International Diversity and National Policies

The diversity among countries with the long history and holistic approach of herbal medicines
makes evaluating and regulating them very challenging. In addition, there are a great number of
different herbs used. Legislative criteria to establish traditionally used herbal medicines as part of
approved health care therapies faces several difficulties. In a survey conducted across 129 countries,
WHO reported the following issues regarding herbal medicines: lack of research data, appropriate
mechanisms for control of herbal medicines, education and training, expertise within the national
health authorities and control agency, information sharing, safety monitoring, and methods to evaluate
their safety and efficacy. The support needed from different countries includes information
sharing on regulatory issues, workshops on herbal medicines safety monitoring, general guidelines
on research and evaluation of herbal medicines, provision of databases, herbal medicine regulation
workshops, and international meetings.
National policies are the basis for defining the role of traditional medicines in national health
care programs, ensuring that the necessary regulatory and legal mechanisms are established for
promoting and maintaining good practice, assuring the authenticity, safety, and efficacy of traditional
medicines and therapies, and providing equitable access to health care resources and their
resource information (WHO 2005). Another fundamental requirement is harmonization of the market
for herbal medicines for industry, health professionals, and consumers (Mahady 2001). Herbal
medicines are generally sold as food supplements, but a common regulatory framework does not
exist in different countries. As a result, information on clinical indications for their use, efficacy,
and safety are influenced by the traditional experience available in each place. A brief outline of the
legislation in United States, Canada, and Europe is given in this section, and could be used to guide
the legal aspects of the herbal medicine industry in other countries.
In the United States, under the Dietary Supplement Health and Education Act (DSHEA) of
1994, any herb, botanical and natural concentrate, metabolite and constituent of extract, is classified
as a dietary supplement. Dietary supplements do not need approval from the Food and Drug
Administration (FDA) before they are marketed (FDA 2010). Under DSHEA, herbal medicines,
which are classified as dietary supplements, are presumed safe, and the FDA does not have the
authority to require them to be approved for safety and efficacy before they enter the market,
which is the case for drugs. This means that the manufacturer of the herbal medicine is responsible
for determining that the dietary supplements manufactured or distributed are indeed safe and
that any representations or claims made about them are sustained by adequate evidence to show
that they are not false or misleading. However, a dietary supplement manufacturer or distributor
of a supplement with a “new dietary ingredient,” that is, an ingredient that was not marketed
in the United States before October 1994, may be required to go through premarket review for
safety data and other information. Also, all domestic and foreign companies that manufacture
package labels or hold dietary supplements must follow the FDA’s current good manufacturing
practice (GMP) regulations, which outline procedures for ensuring the quality of supplements
intended for sale (FDA 2010; Gao 2010). Regarding contamination, the FDA has not issued any
regulations addressing safe or unsafe levels of contaminants in dietary supplements but has set
certain advisory levels in other foods (FDA 2010; Gao 2010). A product being sold as an herbal
supplement (dietary supplement) in the United States cannot suggest on its label or in any of its
packaging that it can diagnose, treat, prevent, or cure a specific disease or condition without
specific approval from the FDA. A claim also cannot suggest an effect on an abnormal condition
associated with a natural state or process, such as aging (FDA 2010; Gao 2010).
In Canada, herbal remedies must comply with the Natural Health Products Regulations (Health
Canada 2003). According to these regulations, all natural products require a product license before they can be sold in Canada. In order to be granted a license, detailed information on the medicinal
ingredients, source, potency, nonmedicinal ingredients, and recommended use needs to be furnished.
Once a product has been granted a license, it will bear the license number and follow standard
labeling requirements to ensure that consumers can make informed choices. A site license
is also needed for those who manufacture, pack, label, and import herbal medicines. In addition,
GMPs must be employed to ensure product safety and quality. This requires that appropriate standards
and practices regarding the manufacture, storage, handling, and distribution of natural health
products be met. The GMPs are designed to be outcome based, ensuring safe and high-quality products,
while giving the flexibility to implement quality control systems appropriate to the product line
and business. Product license holders are required to monitor all adverse reactions associated with
their product and report serious adverse reactions to the Canadian Department of Health.
In Europe, the European Directive 2004/24/EC released in 2004 by the European Parliament
and by the Council of Europe provides the guidelines for the use of herbal medicines (Calapai
2008). The directive establishes that herbal medicines released on the market need authorization
by the national regulatory authorities of each European country and that these products must
have a recognized level of safety and efficacy (Calapai 2008). The registration of herbal medicinal
products needs sufficient evidence for the medicinal use of the product throughout a period
of at least 30 years in the European Union (EU), at least 15 years within the EU, and 15 years
elsewhere
for products from outside the EU. With regard to the manufacturing of these products
and their quality, products must fulfill the same requirements as applications for a marketing authorization.
Information is based on the availability of modern science–based public monographs in
the European Pharmacopeia and their equivalents developed by the pharmaceutical industry. The
standards put forward allow not only to define the quality of products but also to eliminate harmful
compounds, adulteration, and contamination. Within the EU, a number of committees were
set up to attempt and standardize the information and guidelines related to herbal medicines. A
variety of materials has been produced, such as monographs on herbs and preparations, guidelines
on good agricultural and collection practice for starting materials of herbal origin, and guidelines
on the standardization of applications and setting up pragmatic approaches for identification and
quantitative determination of herbal preparations and their complex compositions (Routledge 2008;
Vlietinck, Pieters, and Apers 2009).