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FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS

  • Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements of a substance and a disease or health-related condition.  In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.  Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. A “qualified health claim” must be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim.

  • FDA denied a request for the use of a qualified health claim suggesting that the consumption of vitamin D may reduce the risk of developing multiple sclerosis (MS) in healthy individuals. The petition, submitted on June 3, 2016, requested that FDA authorize the claim for use on the labels of conventional food and dietary supplements containing vitamin D. In a letter to the petition submitter, FDA stated that after reviewing 85 publications submitted with the petition and all of the publications cited in the petition’s appendix, and conducting an independent literature review, it concluded that “there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of MS.”

  • FDA also stated that it considered the use of a disclaimer or qualifying language to accompany the proposed claim for Vitamin D intake and a reduction in the risk of multiple sclerosis, but concluded that neither would suffice to prevent consumer deception. FDA concluded the letter by stating that it would evaluate any new scientific information that becomes available that supports the use of a qualified health claim or significant scientific agreement if it is submitted to the Agency.

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 16
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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