—Proposed Legislation Would Benefit Consumers and Business—
WASHINGTON, D.C., June 21, 2006 — The Council for Responsible Nutrition (CRN) today commended Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.) for introducing S. 3546, “Dietary Supplement and Nonprescription Drug Consumer Act,” a bill that would require manufacturers to notify FDA of all serious adverse events (AEs) for dietary supplements and over-the-counter drugs (OTCs) reported to them.
CRN has long supported the concept of mandatory reporting for serious adverse events, calling it “the right thing for a responsible industry to do.” According to CRN President and CEO Steve Mister, “This bill does two things. First, it demonstrates a commitment to consumers by ensuring that the agency that regulates the supplement industry is informed of any serious problems associated with our products. As importantly, it also includes appropriate protections to help ensure that unjustified burdens are not placed on responsible companies.”
CRN further commended the Senators for their bi-partisan leadership and their willingness to invite the industry, along with consumer groups and regulators, to have input in the process, thereby recognizing that the best way to protect consumers is to set up a system that is workable for everyone.
“This bill is another demonstration that the supplement industry is, in fact, regulated and that companies are committed to making regulation work. If a consumer contacts a company with a concern that she suffered a serious injury or hospitalization and believes the event is associated with use of one of our products, she has a right to expect that the complaint will be shared with the regulatory agency that oversees the industry—in our case, FDA,” said Mr. Mister. “We look forward to the expedient consideration and passage of this bill in the Senate and encourage the House of Representatives to take similar steps.”
The bill is expected to be reviewed in the Health, Education, Labor and Pensions (HELP) Committee before the end of June.
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 adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.
Additional materials are available on CRN's website: http://www.crnusa.org/AERbill0606.html