Re-Regulating Dietary Supplements

Abstract

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be shown to be safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. Instead, the FDA’s authority is generally limited to post-market enforcement under DSHEA. In fact, the FDA lacks the express authority to remove dietary supplements from the market unless it can establish that the products are unsafe, adulterated, mislabeled or misbranded.

Given the morbidity and mortality associated with adulterated dietary supplements and the challenges in addressing the latest fads before they cause harm, Congress must give the FDA the power it needs to be proactive. The FDA desperately needs the tools to regulate the dietary supplement industry and remove harmful dietary supplements from the market. We call on Congress to amend DSHEA to grant the FDA the express statutory authority to (1) regulate dietary supplements prior to entering the market; (2) require manufacturers to submit Supplement Labels to the FDA for pre-market review; (3) require that supplements undergo both pre-market composition testing and post-market randomized composition testing; (4) strengthen agency authority to remove adulterated dietary supplements from the market; and (5) establish an excise tax on dietary supplements.