Policies and Regulations
It is a widely held myth that modern drugs are dangerous foreign chemicals with
side effects, while herbals are natural, gentle and safe. The truth is that some herbs
can be dangerous and can bring about serious diseases and even lead to death. Un-
like conventional drugs, herbal products are not regulated for purity and potency
and this could cause adverse effects and can even lead to drug interactions
. There are fewer studies on herbal medicines than on conventional drugs,
mainly because, unlike synthetic chemicals, herbs cannot be patented, so there is
little money to be made by funding such research.
It is important that consumers are made aware of interactions herbs might have
with other drugs they are taking. Unfortunately this information is not available
with herbals. Herbals are also frequently adulterated with prescription drugs. In
certain countries, herbal products used for diagnosis, cure, mitigation, treatment,
or prevention of disease are normally treated as drugs, and hence regulated by leg-
islation. However, in most countries, including the United States, such legislation
does not exist and in fact, most botanical products are marketed as dietary supple-
2.10 Policies and Regulations 47
ments. Herbal products categorized as nutritional or dietary supplements are not
regulated [139–142]. In many countries these medicines are not required to pass
any regulatory analysis to be sold as health food supplements.
It is clear that the herbal industry needs to follow strict guidelines and that regu-
lations are needed. The food and drug administrations that regulate prescription
drugs only review a herbal product if the item is suspected of being harmful or if
the label contains a medical claim. Although research is being done, it is very lim-
ited and only a few herbal drugs have been studied adequately by well-controlled
clinical trials. Even though evidence should always be presented to support claims
of products, most herbs are still marketed with little or no research [24, 36, 54, 137,
143, 144]. To be registered as drugs, these products need to be tested to prove their
safety and clinical efficacy. However, so far, few programs have been established to
study the safety and efficacy of herbal medicines as originally proposed in the
WHO guidelines for the assessment of herbal medicines [27, 44, 53, 146, 147].
The future of herbal drugs is overshadowed by the pervading lack of regulatory
control [145, 148–151]. In 1993, the WHO sponsored a symposium on the use of
medicinal plants. The result was a standard guideline for the assessment of herbal
medicines and a recommendation that governments of the world should protect
medicinal plants, improve regulation of herbal medicines, and respect traditional
medicine approaches [50, 91–93, 146, 151–153].
More recently the Health Directorate of Canada developed a new regulatory
framework for natural health products, which came into effect in January 2004.
Among other things, the new regulations call for improved labeling, good manu-
facturing practices, product and site licensing, and provision of a full range of
health claims that will be supported by evidence. However, even in Canada, the on-
ly regulatory requirements enforced are that all products intended for medicinal
use, including natural health products, are issued a Drug Identification Number
(DIN). These numbers are not required for raw materials such as bulk herbs.
In the US, access to herbal medicines is restricted by FDA regulations. Before
any new chemical or herbal drug is approved, research must prove that it is both
safe and effective. As a result of these restrictions, packages of herbal medicines
are labeled as food supplements, which do not require pre-approved testing. Food
supplements cannot make any healing claims or issue warnings about potential
risks. In the US, plant-based derivatives already appear in a quarter of the prescrip-
tion medicines produced. However, many other plants with healing properties are
shunned by the medical community despite scientific data from other countries
showing their effectiveness. The misconception that herbs are old fashioned and
unscientific has helped to promote a general distrust of phytotherapy. The Ameri-
can Botanical Council contends that, in many cases, herbal medicines are safer
than prescription drugs. According to the Council, herbal medicines react more
slowly and often include their own antidotes to counteract any toxic effects [135].
With proper enforcement of regulations, more products that are legitimate will
enter the market and the consumers will see justifiable claims on labels. In fact, it
is predicted that appropriate regulations will rejuvenate the market in response to
growing concerns about the regulatory environment for herbal remedies.
