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Volume XIII, Number 35

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FDA Announces New Qualified Health Claim

  • On January 10, 2022, FDA announced in a letter of enforcement discretion a new qualified health claim for magnesium and reduced risk of high blood pressure.

  • Both health claims and qualified health claims characterize the relationship between a substance and a reduction in risk of contracting a particular disease or health related condition and are reviewed by FDA through a petition process. Qualified health claims are supported by less evidence than the “significant scientific agreement” standard that governs unqualified health claims. Therefore, qualified health claims require a disclaimer or other qualifying language to avoid misleading consumers as to the strength of the scientific evidence supporting the claim.

  • FDA found some credible but inconclusive evidence suggesting a relationship between the intake of elemental magnesium from conventional foods and dietary supplements and reduced risk of high blood pressure. Accordingly, the Agency will exercise its enforcement discretion for the following qualified health claims for conventional foods and dietary supplements:

    • “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.”

  • Foods and dietary supplements making these claims must be “high” in magnesium as defined in 21 CFR 101.54(b) (i.e., must contain at least 84 mg of magnesium per RACC) and must meet all the other general requirements regarding health claims set forth in 21 CFR 101.14, except that tree nuts are exempt from the disqualifying level for total fat provided that the label bears the disclosure “see nutrition information for fat content.” Furthermore, dietary supplements bearing these claims should not provide more than 350 mg magnesium when used according to their labeling instructions. For more information regarding qualified health claims, see FDA’s guidance page.

© 2023 Keller and Heckman LLPNational Law Review, Volume XII, Number 11
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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