Issue: 69 Page: 4-5
Self-Regulation by the Herb Industry
by Mark Blumenthal
HerbalGram. 2006; 69:4-5 American Botanical Council
Self-Regulation by the Herb Industry
This issue contains a Guest Editorial dealing with the
relative safety of dietary supplements containing bitter orange. Michael
McGuffin, president of American Herbal Products Association (AHPA), the
national trade association of the herb industry, expresses his concerns about
the FDA's releasing of raw data from its adverse event report (AER) database to
members of the media, who, in turn, have published what has turned out to be
erroneous and misleading information on the safety of these supplements.
Articles in the New York Times and later
the Los Angeles Times misreported
that bitter orange has been associated with numerous adverse events, even some
deaths. McGuffin's analysis shows that the FDA's data included many duplicate
reports, plus many AERs related to supplements containing the now-banned and
controversial herb ephedra. We invited officials at the FDA to review the
editorial and provide us any corrections and/or comments, including a possible
rebuttal for publication. After at least six communications with FDA, we have
received no response at press time.
There has been
considerable interest in the level of regulation of herbs and related dietary
supplements. We support the implementation of rational regulations as well as
self-regulation by the industry. Self-regulatory initiatives are usually the
optimal way to regulate any product category and industry, but this requires a
wide degree of voluntary compliance, often difficult to affect. AHPA has taken
leadership in numerous areas of self-regulation, including three "trade
recommendations" that it has recently enacted and/or revised regarding the
presence of heavy metals in some herbal materials, prohibitions against
drug-masking claims, and pesticide/fungicide analysis for cultivated ginseng,
as we report. We also include a story on FDA's recognition of AHPA's
self-regulatory guidelines for establishing common names for herbs used in
commerce, as published in AHPA's book Herbs of Commerce, 2nd edition, which has become federal law as of January 1,
2006.
If it appears that there is a lot of coverage of AHPA and
its work in this issue, with three articles about AHPA initiatives, you're
correct. AHPA has done some laudable self-regulatory work and deserves recognition.
In addition, we were also planning to run an extensive article on new
guidelines by the US Fish and Wildlife Service (FWS) regarding the harvest of
wild American ginseng, issued in August 2005 in accordance with FWS's
responsibilities to monitor threatened and endangered species for CITES (the
Convention on International Trade in Endangered Species of Wild Fauna and
Flora); however, we did not have adequate space for all the regulatory articles
initially slated for this issue.
One of our features profiles some of the historical and
modern literature on jimsonweed (Datura),
a plant with a long but somewhat speckled tradition in folklore, shamanism, and
medicine. Kofi Busia and Fiona Heckels write that this interesting medicinal
plant and its documented psychoactive effects may have some yet unrealized
value for psychiatric medicine, under properly controlled conditionsÑa proposal
that we find interesting and worthy of future research.
|