The successful denial of an FDA health claim petition

In March 2018, Organic & Natural Health submitted a petition to FDA, 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 submission contained a two-foot stack of research documentation, including the results of a research study conducted at the Medical University of South Carolina (MUSC) with our research partner, GrassrootsHealth.

Every day in North America, more than 1,000 babies are born prematurely. The MUSC study showed pregnant women who maintain vitamin D levels of 40 to 60 ng/ml experienced a reduction in preterm births by up to 60 percent. Out of the 1,000 pregnant women studied, 90% were deficient in vitamin D. It is worth noting, during the study, researchers did not find a single complication related to pregnant women taking vitamin D.

Eventually we met with FDA. Earnest in its review and comments, the flaw in our submission centered around the field study, and a lack of control for study participants who may have elected to sunbathe during the trial.

One additional meeting later, we knew the petition would not be approved, nor would FDA approve a revised submission for a qualified health claim.

To learn more check out Innovation from the SupplySide East community, 2020 – digital magazine.

Check out The making of a supplement claim – webinar now on demand with featured speaker Karen Howard. 

Karen Howard is CEO and executive director of Organic & Natural Health, an association of consumer groups and quality organic and natural products companies.