Story at a glance:
- On Monday January 10th, 2022, the FDA confirmed that Magnesium may reduce the risk of High Blood Pressure. (source)
- Magnesium is an essential electrolyte that must be obtained from food (leafy greens, almonds, etc.) and/or magnesium supplements, such as Jigsaw Health MagSRT®. (source)
- The CDC estimates that 45% of Americans (116 million) have high blood pressure. (source)
- Other than measuring your blood pressure, there are generally no physical signs of high blood pressure -- the American Heart Association refers to high blood pressure as a "symptomless, silent killer.” (source)
- Left untreated, high blood pressure can lead to stroke, heart attack, and other health problems. (source)
- During the Scottsdale Magnesium Study (2017-2019) Jigsaw Health MagSRT® was tested in a human clinical trial showing an 11% decrease in Systolic Blood Pressure over 90 days in individuals with untreated, Stage 1 Hypertension.*
More details and links to sources are included throughout the rest of the story below...
Story in-depth:
On Monday January 10, 2022, an historic announcement was made: FDA will now allow certain qualified health claims for Magnesium and High Blood Pressure.
More specifically, FDA stated they will now allow the following statement to be used on the labels (or in the labeling of) conventional foods and dietary supplements containing magnesium:
“Supportive but inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
This is exciting because at Jigsaw Health, we've been sitting on some very interesting data for the last 2 years...
During the Scottsdale Magnesium Study (2017-2019), researchers (Weiss, Brunk, and Goodman) discovered that Jigsaw Heath MagSRT® decreased Systolic Blood Pressure (SBP) by 11% over 90 days in individuals with untreated, Stage 1 Hypertension.*
SBP dropped from 145 to 129; this difference was significant compared to a placebo group.*
Furthermore, 30 days after MagSRT® supplementation ended, both systolic and diastolic blood pressure reverted to baseline values; SBP went back up from 129 to 144.*
The research team submitted these findings to the American Heart Association in April 2019. But in August 2019, the paper was rejected with the following, vague explanation:
“The number of abstracts submitted continues to grow substantially, and unfortunately, many good papers could not be included in the program. We hope this does not discourage you from future submissions and we hope to see you [at the conference] in Philadelphia.”
At that time, we chose not to publish this blood pressure data because – on the advice of regulatory counsel – we were concerned that even though we had good data, the FDA may penalize us for attempting to make a “drug claim” for Jigsaw MagSRT. Because, as a matter of regulatory definition, dietary supplements are not intended to diagnose, treat, cure, or prevent any disease. And hypertension is a disease.
Ironically enough, prior to submitting the paper to AHA, we shared the findings with Dr. Andrea Rosanoff, the Director of the Center for Magnesium Education & Research. Dr. Rosanoff was part of the team that submitted this petition to the FDA in October 2016. And she was very impressed with our findings, stating:
“[The Scottsdale Magnesium Study] certainly matches what we found – effective on high BP people, but doesn’t affect those with lower BP. Striking that BP goes right back up when the supplementation was stopped!”
So where do we stand today? This exciting news from the FDA is so new that we're not entirely clear what it means for the dietary supplement industry as a whole at this time. But we're hopeful that the Scottsdale Magnesium Study can be a useful data point in this on-going discussion about the importance of Magnesium.
Links to related stories:
- FDA approves qualified claim for magnesium and blood pressure
- FDA will allow qualified health claims for magnesium and reduced risk of high blood pressure
- PUBMED: Oral magnesium supplements decrease high blood pressure (SBP>155 mmHg) in hypertensive subjects on anti-hypertensive medications: a targeted meta-analysis (Rosanoff & Plesset)
- Scottsdale Magnesium Study
