The Dietary Supplement and Nonprescription Drug Consumer Protection Act, which amends the Food, Drug and Cosmetic Act, was signed into law by President Bush Dec. 22, 2006. The bill requires that companies report to the U.S. Food and Drug Administration all "serious" adverse events for both over-the-counter drugs and dietary supplements. It also requires the FDA to issue notification of reporting requirements within nine months, with the new rules going into effect Dec. 22, 2007.
Companies must print an AER-reporting telephone number on supplements labels and report any calls to the FDA within 15 days.
"Our top priority is providing the products that people want to lead healthier, more fulfilling lives," said David Taylor, president of the Natural Products Association. "So we welcome and support reasonable legislation like this because it will help consumers and the public understand what we have known for some time—that our industry is made up of good people who make good products and stand by them."
The Salt Lake City-based United Natural Products Alliance held a seminar in January to help manufacturers understand the new bill.
Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa, introduced the bipartisan bill.