January 12, 2017
The U.S. Food and Drug Administration today denied a request for use of a qualified health claim that consumption of vitamin D may reduce the risk of developing multiple sclerosis (MS), a chronic autoimmune disorder that damages the body’s central nervous system.
The FDA thoroughly reviewed the 85 publications submitted by the Burdock Group on behalf of Bayer, as well as all the publications cited in the petition’s appendix. The agency also conducted 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. 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.
Qualified health claims are claims supported by credible scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for 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.
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.
Note that scientific information is subject to change, as are consumer consumption patterns. As new information becomes available, FDA is open to assessing whether it necessitates a change in this decision.
For More Information
- FDA Response to Petition for a Qualified Health Claim for Vitamin D and Reduced Risk of Multiple Sclerosis
- Questions and Answers: Qualified Health Claims in Food Labeling
- Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
- Qualified Health Claims: Letters of Denial