On February 2, 2010, Senator John McCain, R-Ariz., introduced legislation that would strengthen the U.S. Food and Drug Administration’s (FDA) oversight of the growing dietary supplement industry. Known as the Dietary Supplement Safety Act of 2010, the bill would usher in sweeping changes to the Federal Food, Drug, and Cosmetic Act (FDCA). Dietary supplement manufacturers and retailers should take heed. Such changes could significantly affect their responsibilities to the FDA, as well as expose them to potential litigation.

After years of claiming it needed greater authority, the FDA would, under the proposed legislation, finally have the power to issue a mandatory recall under various circumstances, including if it found a reasonable probability that a dietary supplement would cause serious, adverse health consequences.

The Act includes a number of changes of which dietary supplement manufacturers should be aware. A few of the highlights include....