DHHS and FDA Release RAND Report on Ephedra and Propose New Warnings
TX, 28 February 2003
Department of Health and Human Services and the Food and Drug Administration
this afternoon released the long-awaited report from the RAND Corporation
on the safety and efficacy of ephedra dietary supplements. The report,
titled, "Ephedra and Ephedrine for Weight Loss and Athletic Performance
Enhancement: Clinical Efficacy and Side Effects" was produced by
an independent scientific and medical committee under the auspices
of the RAND Corporation and is available at www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
also issued a press release "HHS Acts to Reduce Potential Risks
of Dietary Supplements Containing Ephedra" in which the agency explained
that it was proposing regulations on the warnings of the labeling
of ephedra supplements with a 30-day comment public period (www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html).
proposed regulations are on Docket No. 95N-0304, OC 200362: "Dietary
Supplements Containing Ephedrine Alkaloids; Reopening of the Comment
Period." The public comment period closes on April 7, 2003 (available
proposed rules include so-called "black box" warnings, in which
specific warnings are posted in bold in a black box on the primary
label of the product with additional black box warnings to be included
in other labeling literature.
to FDA's release, "To protect Americans from the potentially serious
risks of these dietary supplements, HHS and FDA are going to:
rapid public comment on the new evidence on health risks associated
with ephedra to establish an up-to-date record as quickly as
possible to support new restrictions on ephedra-containing products.
rapid public comment on whether the currently available evidence
and medical literature present a "significant or unreasonable
risk of illness or injury" from dietary supplements containing
rapid comment on a strong new warning label on any ephedra products
that continue to be marketed.
execute a series of actions against ephedra products making
unsubstantiated claims about sports performance enhancement.
a press conference with herb industry associations, FDA's Christine
Lewis Taylor said that the agency had sent warning letters earlier
today to 26 companies who were selling ephedra products for sports
and athletic performance enhancement, a claim the agency does not
consider appropriate or warranted.
addition, HHS Secretary Tommy Thompson and FDA Commissioner Mark
McClellan MD, PhD, issued strong warnings to the American public
on the potential risks associated with using ephedra in strenuous
sports-related activities, in diet programs that stress the cardiovascular
system, when used for extended periods of time, or when used with
caffeine and other stimulants.
want to caution all Americansparticularly athletes and those
who engage in strenuous activitiesabout using dietary supplements
that contain ephedra," said Secretary of Health and Human Services
Tommy G. Thompson. "There continue to be serious questions about
the risks surrounding this particular dietary supplement."
will do all we can to protect Americans from potentially dangerous
dietary supplements," said Commissioner of Food and Drugs Mark B.
McClellan, MD, PhD. "We are particularly concerned about the risks
of using products containing ephedra during heavy workouts, with
caffeine and other stimulants, in a diet program that stresses the
cardiovascular system, or by people under the age of 18. We are
also concerned about potential stresses to the body caused by the
long-term use of ephedra. The standard for regulating the safety
of dietary supplements is largely untested, but we are committed
to finding the right public health solution."
FDA release attempts to summarize the RAND report:
RAND study has concluded that ephedra is associated with higher
risks of mild to moderate side effects such as heart palpitations,
psychiatric and upper gastrointestinal effects, and symptoms of
autonomic hyperactivity such as tremor and insomnia, especially
when it is taken with other stimulants. Moreover, its review of
some 16,000 adverse event reports revealed two deaths, four heart
attacks, nine strokes, one seizure, and five psychiatric cases
involving ephedra in which the records appeared thorough and no
other contributing factors were identified. RAND called such cases
'sentinel events,' because they may indicate a safety problem
but do not prove that ephedra caused the adverse event. The study
recognized that such case studies are a weak form of scientific
evidence. Other unmeasured factors may have contributed, and such
serious adverse events are likely to happen (albeit at very low
rates) among the millions of users of ephedra anyway. The study
also identified other such events potentially associated with
ephedra, in which other factors may have contributed to the adverse
events or in which records were inadequate."
sentinel event is an "early warning to suggest that certain populations
may be susceptible to specific adverse effects," according to Richard
Kingston, PharmD, of Prosar International Poison Center in Minneapolis,
a leading expert in product safety and post-market surveillance.
"Hopefully, this will allow closer scrutiny of these types of events
to search for any cause-effect relationships," he added.
particular additional interest to ABC members is that FDA's Dr.
Taylor said the agency believes it can take appropriate measures
to deal with ephedra under the provisions of DSHEA. However, she
noted that if people think that DSHEA is inadequate, they can submit
comments as to whether legislative initiatives should be taken to
amend DSHEA to deal with ephedra safety. This
appears to be an invitation to various members of the public to
call for Congressional action to modify DSHEA and produce more stringent
legislation to regulate ephedra, and possibly by extension, other
herbal supplements as well.
information on ephedra, including safety issues and recent regulatory
history, is available in ABC's Ephedra monograph from its new book
The ABC Clinical Guide to Herbs, available on the ABC website
Botanical Council (ABC).