- FDA Announces New Qualified Health Claim for Omega-3s! Grasssroots Health
- FDA Announcement
- It seems feasible to make similar claims for Vitamin D – there is a lot of “credible evidence”
- VitaminDWiki items in both categories Omega-3 and Cardiovascular
- See also - FDA allows the claim that Vitamin D “supports healthy pregnancies and promotes full-term births” – Oct 2019
- See also VitaminDWiki
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
It seems feasible to make similar claims for Vitamin D – there is a lot of “credible evidence”
2019 chart
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
VitaminDWiki items in both categories Omega-3 and Cardiovascular
- Omega-3 reduces many aspects of heart problems - Jan 2024
- Cardiovascular problems reduced by Omega-3 - many studies
- Cardiovascular problems are prevented by Vitamin D plus Omega-3 – Feb 2023
- Omega-3 decreases heart disease and COVID: Harris and Patrick, video and transcript - Dec 2021
- Atrial Fibrillation decreased by Vitamin D or Magnesium - many studies
- Omega-3 reduced cardiovascular deaths by 16 percent (427,678 people) – March 2020
- Synthetic EPA drug recommended to FDA for Cardio (Omega-3 is 8 X better) – Nov 2019
- Omega-3 reduces heart problems by ~5 percent – meta-analysis by Heart Association Oct 2019
- Cardiovascular Prevention with Omega-3 (finally using high doses) – Sept 2019
- Few people have enough EPA (an Omega-3) to reduce heart failures – July 2019
- Another Nail in the Coffin for Fish Oil Supplements (nope) – JAMA April 2018
- Omega-3 provides many cardiovascular benefits – April 2018
- Omega-3 helps the heart, AHA class II recommendation, more than 1 gm may be needed – March 2018
- 3 days of Omega-3 before cardiac surgery reduced risk of post-op bleeding by half – RCT March 2018
- Perhaps the Omega-3 optimal level is 10 percent, not 8 – Feb 2018
- Omega-3 Cardiovascular meta-analysis has at least 5 major problems – Jan 2018
- Benefits of Omega-3 beyond heart health - LEF Feb 2018
- Higher Omega-3 index (4 to 8 percent) associated with 30 percent less risk of coronary disease (10 studies) July 2017
- Cardiovascular problems reduced by low dose aspirin and perhaps Omega-3 (also Vit K) – Sept 2017
- Omega-3 reduced time in hospital and atrial fibrillation after cardiac surgery – meta-analysis May 2016
- For every Omega-3 dollar there is a 84 dollar savings in Cardiovascular costs - Foster and Sullivan April 2016
- High dose Omega-3 probably reduces heart problems – American Heart Association – March 2017
- Health problems prevented by eating nuts (perhaps due to Magnesium and or Omega-3) – meta-analysis Dec 2016
- Omega-3 – need more than 1 gram for a short time to reduce Cardiovascular Disease – Nov 2016
- Omega-3 is vital for health, mail-in test is low cost and accurate
- Cardiovascular calcification prevented by Omega-3, Magnesium, Vitamin K, and Vitamin D – April 2015
- Atrial fibrillation sometimes treated by Omega-3 – meta-analysis Sept 2015
- Salmon intervention (vitamin D and Omega-3) improved heart rate variability and reduced anxiety – Nov 2014
- Omega-7 - in addition to Omega-3
- Omega-3 reduces Coronary Heart Disease - infographic June 2014
- Cardiovascular diseases – conflicting data on benefits of Omega-3 and vitamin D – Feb 2014
- Cardiovascular system benefits from both Omega-3 and vitamin D – Dec 2012
- Heart problems such as Afib related to little Magnesium, Omega-3, Vitamin D getting to tissues
- Omega-3 does not help heart patients – meta-analysis Sept 2012
See also - FDA allows the claim that Vitamin D “supports healthy pregnancies and promotes full-term births” – Oct 2019
See also VitaminDWiki
- Call to action – more Vitamin D for pregnancies, loading doses are OK – Holick Aug 2019
- Note: Above chart shows lots of pregnancy evidence
- See also: Ensure a healthy pregnancy and baby - take Vitamin D before conception
- 4,000 IU of Vitamin D is OK - 19 organizations agree - 2018
- Need 40 to 60 ng of Vitamin D – 48 scientists call for action – 2015
- 86 Health Problems were proven to be fought by Vitamin D by Nov 2018
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823 Vitamin D Intervention Trials - FDA allows specific Mganesium and Hypertesnion claims as of Jan 2022
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