Supplementing Dietary Supplement Regulation

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Experts recommend measures to improve the regulation of dietary supplements.

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Walk through any drugstore and you are sure to see pills, tablets, and powders boasting a wide array of health benefits. Workout powders and weight loss pills promise your dream body. Tubs of vitamins promise to improve your memory, ease your anxiety, and boost your energy—sometimes all at once.

Dietary supplements include over-the-counter amino acids, hormones, minerals, plant and animal extracts, and vitamins. In just 25 years, the market for dietary supplements has grown rapidly, with every four in five U.S. adults now claiming to use these supplements.

But with a growing market comes growing risk, and adverse health events associated with dietary supplements are all too common. In a recent article, experts contend that consumer protection regulations have failed to keep pace with the rapid expansion of the dietary supplement market.

These experts—Elizabeth Richardson, Farzana Akkas, and Amy B. Cadwallader, writing in the AMA Journal of Ethics—evaluate potential reforms to strengthen regulatory efficacy and mitigate public health risks.

The U.S. Food and Drug Administration (FDA) is tasked with regulating the safety of dietary supplements, but Richardson, Akkas, and Cadwallader contend that statutory limitations and loopholes hinder the agency’s ability to do so effectively.

Unlike when it regulates drugs or medical devices, FDA does not hold authority to regulate the efficacy of dietary products, only to regulate their safety. As a result, FDA inspections of manufacturing plants show consistent use of inaccurate labeling of dietary supplements, with marketing claims often failing to align with experimental findings, note Richardson, Akkas, and Cadwallader.

Under current regulations, dietary supplements cannot be advertised to treat or prevent disease, but they can be marketed to describe how a particular ingredient impacts the body. And manufacturers are not required to submit any evidence to FDA to substantiate these claims.

Richardson, Akkas, and Cadwallader find that, due to the lack of evidentiary requirements for product labeling, many dietary supplements are backed by minimal or entirely nonexistent evidence supporting the health benefits of their use. This discrepancy can be dangerous to consumers who may be easily misled by unsubstantiated claims of supposed bodily benefits.

Richardson, Akkas, and Cadwallader argue that, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is left with “no clear view of what’s on the market at any given time.” They note that DSHEA does not empower FDA to conduct premarket review of dietary supplements. Instead, the law allows manufacturers to sell their products without first providing the agency with any basic information—not even the products’ names or ingredients.

Richardson, Akkas, and Cadwallader explain that this lack of pre-market information leaves FDA to rely entirely on post-market surveillance methods to evaluate the safety of these supplements. And, before the agency can ban or recall a product, it bears the burden of proving that the product is unsafe.

Meeting this burden takes time. Richardson, Akkas, and Cadwallader discovered it took FDA seven years to ban ephedra from dietary supplements, even though this ingredient increased individuals’ risk of stroke and death. Delays like this only put consumers at risk, as they may unknowingly serve as the experimental pool of users necessary for FDA to prove a product is unsafe before instituting a mandatory recall.

Richardson, Akkas, and Cadwallader point to what they see as another weakness in FDA’s oversight of dietary supplements: the “generally recognized as safe” (GRAS) exemption for food products which allows manufacturers merely to “self-affirm” the safety of dietary supplement ingredients. The GRAS exemption has allowed many manufacturers to avoid even the minimal requirements to notify FDA of supplements with novel ingredients.

In response to these concerns, Richardson, Akkas, and Cadwallader consider reform initiatives put forth by public health and consumer advocacy organizations.

The least controversial reform proposal is a transparency measure, currently supported by the House Appropriations Committee and 95 percent of U.S. adults. This proposal would require manufacturers to inform FDA of the ingredients contained in their products and provide a copy of the product’s label. Richardson, Akkas, and Cadwallader contend that this proposal would provide FDA with a more comprehensive understanding of the market and make it easier for the agency to recall products containing harmful ingredients.

In addition, Richardson, Akkas, and Cadwallader maintain that FDA could increase the stringency of “current good manufacturing practice” regulations and ensure that manufacturers remain cognizant of these standards and of any associated developments. Richardson, Akkas, and Cadwallader posit that these updated regulations could include quality control measures to define the required purity and strength of dietary supplements.

To prevent firms from exploiting the GRAS exemption, Richardson, Akkas, and Cadwallader recommend that Congress pass legislation to exclude dietary supplements from the “food products” this exemption covers or that FDA expand its new dietary ingredient notification pathway guidance to include dietary supplements that would otherwise secure a GRAS designation.

In response to increasing calls for reform, Congress is currently contemplating legislation to enhance FDA’s authority to regulate dietary supplements. In the meantime, however, Richardson, Akkas, and Cadwallader suggest healthcare practitioners actively inform patients of supplement safety concerns to create a more knowledgeable consumer base.