The FDA has just announced that it will not object to using certain qualified health claims regarding magnesium supplementation and the reductions in the risks of high blood pressure as long as the claims are not misleading to consumers and certain other factors for claim use are met.
This decision was made in response to a health claim petition filed on behalf of the Center for Magnesium Education and Research LLC back in 2016. The FDA has authorized the following claims:
- Inconclusive and Inconsistent evidence suggests diets with adequate levels of Magnesium may reduce the risk of hypertension (High Blood Pressure).
- Consuming a diet with adequate levels of Magnesium may reduce the risk of Hypertension (High Blood Pressure). However the FDA has concluded that the evidence is inconclusive and inconsistent.
- Some scientific evidence suggests diets with adequate Magnesium may reduce the risk of Hypertension (High Blood Pressure), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.
In order to use any of these claims the supplements or foods must meet these requirements:
- The product must contain enough Magnesium to have an effect. The FDA has established that in this case the product must contain at least 20% of the daily value for Magnesium which would work out to be 84 mg of Magnesium per serving.
- The product must contain levels of Magnesium deemed to be safe to ingest. The FDA has determined that the Upper Level Tolerable Intake for Magnesium is 350 mg daily. So the product may contain no more than 350 mg per serving.
- The product must be low-sodium. Diets that are high in sodium are associated with Hypertension (High Blood Pressure). Since sodium attracts water, a high sodium diets draws water into the bloodstreams increasing the volume of blood and increasing Blood Pressure.
- The product must not exceed other disqualifying nutrient levels for sodium, cholesterol, saturated fat, or total fat. The exception to this rule is tree nuts which contain about 20% of the daily value of Magnesium per serving but exceed the total fat disqualifying nutrient levels. The FDA believes that since nuts are a nutrient dense food tree nuts can be allowed to use the Magnesium health claim for Low Blood Pressure.
- Prior to any nutrient addition, conventional food products must contain at least 10% of the daily value of Vitamin C, Vitamin A, Iron, Calcium, Fiber and Protein. The FDA has said it will exercise discretion if the food contains 10% of the daily value per service for Potassium or Vitamin D. This requirement does not apply to dietary supplements.
The CRN (Council for Responsible Nutrition) is pleased with this recent decision especially since the original petition was sponsored by the CRN in part.
Let’s talk a little bit about the mineral Magnesium:
Magnesium plays an important role in the structure and the function of the human body. Actually the adult human body contains about 25 grams of Magnesium. Over 60% of the Magnesium in the body is found in the skeleton with about 27% of Magnesium found in the muscles and 6% or 7% of Magnesium found in other cells. As stated above Magnesium, is involved in over 300 essential metabolic reactions including the transport of Calcium and Potassium across cell membranes, protein and nucleic acid (DNA, RNA) synthesis, and energy production. Magnesium is also needed for the normal functioning of muscle and nervous tissue. Due to Magnesium’s interactive role in bone formation with Calcium, it may aid in preventing Calcium deposits as well as the formation of gallstones and kidney stones. Some of the lesser known function of Magnesium are synthesis of certain amino acids, the activation of enzyme systems and the maintenance of RNA and DNA neurotransmitter transmission. A deficiency of Magnesium could cause irritability of muscles and nerves as well as an irregular hearbeat, convulsions and even seizures.
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