The successful denial of an FDA health claim petition

History has shown approval of a dietary supplement health claim, given the requirement to demonstrate “significant scientific agreement,” to be a challenge, as evidenced by this tale of a claim related to vitamin D.

Karen Howard, CEO and executive director

June 30, 2020

1 Min Read
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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.

About the Author(s)

Karen Howard

CEO and executive director, Organic and Natural Health Association

Karen Howard, CEO and Executive Director of Organic and Natural Health Association, is a visionary and results-focused leader who has spent more than 30 years working with Congress, state legislatures and health care organizations to develop innovative health care policy and programs. She has held a variety of executive positions, including serving as professional staff for a Congressional committee, and has policy expertise in the diverse areas of integrative and complementary medicine, managed care, health care technology and mental health. An advocate at heart, she has worked to strategically advance the mission and vision of organizations through effective advocacy and strong collaboration. Prior to Organic and Natural Health, Howard served as executive director for both the American Association of Naturopathic Physicians (AANP) and the Association of Accredited Naturopathic Medical Schools. During her nearly 10-year tenure at AANP, she built a sustainable infrastructure, significantly improved financial performance, established a strong federal presence and supported multiple state association advocacy efforts for licensure. Also during this time, the naturopathic medicine profession established itself as a key component of comprehensive healthcare for the future. 

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