Natural Products Association Comments on New GAO Report on Regulation of Dietary S...( Report cites association on GMPs and ...),Health

Report cites association on GMPs and adverse event reporting

WASHINGTON, March 2 /PRNewswire-USNewswire/ -- Following the release today by the U.S. Government Accountability Office (GAO) of a report on the oversight and regulation of dietary supplements, the Natural Products Association (NPA) released the following statement from Executive Director and CEO David Seckman.

"The Natural Products Association appreciates having the opportunity to be included in the GAO's review of dietary supplement regulation, particularly regarding the recent implementation of adverse event reporting and good manufacturing practices. Our initial impressions regarding the four key recommendations of the report are as follows.

"Contrary to opinions stated in the report, the FDA already has a great deal of information about individual dietary supplement products and their manufacturers. The dietary supplement industry has cooperated by registering all manufacturing facilities under bioterrorism regulations that went into effect more than five years ago. Additionally, the NPA is currently working with the government to create a database of all dietary supplement labels to augment this information.

"We also take issue with the implication that the FDA has limited power to remove products from the marketplace. In fact, although the agency has had scant reason to do so, it has exercised its ability to take products off the shelves it deemed a health risk.

"While we supported legislation to establish mandatory adverse event reporting for dietary supplements and over-the-counter drugs, we still believe that reporting should be limited to incidents that are serious. If the FDA's resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense.

"We support further guidance clarifying how t
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