Thesis: There needs to be
regulation of herbal remedies and dietary supplements from an
outside source that is not interested in the monetary benefits
from the herbal market. Although herbal remedies and dietary supplements
can be beneficial to many Americans, the United States needs to
implement
an administration to analyze, research, and regulate what herbs
are in supplements, and their acceptable uses.
Outline:
I. Introduction
A. China example
B. Ephedrine example
II. History of Herbal Remedies
A. China
B. Europe
C. Garlic example
III. Current Management
A. Europe- Germany
B. United States
i. Dietary Health and Education Act of 1994
IV. Future Management
A. FDA 10 Year plan
V. Conclusions
Herbal supplements and herbal treatments
are nothing new to people looking for a way to enhance their diets
or to those trying to find an alternative to traditional drugs.
Such supplements include vitamins or minerals already present
in the majority of foods. Other treatments are more unusual and
stem from ancient Chinese healing or Native American therapies.
Often these additional or alternative treatments have a positive
effect on the patient. In China, during the early seventies, there
were good results reported for treating bronchopneumonia in children.
The doctors used herbal medicines, traditional methods of massage
along the spinal column, and acupuncture and injections into needling
points in conjunction with current antibiotics. This combination
of traditional medicine with current medical practices had major
improvements over the simple administration of antibiotics since
the most recent method of antibiotics did not take into account
the problems of a poor functioning cardiovascular system, spasms
of the bronchi, and the fact that asthma often continues. The
traditional method does have an effect on these symptoms (Risse, 108). However, despite the positive effects,
there have been reported instances where men and women have been
seriously injured or even killed from the effects of an herbal
supplement. According to an article from CNN interactive there
have been 17 reported deaths and 800 illnesses from ephedrine-laced
herbal supplements. Ephedrine, an herbal stimulant that can be
put into any dietary supplement, is like an amphetamine. It has
the effect of stimulating the heart and nervous system and the
FDA states the evidence that the herbs can cause heart attack,
stroke and death (Cohen, 2).
With these conflicting reports it is
difficult for a consumer to make an educated decision when choosing
if or what herbal supplement to purchase. There is little information
available to consumers in the United States that has come from
an impartial third party. Rather, the majority of information
is made available from manufacturers. There needs to be regulation
from an outside source that is not interested in the monetary
benefits from the herbal market. Although herbal remedies and
dietary supplements can be beneficial to many Americans, the United
States needs to implement a program to analyze, research, and
regulate what herbs are in supplements, and their acceptable use.
Herbs and alternative treatments have
been used for centuries in different cultures as medicine and
in religious practices. In ancient China traditional medicine
was a compilation of centuries of knowledge. However, "Öprofessional
jealousy and competition resulted in little sharing of empirical
knowledge gained by practitioners who saved it to pass on to a
few selected apprentices or to keep it within the family"
(Risse, 107). But, by the mid 1950s, the
Chinese government made a commitment to the whole scale
acceptance and study of traditional Chinese medicine. They began
requiring modern doctors to study a certain amount of traditional
medicine along with modern medical methods. This commitment has
led to a wider understanding of the mechanisms and effects that
the traditional medicaments had on the human body as well as bringing
the herbal remedies to the Western world.
Herbs were not unknown to Europe and
Great Britain during the Middle Ages. The herbs and spices were
not only used for medicinal purposes, but also for cooking by
adding flavoring to foods. According to historian Agnes Arber,
a monk named Bartholamaeus Anglicus printed one of the first known
recordings on the healing properties of herbs. In his encyclopedia,
Liber de Proprietatibus Rerum, printed in about 1470, a large
section consists of many trees and herbs and is chiefly occupied
with their medicinal properties. This book has persisted into
the 20th century and has provided an irreplaceable background
to many of the now famous herbal remedies.
One such example of a natural herb that was
revered for its medicinal and culinary properties is garlic. Garlic
was well known to ancient and medieval civilizations and widely
appreciated. Garlic is a member of the lily family and it is among
the oldest cultivated plants in all existence. Garlic's precise
origin predates written history since it has been used in folk
medicine for thousands of years. In ancient times when remedies
had to be formed of natural sources, anything pungent and strong
was considered to have great power. In the Codex Ebers, an Egyptian
medical papyrus dating about 1550 B.C., of the more than 800 therapeutically
formulas, 22 mention garlic for a variety of ailments including
heart problems, headaches, bites, worms, and tumors (Steiner,
126). Aristotle, Hippocrates, and Aristophanes recommended
garlic for its medicinal effect. During the first Olympic games
in Greece, the athletes were said to have employed garlic as a
stimulant. More recent clinical studies suggest that garlic is
a vasodilator (dilates blood vessels) and that both garlic and
onions are anticoagulants (prevents blood from clotting) (Steiner, 128).
