WASHINGTON, D.C., December 9, 2006 — The U.S. House of Representatives late last night considered and passed Senate bill S3546, the "Dietary Supplement and Nonprescription Drug Consumer Act," which would require manufacturers to notify the Food and Drug Administration (FDA) of all serious adverse events (AEs) for dietary supplements and over-the-counter drugs (OTCs) reported to them. The House passage of the bill follows the Senate’s action of Dec. 6, creating a law that will benefit consumers as well as responsible industry. The bill will now go to President Bush for signature into law. CRN urges the President to sign without delay.
Statement by Steven M. Mister, President and CEO:
"CRN commends Congress on the passage of the adverse events reporting (AER) bill into law. This law is something responsible industry has supported for a long time and we greatly appreciate the hard work of Congress to make it a reality. With this law, consumers can be assured that if they report to a manufacturer a serious adverse event they believe may be associated with a supplement product, that the agency that regulates this industry—FDA—will be made aware of that report. More than 150 million Americans use dietary supplement products and they deserve no less.
"We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements."
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members voluntarily adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.