48 2 Quality Control, Screening, Toxicity, and Regulation of Herbal Drugs
It is a widely held myth that modern drugs are dangerous foreign chemicals with
side effects, while herbals are natural, gentle and safe. The truth is that some herbs
can be dangerous and can bring about serious diseases and even lead to death. Un-
like conventional drugs, herbal products are not regulated for purity and potency
and this could cause adverse effects and can even lead to drug interactions
. There are fewer studies on herbal medicines than on conventional drugs,
mainly because, unlike synthetic chemicals, herbs cannot be patented, so there is
little money to be made by funding such research.
It is important that consumers are made aware of interactions herbs might have
with other drugs they are taking. Unfortunately this information is not available
with herbals. Herbals are also frequently adulterated with prescription drugs. In
certain countries, herbal products used for diagnosis, cure, mitigation, treatment,
or prevention of disease are normally treated as drugs, and hence regulated by leg-
islation. However, in most countries, including the United States, such legislation
does not exist and in fact, most botanical products are marketed as dietary supple-
2.10 Policies and Regulations 47
ments. Herbal products categorized as nutritional or dietary supplements are not
regulated [139–142]. In many countries these medicines are not required to pass
any regulatory analysis to be sold as health food supplements.
It is clear that the herbal industry needs to follow strict guidelines and that regu-
lations are needed. The food and drug administrations that regulate prescription
drugs only review a herbal product if the item is suspected of being harmful or if
the label contains a medical claim. Although research is being done, it is very lim-
ited and only a few herbal drugs have been studied adequately by well-controlled
clinical trials. Even though evidence should always be presented to support claims
of products, most herbs are still marketed with little or no research [24, 36, 54, 137,
143, 144]. To be registered as drugs, these products need to be tested to prove their
safety and clinical efficacy. However, so far, few programs have been established to
study the safety and efficacy of herbal medicines as originally proposed in the
WHO guidelines for the assessment of herbal medicines [27, 44, 53, 146, 147].
The future of herbal drugs is overshadowed by the pervading lack of regulatory
control [145, 148–151]. In 1993, the WHO sponsored a symposium on the use of
medicinal plants. The result was a standard guideline for the assessment of herbal
medicines and a recommendation that governments of the world should protect
medicinal plants, improve regulation of herbal medicines, and respect traditional
medicine approaches [50, 91–93, 146, 151–153].
More recently the Health Directorate of Canada developed a new regulatory
framework for natural health products, which came into effect in January 2004.
Among other things, the new regulations call for improved labeling, good manu-
facturing practices, product and site licensing, and provision of a full range of
health claims that will be supported by evidence. However, even in Canada, the on-
ly regulatory requirements enforced are that all products intended for medicinal
use, including natural health products, are issued a Drug Identification Number
(DIN). These numbers are not required for raw materials such as bulk herbs.
In the US, access to herbal medicines is restricted by FDA regulations. Before
any new chemical or herbal drug is approved, research must prove that it is both
safe and effective. As a result of these restrictions, packages of herbal medicines
are labeled as food supplements, which do not require pre-approved testing. Food
supplements cannot make any healing claims or issue warnings about potential
risks. In the US, plant-based derivatives already appear in a quarter of the prescrip-
tion medicines produced. However, many other plants with healing properties are
shunned by the medical community despite scientific data from other countries
showing their effectiveness. The misconception that herbs are old fashioned and
unscientific has helped to promote a general distrust of phytotherapy. The Ameri-
can Botanical Council contends that, in many cases, herbal medicines are safer
than prescription drugs. According to the Council, herbal medicines react more
slowly and often include their own antidotes to counteract any toxic effects [135].
With proper enforcement of regulations, more products that are legitimate will
enter the market and the consumers will see justifiable claims on labels. In fact, it
is predicted that appropriate regulations will rejuvenate the market in response to
growing concerns about the regulatory environment for herbal remedies.
48 2 Quality Control, Screening, Toxicity, and Regulation of Herbal Drugs
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