The US Food and Drug Administration (FDA) has denied a request for use of a qualified health claim that taking vitamin D may reduce the risk for multiple sclerosis (MS) in healthy people. “The FDA thoroughly reviewed the 85 publications submitted by the Burdock Group (Orlando, Florida) on behalf of Bayer, as well as all the publications cited in the petition’s appendix,” the agency notes in a Constituent Update posted January 12.
The agency also conducted what the statement describes as a “vast independent literature review of hundreds of additional publications. Through this rigorous assessment, the FDA determined that scientific conclusions could not be drawn about the relationship between vitamin D intake and MS risk,” it notes. “Based on the agency’s review of the totality of publicly available scientific evidence, the FDA has concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of MS.”
The statement explains that qualified health claims are those supported by “credible” scientific evidence but that do not meet the more rigorous “significant scientific agreement” standard required to support an authorized health claim.
“As such, qualified health claims must be accompanied by a disclaimer or other qualifying language so that the level of scientific evidence supporting the claim is accurately communicated,” the FDA statement notes.
“In the case of this qualified health claim petition, because there is no credible scientific evidence to support the claim, the claim is misleading and no disclaimer or qualifying language could mitigate the misleading concerns of the claim itself to prevent consumer misunderstanding.”
The agency is open to reassessment of its decision as new information becomes available, the update concludes.