Most of the herbs that are now marketed
in the United States, including garlic, have roots from ancient
China, Native American traditions, or sources such as Angelicus'
encyclopedia from the European Middle Ages. This mixing of traditional
treatments can be confusing to consumers and health care professionals.
The United States has done little to research the background and
mechanisms of the most common herbal supplements found in grocery
stores and health food chain stores.
Currently, many European countries have
established national associations that are dedicated solely to
the investigation and analysis of popular herbal supplements.
In 1978, Germany's Federal Health Agency established Commission
E to evaluate some 1,400 herbal drugs corresponding to 600-700
different plant species. In that country approval of herbal drugs
is based on the results of clinical and pharmacological studies.
In contrast, France and the United Kingdom consider the traditional
use of herbal drugs to generally be considered as sufficient proof
of the product's efficacy and safety. In Germany, the required
amount of research needed to prove an herb's safety is much less
than it would be in the United States. The German standard has
been characterized as providing "reasonable certainty"
rather than "absolute proof" of safety and efficacy
(Tyler, 1). Much of the research in Germany
is conducted in-house by pharmaceutical companies, but much is
also carried out under grants and contracts by institutes or departments
of universities. Germany leads the world in phytomedicinal research
stating that once a product has been proven safe, only reasonable
certainty is required to market it there (Tyler,
2).
Dietary Health and Education Act of 1994:
Western Europe's successful experience
with phytomedicines has had little impact on herbal remedies in
the United States. In 1994 the U.S. Food and Drug Administration
initiated a Dietary Supplement Health and Education Act. This
new act was a new amendment to the 1958 Food Additive Amendment
to the Federal Food, Drug, and Cosmetic Act. Under the previous
guidelines dietary ingredients used in dietary supplements were
considered to be under the same regulations as food products.
However, under the DSHEA of 1994, these ingredients are no longer
subject to the premarket safety evaluations required of other
new food ingredients (FDA 1995). The DSHEA
acknowledges that millions of American consumers believe that
dietary supplements may help augment daily nutritional intake
as well as provide additional health benefits. "Congress'
intent in enacting the DSHEA was to meet the concerns of consumers
and manufacturers to help ensure that safe and appropriate labeled
products remain available to those who want to use them"
(FDA 1995).
The FDA has traditionally considered
dietary supplements to be composed of only essential nutrients
such as vitamins, minerals or proteins. However, a Nutrition Labeling
and Education Act of 1990 effectively added "herbs or similar
nutrient substances" to the term dietary supplement. The
definition of a dietary supplement is considered by using the
following criteria: a product that is intended to supplement the
diet and contains one or more of the above dietary ingredients,
is intended for ingestion in pill, capsule, tablet, or liquid
form, is not represented for use as a conventional food or as
the sole item of a meal or a diet, and is labeled "dietary
supplement" (FDA 1995).
The manufacturer of the herbal supplement
is responsible for making sure that all the dietary ingredients
in the supplement are safe. Manufacturers and distributors do
not need to register with the FDA or get FDA approval before producing
or selling dietary supplements (FDA 1997).
This indicates that the FDA does not keep a list of manufacturers
or products on the market. The reason given behind this policy
is that the FDA has limited resources to analyze the compositions
of food products, including dietary supplements. So, the FDA focuses
on public health emergencies and products that may have caused
injury or illnesses. Thus, the FDA does not analyze supplement
products before they are sold to consumers. The manufacturers
are responsible for ensuring that the ingredients list is accurate
and the ingredients are safe. They are also required to make sure
that the content matches the amount declared on the label.
According to an article in Health, because of the FDA's limited
resources, just three staffers monitor adverse reactions from
herbal pills or tinctures. By contrast, 10 people track how many
animals get sick for veterinary drugs. According to Ilene
Rigel Heller, an attorney for the Center for Science in the Public
Interest, "The FDA is basically forced to regulate by press
release" (1).
In order to control manufacturing, the
DSHEA has mandated that only specific statements may appear on
the label of dietary supplements. The manufacturer may make a
claim linking well-known health claims, such as the claim linking
folic acid deficiency and neural tube defects, but the product
cannot carry the claim that it cures cancer or treats arthritis.
Manufacturers may also make statements to the supplements effects
on structure or function of the body. But, in order to use these
claims, the manufacturer must have substantiated that the statements
are truthful and not misleading and the product label must include
the warning "This statement has not been evaluated by the
Food and Drug Administration. This product is not intended to
diagnose, treat, cure, or prevent any disease" (FDA
1995). However, nutritional support statements do not need
to be approved by the FDA before manufactures can market a product.
