Dietary Supplements

Background

More than half of older adults take dietary supplements, in large part because they are viewed as a means to promote and maintain optimal health. However, there is growing concern about the quality, safety, and labeling of supplements. Furthermore, many older adults do not discuss their supplement use with their physician, raising the possibility of dangerous interactions between conventional medicines and supplements. Regulation of dietary supplements is shared between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA does not analyze supplements before they are sold, but it does assess labeling and health-related claims. The FTC is responsible for governing supplement advertising. The substantial growth in Internet marketing of these products—combined with consumers’ (in particular, older adults’) desire for them—has made it challenging for these agencies to stay ahead of some disreputable manufacturers and marketers. Inadequate safety information and false claims on product labels and in advertising remain challenges. It is the manufacturers’ responsibility, not the FDA’s, to ensure the accuracy and truthfulness of their claims. In addition, the mandatory FDA disclaimer statement—that claims by supplement makers “have not been evaluated by the FDA”—is rarely featured prominently on marketers’ websites or packaging.

The Government Accountability Office has repeatedly criticized the regulation of dietary supplements and called for additional Food and Drug Administration authority to oversee supplements and improve consumer understanding of their safety, efficacy, and labeling.

Supplement manufacturers continue to challenge FDA-labeling restrictions in court. The most notable of these cases invalidated FDA-imposed limits on health claims for supplements, thereby allowing the inclusion of “qualified health claims on supplement labels.

Despite these setbacks, federal, state, and private entities continue their efforts to ensure the safety and appropriate labeling of these products. FTC staff regularly challenge claims about the effectiveness of numerous products, including supplements purporting to treat cancer and AIDS.

Health care providers should be encouraged to ask patients about the supplements they take or propose to take as a way to identify possible drug interactions with current medications.

DIETARY SUPPLEMENTS: Policy

Product safety of dietary supplements

In this policy: FederalState

Congress should fund a systematic review of the safety and efficacy of the most common dietary supplements, as outlined in a 2004 Institute of Medicine report, and broaden the authority of the Food and Drug Administration (FDA) to regulate more than just the claims on supplement labels.

Safety information and supplement labels

In this policy: Federal

The FDA should require supplement manufacturers’ labels to include possible supplement interactions with commonly prescribed prescription drugs.