health claim related to vitamin D levels and a reduced risk of preterm births.”

When asked to comment, FDA said it will respond to the petitioner following review of the petition.