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 the FDA determines when an ingredient is considered 'new' to the marketplace and what evidence is needed to document safety. Likewise, we are in favor of the agency clarifying when it believes products should be marketed as conventional foods versus dietary supplements.
"One of the fundamental principals of DSHEA [Dietary Supplement Health and Education Act of 1994] is providing consumers with more information so that they can make informed decisions to maintain and improve their health. So we are in agreement that the FDA should work with stakeholder groups to educate consumers about the safety, efficacy and labeling of dietary supplements.
"Finally, there is little scientific data regarding underreporting of adverse events and the data that are cited are not specific to dietary supplements, but represent all FDA-regulated products, including pharmaceuticals, a category that accounts for more than 460,000 reports annually."
About The Natural Products Association
The Natural Products Association is the nation's largest and oldest non-profit organization dedicated to the natural products industry. The association represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Association members meet annually each July in Las Vegas at the association's official tradeshow, Natural MarketPlace (http://www.naturalmarketplaceshow.com/).
|SOURCE Natural Products Association|
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