New Dietary Supplement Labeling Act: Responsible legislation or regulatory overkill?

Written by Tara Schomacker, Originally Published by Nutriscience Labs

US Senator Dick Durbin is proposing a bill that will create formal legislation on labeling in an industry that currently manufactures under the regulatory guidance of the FDA. Senator Durbin describes his intent to, “take the decision about how a product will be regulated out of the hands of the manufacturer and put it into the hands of the FDA where it belongs.”

Jonathan Emord of Virginia-based Emord & Associates counters on behalf of the industry, referring to the bill as regulatory overkill. “The FDA has full regulatory power to prevent the sale of adulterated and misbranded foods and dietary supplements.”

“By introducing new powers when old ones are more than sufficient, he invites abuses, including more burden and cost on an industry that is already overwhelmed by the burden and cost of the GMPs and, now, the Food Safety Modernization Act.”

If passed, the bill would require that labels disclose batch numbers, known risks of ingredients and warnings for any potentially serious side effects. Manufacturers would also have to register products with the FDA.

Harry Rice, PhD and Director of Regulatory and Scientific Affairs for the United Natural Products Alliance (UNPA), is suspicious of Senator Durbin’s motives. “The legislation reeks of Senator Durbin’s longstanding opposition to DSHEA and is likely meant to rattle and erode the public’s faith in dietary supplements.”

“Under DSHEA, a company is responsible for determining that the dietary supplement(s) it manufacturers or distributes is safe.”

Michael McGuffin, president of the American Herbal Products Association (AHPA) has been in communication with Senator Durbin’s office and maintains that consumer access to safe dietary supplements will remain AHPA’s primary objective.

References:

Daniells, S. (2011 June 29) Dietary supplement labeling act poised for introduction, industry responds. Retrieved from http://www.nutraingredients-usa.com/Regulation/Dietary-Supplement-Labeling-Act-poised-for-introduction-industry-responds?nocount