Tuesday, March 3, 2009

Should the FDA have more regulation over dietary supplements?

Following the release March 2, 2009, by the U.S. Government Accountability Office (GAO) of a report on the oversight and regulation of dietary supplements (FDA Should Take Further Actions to Improve Oversight and Consumer Understanding), 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 principles 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.

"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.

"As we told the GAO, we believe regulations governing the manufacturing of dietary supplements enhance the FDA's ability to ensure the safety and purity of these products. These long-awaited regulations, more than 12 years in the making, were greeted with enthusiasm from industry. Likewise, the industry supported the law establishing mandatory adverse event reporting for dietary supplements. However, we disagree with some aspects of how the FDA has implemented this law. Specifically, we told the GAO the following:

1. The changes to dietary supplement regulation exceed the mandate of the law, especially in regarding to prefatory warning language on product labels.

2. The substantial added expenses to dietary supplement manufacturers to redesign and replace their product labels due to the AER law, upwards of $200 million according to the FDA's own estimates, should have been proposed through a formal rulemaking process, not a guidance. Additionally, the FDA is not allowing adequate time for manufacturers to re-label their products in this case, only one year. Previous regulations of this magnitude have allowed manufacturers a reasonable three years to implement label changes.

We are also concerned about the availability of adverse event reports submitted to the agency and how they will be reported to the public . This has yet to be adequately addressed by the FDA.

"As we have in the past, the association supports adequate funding for the FDA to do its job in regulating dietary supplements. This includes fully implementing the law, DSHEA, and taking appropriate enforcement action against those who break it."

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