The FDA accepted a health claim for magnesium, but somehow still manages to censor information on this critical nutrient. Action Alert!
Earlier this month, the FDA announced it will allow a health claim regarding magnesium and hypertension. The agency admits there is scientific support that magnesium helps with high blood pressure…but the evidence is “inconsistent and inconclusive.” Huh? Rather than using qualifiers to downplay the evidence for magnesium, shouldn’t the FDA, a public health agency, be more concerned about the fact that nearly half of American adults have high blood pressure? High blood pressure increases the risk for heart disease and stroke, which are the leading causes of death in this country. Shouldn’t the FDA be thrilled that there is a lot of credible evidence that a nutrient as safe, affordable and readily available as magnesium can help with lowering blood pressure and preventing coronary artery disease? Unfortunately, we have yet another example of the FDA being more concerned with protecting drug industry profits than with promoting public health through the use of safe, effective, and affordable natural medicines.
The FDA’s action was in response to a petition to allow what was already a measured health claim about 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, according to the FDA, went too far! Instead, the agency will allow companies to say that “inconsistent and inconclusive evidence” suggests that magnesium “may” reduce the risk of high blood pressure. In detailing its rejection of this claim, the FDA seems to contradict the findings of agencies less influenced by the drug industry.
To reach its determination, the FDA reviewed 88 publications. Fifteen studies were disregarded because the subjects had hypomagnesaemia, those with abnormally low concentrations of magnesium in their blood, which, the FDA claims, is not representative of the general population. Yet government surveys, as part of a joint effort from the Departments of Health and Agriculture, have found that 60 percent of Americans do not ingest enough magnesium to meet minimum daily requirements. So, most Americans are, indeed, deficient, yet the FDA seems unwilling to acknowledge this basic truth.
Why does this matter? Hypertension is one of the top risk factors for heart disease, the leading cause of death both worldwide and in the US. High blood pressure can be caused by several conditions, such as the inflexibility of blood vessels, hardening of arteries, and an overactive stress response; low magnesium impacts all of these factors. The scientific evidence on magnesium and heart health is extremely compelling:
- A large study in 2020 concluded that low magnesium was a significant risk to the heart.
- Other clinical trials have shown that lower magnesium in patients is associated with higher blood pressure.
- A meta-analysis of large studies with more than 2,000 subjects found that supplementation with magnesium reduces blood pressure in hypertensive patients.
- Studies have demonstrated an association between low magnesium and risk for heart attack and stroke.
- Magnesium stimulates the production of calcitonin, a hormone that removes calcium from the soft tissues and blood, reducing the risk of heart attacks.
“Inconsistent” and “inconclusive,” indeed! Other evidence has found that low magnesium is associated with arterial fibrillation, which occurs when a malfunction in the heart’s electrical system causes the upper chambers of the heart to quiver.
Part of the problem is that standard blood tests vastly underestimate magnesium insufficiency. The current “normal” range was established based on magnesium levels gathered by a study between 1971 and 1974 of “presumably healthy” individuals—but what constitutes healthy? One review of this topic concluded:
The traditional method to establish a reference interval for the serum magnesium is flawed by the large number of ‘normal’ individuals who have a subtle chronic negative magnesium balance due to a significant decrease in magnesium intake over the past century.
Common drugs also deplete magnesium. Acid blockers like Prevacid, Nexium, and Prilosec, which are taken by more than 15 million Americans, are now required to carry a block box warning indicating they can cause magnesium deficiency. Diuretics, commonly used for high blood pressure, can also reduce magnesium—which should be especially concerning given the information cited above.
With regard to the FDA’s action, it may be relevant to state that the global market for antihypertensive drugs will grow to nearly $26.3 billion. Ex-FDA officials have stated that the FDA sees the drug industry as its client and represents its interests. This is the same agency that went after cherry and walnut growers for citing peer-reviewed studies about the benefits of those products. The FDA’s actions say it all: to protect drug industry profits, they will aggressively censor information about the scientifically proven benefits of natural products. Even by allowing a qualified health claim about magnesium, the FDA has managed to censor the science on this critical nutrient. Until we address this broken system, we will continue to pay skyrocketing costs for healthcare that is expensive, dangerous, and often doesn’t work.
In the end, there is nothing very surprising about the FDA’s actions in this case. It has always been the agency’s goal to limit the information that can be communicated about the benefits of natural products. ANH, along with other stakeholders, had to sue the FDA to establish qualified health claims, which characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. Like with the magnesium claim discussed above, the FDA has a history of being forced to accept a qualified health claim but weakening and complicating the approved language to make the claim all but useless. ANH and others successfully sued the FDA when it played this game with claims for vitamin C and gastric cancer, vitamin E and bladder cancer, and selenium and cancer, with the Court finding that the FDA had “completely eviscerated” the claims with qualifying language.
For the FDA, it’s a “pay to play” game: unless you pay the astronomical sums for FDA approval, you’re shut out of the medical system. Supplements, not being strongly patentable, cannot afford to go through FDA approval, so the FDA does what it can to throttle access to and information about these health products.
Help us reform this broken system by supporting legislation that allows the free flow of information about the benefits of supplements.
Action Alert! Write to Congress supporting legislation that allows the free flow of information about the benefits of supplements. Please send your message immediately.
2 thoughts on “FDA Raising Our Blood Pressure”
The FDA needs reform. My husband, Clifford Moravetz and I believe the FDA is “in bed with” the pharmaceutical companies and is opposed to any information that might compete with pharmaceuticals. We need legislation to remedy this situation. We are also not happy with the way the FDA has handled the COVID vaccine approvals and the reports of health problems caused by these vaccines. We do not believe they are doing their job. They are in the pocket of the pharmaceutical companies instead of watching out for the citizens of the U.S.A.! There are employees of drug companies going to the FDA for jobs and vice versa. There should be laws stating that this swinging door between drug companies and the FDA cannot operate!
Thank you for this article about the new FDA Healthclaim.
A. Rosanoff, Ph.D.
CMER Center for Magnesium Education & Research