New FDA Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure
The U.S. Food and Drug Administration (FDA) announced on January 10, 2022, a new qualified health claim for magnesium and reduced risk of high blood pressure (hypertension). The following qualified health claims for conventional foods and dietary supplements are included in the FDA’s letter of enforcement discretion:
- “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.”
With the exception of tree nuts, FDA intends to consider that conventional foods labeled with a magnesium and high blood pressure qualified health claim meet the disqualifying levels for “total fat”, “saturated fat”, “cholesterol”, or “sodium” level as described in 21 CFR 101.14(a). Tree nuts, such as almonds and cashews, that contain approximately 20% of the DV for magnesium per 1 oz serving, would exceed the total fat disqualifying nutrient level, but the FDA intends to provide enforcement discretion from the disqualifying level for “total fat” for tree nuts. The FDA believes that a qualified health claim about the consumption of magnesium from tree nuts could assist consumers in maintaining healthy dietary practices. The FDA reasons that nuts, in general, are nutrient-dense foods that can serve as protein sources and contribute to a healthy US-style eating pattern, as well as the Healthy Vegetarian Dietary Pattern.
Latest FDA Review of a Notification Regarding a Health Claim Related to Peanut Allergies
The U.S. Food and Drug Administration (FDA) undertook a review of a notification in regards of explicit health claims linked to the introduction of certain foods to infants and the reduction in the risk of developing food allergies. In the authorization process of these claims, the FDA took into account statements from the Dietary Guidelines for Americans, 2020-2025.
Manufacturers can use the following claims on the labeling of any food product that may be suitable with the claims:
“If a baby has severe eczema, egg allergy or both, introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”
Manufacturers can use the following claims on the labeling of any food product that may be suitable with the claims:
“If a baby has severe eczema, egg allergy or both, introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”
“For babies with an increased risk of peanut allergy (babies with severe eczema, egg allergy or both), introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.”