The drug approval process of the US Food and Drug Administration (FDA) has evolved into the world’s gold standard for ensuring that drugs introduced to the public are safe and effective for their intended use. One important and often overlooked part of the FDA’s approval process by health care professionals is that of manufacturing. The FDA ensures, through premarket approval standards, that drugs contain the labeled amount of active pharmaceutical ingredient, even if the product is generic. Unfortunately, the same cannot be said about products that do not undergo premarket review, such as dietary supplements. Dietary supplements are regulated separately from drugs under the regulatory framework created by the Dietary Supplement Health and Education Act of 1994. The Dietary Supplement Health and Education Act of 1994 allows dietary supplements to forgo premarket review by the FDA, instead initially relying on dietary supplement manufacturers’ compliance with FDA regulation and guidance. Given the lack of premarket review, dietary supplement manufacturers should follow dietary supplement current good manufacturing practices (cGMPs), as required. Through cGMP, the FDA can ensure the identity, strength, quality, and purity of dietary supplements through adequate regulation of manufacturing operations and processes. Compliance with cGMP could ultimately attenuate concern about the differences between dietary supplement labeling and container content. Unfortunately, dietary supplements have been riddled with cGMP noncompliance. Problems found in cGMP inspections of dietary supplement manufacturers are reported in a majority of inspections, lending little credence to the notion of safety and compliance without premarket review.1 Health care providers and the public may expect the label of dietary supplements to reflect the contents of the container, but a recent study by LeBlanc et al2 has defied those expectations and points to a potential serious public health concern.
Madden MM, Cook GE. Dietary Supplementation in Children and Adolescents: Supplementing With the “Correct” Amount. JAMA Pediatr. 2013;167(11):991–992. doi:10.1001/jamapediatrics.2013.2908
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