DSHEA Provides Strong Framework For Supplement Regulation

- Better Enforcement Needed to Protect Consumers and Industry-

WASHINGTON, D.C., December 18, 2002 - The Council for Responsible Nutrition (CRN) reaffirmed that the Dietary Supplement Health and Education Act (DSHEA) "provides a strong framework for regulating the dietary supplement industry, but full implementation and enforcement would further benefit consumers and industry." CRN, one of the dietary supplement industry's leading trade associations, issued this statement in response to articles in this week's New England Journal of Medicine(NEJM) highlighting concerns about the laws and regulations applicable to botanical dietary supplements.

"It is the responsibility of every company to ensure product quality, to provide accurate and fully informative labeling, to have evidence supporting safety, and to substantiate all claims. A company that fails to fulfill these responsibilities is not only misleading consumers but is engaging in unfair business practices to the detriment of the entire industry," said Annette Dickinson, Ph.D., CRN's Vice President, Scientific & Regulatory Affairs. "Just as importantly, it is the responsibility of the Food and Drug Administration (FDA) to go after those companies that are not complying with the law. We do not need to create new laws or regulations. We need the regulators to reign in companies that are not abiding by DSHEA."

According to a 2002 CRN survey, 75% of American adults are confident in the safety, quality and effectiveness of dietary supplements, with 83% agreeing that vitamin and mineral supplements are safe, and 64% agreeing that herbal [botanical] supplements are safe. Nutrition Business Journal's most recent research indicates approximately 68% of Americans used a dietary supplement in 2001, and approximately 28% used an herbal or botanical supplement.

The CRN survey results show that 94% of consumers trust doctors or other health care professionals for reliable information on supplements. The NEJM article by Peter DeSmet, Pharm.D., Ph.D., was on target in recognizing that consumers value botanical supplements and in concluding, "Clinicians must be informed about the potential effects of herbal preparations and must be able to discuss this subject in a nonjudgmental way. They must tread a line between an apparently sympathetic stance that might be interpreted as an endorsement of unproven therapies and categorical disapproval, which would discourage patients from revealing their use of herbal remedies."

Dr. Dickinson pointed out that DSHEA was passed by Congress in 1994 in large part due to industry efforts backed by strong consumer demand for access to a wide variety of dietary supplement products. She stated, "The articles in the New England Journal of Medicine raise important issues which we believe can be effectively addressed by strengthening implementation of DSHEA."

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