Additionally, if an herbal company desires to market a new ingredient,
it has two options. First, it must submit information that supports
their conclusion that a new ingredient can be reasonably expected
to be safe to the FDA at least 75 days before the product is expected
to arrive on the market. In essence, they must provide proof that
the new ingredient does not present a significant or unreasonable
risk of illness or injury under conditions of use recommended
on the product label. A second option available to manufactures
is to petition FDA, asking the agency to establish the conditions
under which the new dietary ingredient would be reasonably expected
to be safe. To date, FDA's Center for Food Safety and Applied
Nutrition has received no such petitions (FDA
1999). To this point, it appears that the great majority
of herbs and dietary supplements are being provided to the public
without the intervention by a third party. However, there are
strategies in the future that may help with this current problem.
In January of 2000, the U.S. Food
and Drug Administration released its Dietary Supplement Strategy
in the form of a 10-year plan. The purpose behind this new committee
is to "develop an overall strategy for achieving effective
regulation of dietary supplements under the Dietary Supplement
Health and Education Act of 1994" (FDA 2000).
In June of 1999, the FDA developed five internal dietary supplement
teams: safety, labeling, boundaries, enforcement, and research.
The FDA has mandated that they will develop, on an annual basis,
specific items that are to be accomplished each year during this
10-year term. The goal of the overall strategy is, "by
the year 2010, [to] have a science-based regulatory program that
fully implements the Dietary Supplement Health and Education Act
of 1994, thereby providing consumers with a high level of confidence
in the safety, composition, and labeling of dietary supplement
products" (FDA 2000). The FDA proposes
to implement their new plan through several channels. Among other
things, they will institute an efficient system for the monitoring,
clinically evaluating, and timely regulatory follow-up of significant
event reports. They also plan to educate consumers and health
care workers on how to use the newly instated adverse event reporting
system. Screening of new dietary supplements will remain at 75
days prior to public release, however an Internet surveillance
program will be implemented in order to monitor whether products
are being marketed for safe uses. The FDA will publish clarifications
between dietary supplements, drugs, and foods. They also
plan to ensure a sound science-based program for all dietary supplement
review and to develop a core of well-trained, multidisciplinary
scientists in support of supplement review and research. All of
these new protocols, as well as others not mentioned would add
to the development of mechanisms to communicate dietary supplement
information to the general public and to health care professionals.
The use of herbs as dietary supplements and alternative
medicines has a long history throughout many cultures around the
world. Although they are often met with disinterest and disbelief
dietary supplements have become a billion dollar business. The
Dietary Supplement Health and Education Act of 1994 was established
in the United States in order to ensure that those in the public
who whished to supplement their diets with herbs for nutritional
or medicinal purposes could have access to such supplements. However,
marketing without adequate research from an impartial third party
has lead to deaths and injuries/illnesses from various dietary
supplements containing herbs. The U.S. Food and Drug Administration
implemented a 10-year plan in January of 2000 in order to address
the problems of safety testing and proper labeling of herbal supplements.
It is the hope of the government and those interested in herbal
and dietary supplements that these new implementations will lead
to the safe marketing and use of herbal remedies in the future.
Works Cited
Arber, Agnes. Herbals: Their Origin and Evolution. Cambridge University Press. Cambridge, 1938.
Cohen, Elizabeth. "FDA Wants Warning Labels for Some Herbal Supplements." June 3, 1997. <http://www.cnn.com/HEALTH/9706/02/nfm.supplement/>
"Herbs: FDA is MIA". Health. May, 2000, Vol. 14:24.
Kurtzweil, Paula. An FDA Guide to Dietary
Supplements. January 1999.
<http://vm.cfsan.fda.gov/~dms/fdsupp.html>
Risse, Guenter. Modern China and Traditional Chinese Medicine: A Symposium Held at the University of Wisconsin, Madison. Springfield, IL. 1973.
Steiner, Richard. Folk Medicine: The Art and the Science. American Chemical Society. Washington, DC. 1986.
Tyler, Varro. "Should Herbal Remedies Remain in FDA Regulatory Limbo?". Nutrition Forum. Nov/Dec 92, Vol. 9, Issue 6, p41.
U.S. Food and Drug Administration. "Overview of Dietary Supplements". May, 1997. <http://vm.cfsan.fda.gov/~dms/ds-oview.html>
U.S. Food and Drug Administration. "Dietary
Supplement Health and Education Act of 1994". December 1,
1995.
<http://vm.cfsan.fda.gov/~dms/dietsupp.html>
U.S. Food and Drug Administration. "Dietary
Supplement Strategy: Ten Year Plan". January 2000.
<http://vm.cfsan.fda.gov/~dms/ds-strat.html>