The U.S. Government Accountability Office (GAO) has recently released a report on the oversight and regulation of dietary supplements, suggesting that the FDA take further steps to improve oversight of the supplements. David Seckman, Executive Director and CEO of the Natural Products Association, the nation’s largest and oldest non-profit organization dedicated to the natural products industry, released the following statement in response to the GAO's findings:
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.
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.
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.
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.
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.
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.”
To have a look at GAO report in its entirety,
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