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FDA allows specific Omega-3 health claims - July 2019

FDA Announces New Qualified Health Claim for Omega-3s! Grasssroots Health

  • On June 19, 2019, the U.S. Food and Drug Administration (FDA) announced "that it does not intend to object to the use of certain qualified health claims stating that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease.”
  • “While the FDA did not find evidence for the claim to meet the "significant scientific agreement" standard necessary to include an authorized health claim, it did meet the "credible evidence" standard that allows for a qualified health claim.”

FDA Announcement

FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease

  • “The FDA thoroughly reviewed the 717 publications cited by the petitioner. The FDA also considered other written data and information, including studies published after the petition was submitted and studies cited in public comments about the petition.”
  • “…petition submitted by The Global Organization for EPA and DHA Omega-3s
  • Qualified Health Claims: Letters of Enforcement Discretion
    • None for vitamin D as of July 2019

It seems feasible to make similar claims for Vitamin D – there is a lot of “credible evidence”


Would be nice to have a Vitamin D group which would benefit from FDA approving “credible claims”
Would probably need >$30,000 to petition the FDA
Unfortunately, unaware of a group that would benefit

See also VitaminDWiki

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