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As a result of the existing
laws and regulations, most herbal remedies (botanicals, phytomedicines)
are currently marketed in the United States as dietary supplements, a food
category, not as the drugs they are. This situation stems directly from
the passage, in 1962, of the Kefauver-Harris Amendments to the Federal
Food, Drug, and Cosmetic Act of 1938. These amendments required drugs to
be proven effective prior to marketing, in addition to the purity and
safety requirements already in effect.
Although the law
specifically exempted from this requirement all drugs marketed prior to
1938, which included almost all of the herbal remedies, the Food and Drug
Administration (FDA), by a clever application of administrative law, i.e.,
regulations, circumvented the will of Congress. The agency declared that
although sale could continue, any unproven claim of efficacy would cause
the herb to be considered as misbranded which could result in
confiscation.
To determine efficacy of
over-the-counter products, in 1972 the FDA established 17 panels to
evaluate, on the basis of submitted information only, the data supporting
such claims. The panels were not permitted to utilize anecdotal
information, product popularity, nor did they conduct detailed literature
surveys. Because proof of efficacy studies are extremely expensive-current
estimates for new chemical entities range up to one-half billion dollars-a
limited amount of data was submitted to the panels for the old botanical
remedies for which patent protection and market exclusivity with
consequent profitability were doubtful.
In consequence, very few
herbal remedies were approved as drugs. The few that were found acceptable
included capsicum (Capsicum spp.) as a topical analgesic, slippery elm (Ulmus
rubra Muhl.) as a demulcent, psyllium seed and husk (Plantago spp.) as a
laxative, and distilled extract of witch hazel (Hamamelis virginiana L.)
as an astringent (due to the 14% alcohol added to the final preparation).
On the basis of inadequate data submission, the FDA declared peppermint (Mentha
× piperita L.) to be an unsafe and ineffective digestive aid and placed
other useful remedies such as the antitussive eucalyptus (Eucalyptus
globulus Labill.) and the laxative prune (Prunus domestica L.) concentrate
in the same category.
Sales of such herbal
products declined for a time but began to increase once again in the 1980s
as consumers became more health conscious and displayed a significant
interest in natural products. Finally in 1993, Commissioner David Kessler
of the FDA threatened additional controls on such products. The public
rebelled, and submitting to the will of the people, Congress passed the
Dietary Supplement Health and Education Act of 1994. That Act permits any
herb sold in the United States prior to October 1994 to continue to be
marketed as a dietary supplement (food) without FDA approval.
Labeling of such products
is, however, restricted. Therapeutic claims are not permitted. This
prompts the potential user to turn to the herbal literature, much of which
is hyperbolic and advocacy in nature-especially on the internet-designed
to promote sale of the product. Claims regarding the effect of the remedy
on the structure or function of the human body are permitted on the label,
but such a statement must be followed by another indicating the claim has
not been approved by the FDA. A third statement must then follow
indicating the product is not intended to diagnose, treat, cure, or
prevent any disease. That, of course, is why the potential user wanted to
purchase the product in the first place, so the entire situation becomes
very confusing, even to the sophisticated consumer.
Another serious problem
with the herbal product status quo is the total lack of quality standards
for such preparations. Products and the companies selling them range from
very bad to very good. Consumers have few resources to determine which is
which, and published analyses of particular brands have been quite
limited, probably due to the fear of litigation.
Other advanced nations have
solved the herbal problem in one of two ways. The first is simply to allow
botanicals to be sold as "traditional" drugs whose efficacy is
based on long usage and anecdotal information, not on scientific or
clinical studies. This is not a satisfactory solution because many of such
claims of utility remain unverified.
The best solution, without
question, is to modify existing regulations to allow herbal remedies to be
sold as drugs, with appropriate quality standards, following absolute
proof of safety and "reasonable" proof of efficacy. The
reasonable qualification would allow the marketing of a product with a
research investment of perhaps a few million dollars as opposed to the
hundreds of millions now required. Such an expenditure is just a small
fraction of the marketing budget of many herbal product manufacturers.
This type of drug approval
is the one that exists today in Germany. It has functioned well there for
decades, and no serious problems have been encountered. Safety and
efficacy are determined by an independent panel of experts, designated
Commission E, appointed by the German equivalent of our FDA. The
Presidential Commission on Dietary Supplement Labels recommended the
appointment of a similar panel in the United States to evaluate herbal
safety and efficacy. So far, the FDA has not acted upon that
recommendation nor has the agency given any indication that it will do so.
Likewise, the FDA has not acted upon a long-standing petition that would
allow the safety and utility of herbs to be evaluated as OTC remedies on
the basis of the voluminous scientific and clinical studies already
carried out in European countries, especially Germany.
Adherence to standards for
drug approval designed for new synthetic chemical entities is obviously
not realistic for long-used herbal remedies. In view of the fact that
one-third of the adult population in this country now employs herbal
remedies and the retail market approximates $4 billion annually, serious
consideration needs to be given to modifying outdated regulations. A
change is urgently required to assure that consumers will be supplied with
quality products providing appropriate information regarding their
therapeutic utility directly on the label.
Among the numerous
botanicals marketed in the United States today are several that produce
significant direct or indirect effects on the central nervous system. Some
of the more prominent ones have been extensively studied with respect to
their chemical composition and physiological and therapeutic activities.
Others continue to be employed largely on the basis of their folkloric
reputations as useful remedies.
Source:
Purdue Univ. [Excerpts taken from: Varro E. Tyler] |