Last week, the FDA concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of multiple sclerosis (MS). The petition, submitted on behalf of Bayer, requested use of the claim “Vitamin D may reduce the risk of [MS]” as a qualified health claim. FDA previously denied a petition made by Bayer for a similar vitamin D claim under the more rigorous “significant scientific agreement” standard. Days after FDA denied use of the authorized health claim, Bayer resubmitted its petition for a more restricted qualified health claim (i.e., the claim includes the qualifying word “may”), which only requires support by “creditable evidence.”
Although Bayer’s petition included 85 publications and cited to a number of other publications, it failed to make the case for linking vitamin D consumption to reducing MS risk. In addition to reviewing publications submitted by Bayer, FDA conducted a vast, independent literature review of hundreds of additional publications.
Ultimately, FDA determined that many of the publications “did not contain sufficient information on the individual studies” and the agency, therefore, “could not draw any scientific conclusions.” For example, FDA could not determine study population characteristics or the composition of the products used from many publications. FDA explained that it requires detailed information to determine whether the studies were flawed in design, conduct, or data analysis. Other studies (both intervention and observational) evaluated vitamin D for treatment of MS, and were not relevant to risk reduction. Other studies were not considered by FDA because they failed to separate the impact of vitamin D from other nutrients included in the supplements tested.
Because FDA found there is no credible scientific evidence to support the claim, the agency determined that claim is misleading, and no disclaimer or qualifying language could mitigate the misleading concerns of the claim itself to prevent consumer misunderstanding.
For stakeholders considering applying for approval of a qualified health claim, FDA’s response (available here) provides some valuable detailed guidance on how the agency assesses studies and other support provided for qualified health claims.