The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or object to some qualified health claims regarding magnesium and the reduced risk of high blood pressure (hypertension), so long that the claims are worded properly to avoid misleading the consumer. The claims are essentially accompanied by a disclaimer to convey the available scientific evidence that supports the claim.
The Center for Magnesium Education and Research LLC. has sent a petition to the FDA to allow a health claim regarding the consumption of magnesium and a reduced risk of high blood pressure. Thus, confirming and characterizing a relationship between the ingredient and a disease or health condition. In this case magnesium and blood pressure.
Upon review of the submitted evidence, FDA has decided that there is a valid support for such a claim to be made for conventional foods and dietary supplements. FDA has released a guide for how they will enforce this new claim.
The following health claims for conventional foods and dietary supplements are included in the FDA’s letter:
- “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
- “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
- “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”
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It is strongly encouraged that your conventional food and/or dietary supplement labels capture the full statements issued by the FDA. We recommend using the statement verbatim to avoid misleading the consumer.
The amount of magnesium required to justify such a claim is 84 mg. Please ensure your conventional food or dietary supplement product does not also contain high levels of total fat, saturated fat, cholesterol, or sodium as these ingredients may disqualify your claim.
The full petition and FDA response reports are available online and in the resource links below. Please reach out if you have any questions about blood pressure or magnesium claims.
FAQs
What does the new FDA qualified health claim for magnesium say?
The FDA’s Letter of Enforcement Discretion says conventional foods and dietary supplements may claim that diets with “adequate magnesium” can reduce the risk of high blood pressure (hypertension). However, because the science is “inconsistent and inconclusive,” the claim must include disclaimers clarifying this.
What wording is acceptable for labels making this claim?
Labels must use one of the FDA-approved formulations, for example:
“Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
Or “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure … however, the FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”
What amount of magnesium is required to make this claim?
The product must contain at least 84 mg of magnesium to qualify for this health claim. Also, the product should not have high levels of total fat, saturated fat, cholesterol, or sodium, since those may disqualify it from making such a claim.
Which products are affected by the FDA’s decision?
Both conventional foods and dietary supplements can use this claim, provided their labels comply with the approved wording, the magnesium content requirement, and do not run afoul of disqualifiers like high fat or sodium content.
What is the risk if a product misuses or mislabels this claim?
Misuse or misleading language may lead to regulatory action by the FDA. If the claim does not include the required disclaimer or is worded in a way that overstates the evidence, the product could face enforcement for false or misleading claims. Ensuring label accuracy and compliance is essential.
