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Avoiding Product Liability Traps in the New Dietary Supplement Regime

By Mana Elihu, Christine Kringer and Ray Aragon

A year ago, manufacturers and marketers of dietary supplements benefited when the U.S. Food and Drug Administration (FDA) implemented a new regulation allowing such companies to make unproven health claims on their labels. Under the new relaxed FDA requirements regulating the marketing and promotion of dietary supplements, manufacturers have more leeway to tout the healthfulness of products by making “qualified health claims” on dietary supplement labels, even if there is no “significant scientific agreement” over the validity of these claims. Under the former policy, supplement manufacturers that had scientific support for their claims, but lacked conclusive evidence, were prohibited from marketing their potential health benefits, thus losing out on important marketing opportunities. The new, more flexible dietary supplement regime enables companies to market their products more aggressively and increase sales.

However, while such claims are permitted by FDA guidelines, FDA rules do not serve as a safe harbor to protect manufacturing companies from liability for making overreaching claims. In the midst of an environment in which lawsuits against dietary supplement manufacturers are flourishing, manufacturers must take precautions to avoid exposure. Thus, before publicizing new health claims or benefits of particular products, makers and sellers should become well acquainted with the controlling regulations and incorporate such considerations into their marketing schemes.

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