Safety advisory · HFP Constituent Updates

Vitamin D and Multiple Sclerosis Health-Claim Petition: FDA Safety Advisory (Sep 3, 2024)

Agency action: Sep 3, 2024Record ID: hfp_constitu-481b815c583b4cb0
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What happened

Original notice title

FDA Denies Qualified Health Claim Petition for Intake of Vitamin D to Reduce the Risk of Multiple Sclerosis in Healthy People

From the archived source record

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. 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. FDA Response to Petition for a Qualified Health Claim for Vitamin D and Reduced Risk of Multiple Sclerosis

What the official notice says to do

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Status and source details

Status recorded in the archive
Published FDA communication
Source checked
Jul 16, 2026
Record revision
fc7bbc1c1f6b

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
FDA Denies Qualified Health Claim Petition for Intake of Vitamin D to Reduce the Risk of Multiple Sclerosis in Healthy People
Company
Not specified
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.