Botanical Council Calls for Expert Herb Advisory Panel
Group Clarifies Herbal Regulation Issues
American Botanical Council
to the nonprofit American Botanical Council (ABC),
an expert panel of appropriately qualified experts should evaluate
the quality, safety and efficacy of herbal products.
regulation of herbal preparations in the United States is a complex
issue and requires thoughtful analysis, said ABC. The organization
has issued some perspectives on herb regulation in response to an
article in this week's issue of the New England Journal of Medicine
(NEJM) by physicians Donald M. Marcus and Arthur P. Grollman,
one of three herb articles that appeared in the journal.
is understandable that leading physicians would propose changes
in the way herbs are currently regulated," said Mark Blumenthal,
founder and executive director of ABC, referring to one of the articles
published by the NEJM this week. "However, many of the issues
raised in the article and the proposals are not really new, and,
in some cases, may not be feasible."
welcomes the opportunity for a national dialog on improving the
regulatory environment for herbal products," Blumenthal said. "For
many years, ABC has proposed that a special expert committee be
established to evaluate the literature on herbs sold in the U.S.
to determine their safety and benefits. The primary reasons ABC
translated and published The Complete German Commission E Monographs
in 1998 were to offer the public reliable guidelines for the responsible
use of many of the herbs officially recognized as medicines in Germany,
and also to propose a Commission E-like model for the U.S."
in part on testimony provided by ABC, two White House Commissions
have recommended that an independent expert advisory panel be established
to evaluate herbs and related products.
Germany from 1978 to 1995 the Commission E evaluated all the available
scientific literature on over 300 herbs to help determine their
safety and efficacy. The Commission's findings were published as
monographs intended to be used as package inserts for herbal drugs
sold in pharmacies. The Commission, composed of experts in various
fields of herbal science, acts in an advisory capacity to the German
counterpart of the Food and Drug Administration.
the federal Dietary Supplement Health and Education Act of 1994
(DSHEA), herbs are classed as dietary supplements, along with vitamins,
minerals, amino acids and other similar substances. In many other
countries around the world, herbs are regulated as either over-the-counter
(OTC) drugs or as traditional medicines, where the traditionally
used benefits are officially recognized without the herbs having
to meet stringent standards required for pharmaceutical drugs. In
1991 the World Health Organization proposed that herbs be evaluated
for their quality, safety, and efficacy according to standards appropriate
for either OTC drugs or traditional medicines.
health professional groups have expressed dissatisfaction with the
current regulatory system for herbs, partly because herbs are extremely
different from conventional pharmaceutical drugs. Herbs are chemically
complex and are not as amenable to "standardization" as single-chemical
drugs, although many herbal products are standardized to specific
compounds, either as quality assurance measures or to help maintain
a consistent level of activity.
safety of herbs is one of the primary concerns of health professionals,
who claim that the FDA cannot protect the public from unsafe supplements,
citing the DSHEA provision that puts the "burden of proof' on the
FDA to prove a supplement unsafe before it is removed from the market.
However, said Blumenthal, many experts believe that FDA has adequate
authority to protect the public. He cited former FDA Commissioner
Jane Henney, MD, testifying before Congress in 1999, who stated
that "FDA has tools at its disposal to take enforcement actions
against dietary supplements found to have safety, labeling, or other
violations of [federal laws]. . . . I also believe
DSHEA provides FDA with the necessary legal authority to protect
the public health."
the NEJM article calls for herb manufacturers to submit products
for "premarketing approval from FDA" to demonstrate their safety,
Blumenthal noted that under current federal law, all new dietary
ingredients (i.e., herbs and other supplements that are introduced
into the U.S. after October 1994) do require that FDA approve safety
data supplied by the company before a product can be sold.
the current situation, premarket approval on safety and claims for
herbal products is untenable," said Blumenthal. He cited two cases
where an industry group composed of research-based European and
American herb manufacturers petitioned the FDA to approve as over-the-counter
(OTC) drugs the popular herb valerian for night-time sleep aid (in
1994) and ginger for motion sickness and nausea (1995). FDA has
not responded to these petitions.
the potential benefits for a scientific review of the safety and
efficacy of popular herbs, it is clearly not in the interests of
the American consumer for the FDA to take seven to eight years to
review and approve the OTC drug status of herbs when other Western
industrialized nations have already done so," he said. FDA has stated
that it could not respond to such petitions until publicly available
standards were available for herbs that might be approved as drugs,
although the United States Pharmacopeia published such standards
for ginger and valerian several years ago.
NEJM article calls for good manufacturing practices (GMPs)
for herbs, something that many reputable manufacturers and trade
organizations have been wanting from FDA for years, since the passage
of DSHEA. In fact, the proposed GMPs that were published by FDA
in 1997 for public comment were developed with the assistance of
industry experts familiar with the technical aspects of GMPs. For
the past several years FDA has been promising publication of new
GMPs specifically suited for the manufacture of dietary supplements,
but they have yet to be released.
some cases, some of the most popular herbs are also conventional
foods or spices (e.g., garlic, ginger, cayenne pepper, bilberry
or blueberry extract) and some consumer and industry groups may
not want to see these products treated like drugs, especially if
they were to be removed from the market until FDA has approved them,
need rational herb regulation that fits this category," Blumenthal
said, "but we also need the FDA to fully enforce the existing laws
and regulations." He also noted that in the new Canadian regulatory
model herb products are treated under a new regulatory category
as "natural health products" where they will be regulated in a way
that will help ensure their quality, safety and appropriate claims.
"We may want to look North for some possible answers to these issues,"
the American Botanical Council
American Botanical Council is the nation's leading nonprofit organization
addressing research and educational issues regarding herbs and medicinal
plants. The 14-year-old organization occupies a 2.5 acre campus
in Austin, Texas where it publishes HerbalGram, a peer-reviewed
journal on herbal medicine, and will publish in 2003 a book and
continuing education course for healthcare professionals, The
ABC Clinical Guide to Herbs. In 1998 ABC published The Complete
German Commission E Monographs, a 715-page reference book that
was ranked second of all medical books published that year.
Botanical Council (ABC).