| Resolution Year 2003
Resolution Number 3:
Dietary Supplements Containing Ephedra
Whereas, in recent years, dietary supplements containing the adrenaline-like, herbal stimulant, ephedra, have been posing difficult public health issues due to accumulating evidence of serious adverse events associated, at times, with their use, and
Whereas, some of these events have included myocardial infarction (heart attack), cerebral vascular incident (stroke), seizure, serious psychiatric illness, and even death, as in the high profile case of the Baltimore Oriole’s 23 year old pitcher who died in February 2003 with a supplement containing ephedra being identified as a contributing factor, and
Whereas, FDA must regulate dietary supplements under the Dietary Supplement Health and Education Act (DSHEA, 1994) which places the burden of proof on the government to first show that the currently available evidence and medical literature supports a finding that use of these products presents “a significant or unreasonable risk of illness or injury”, and
Whereas, in March 2003, FDA reopened its’ comment period on a draft regulation it initially proposed in 1997, and modified in 2000, and is still accepting public comment on such things as:
- new evidence on health risks associated with ephedra,
- whether this evidence supports a finding of a “significant or unreasonable risk of illness or injury”,
- a strong new warning label on any ephedra products that continue to be marketed, and
Whereas, many of the comments received following the 1997 and 2000 draft proposals emphasized the importance of ensuring that consumers were made aware of the risks of consuming dietary supplements containing ephedra and
Whereas, that CASA has expressed strong concern to AFDO regarding the continued use of ephedra in dietary supplements in light of mounting evidence of serious public health consequences, and ask AFDO to concur with this concern and convey it to FDA, and be it further
Resolved, that AFDO formally endorses the new warning statement being proposed by FDA to appear on any ephedra products that continue to be marketed, so that the consumer will be better informed regarding these products. ( A copy of the proposed warning statement is attached below).
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