Page 64 - FoodFocusThailand No.195 June 2022

STRATEGIC R & D

The Use of Unlike pharmaceutical drugs, which must go through clinical trials,
Herbal Products traditional medicine manufacturers can solely rely on a long history
The belief that herbal of use.
therapy will promote • The American standards The regulatory requirements for
better health and herbal medicinal products in the United States are less stringent.
healthier living is the primary Herbal products in the United States are generally regulated as dietary
reason many people in supplements, which means lower standards. Manufacturers are not
developed countries are required to test their herbal products' biological and chemical
interested in it. Consequently, properties, nor are they required to register them with the Food and
herbal medicines are frequently Drug Administration (FDA). However, herb sellers are only permitted
regarded as a balanced and to make limited health claims, and it is illegal to imply that any herbal
reasonable approach to healing. It product prevents disease. US manufacturers are also responsible
is also found that the large number for ensuring that the information on the herbal product label is accurate
of consumers who usually buy and not misleading. Meanwhile, the FDA monitors them along with
nonprescription drugs or over-the- reports of dietary supplement side effects.
counter medicines also spend a lot on
herbal products, which explains why the Quality Assurance of Herbal Medicinal Products
sale of herbal medicines is increasing Manufacturers and regulatory bodies share responsibilities for quality
and becoming a sizable share of the assurance of herbal medicinal products. National drug regulatory
global pharmaceutical market. bodies must create rules for all aspects of quality assurance, analyze
As the global use of herbal remedies documentation and data given by manufacturers, and monitor post-
grows and more new products enter the marketing conformity of herbal products based on manufacturer
market, related-health issues and concerns specifications and Good Manufacturing Practices (GMP). On the
about their safety are becoming more other hand, manufacturers are required to follow standards such
prevalent. Although some herbal medicines have as Good Agricultural and Collection Practices (GACP), Good
promising potential and are widely used, many of Manufacturing Practices (GMP), and Good Laboratory Practices
them have yet to be tested and monitored for (GLP). They must develop appropriate specifications for their
efficacy and safety after use. It is also generally products, intermediates, and starting materials. It is also their
accepted that the safety of most herbal products is responsibility to compile comprehensive documentation on
negligible and could be jeopardized by a lack of pharmaceutical development and testing. Additionally, every producer
proper quality controls, inadequate labeling, should continue to improve their own standards and adapt them to
and an absence of adequate patient current knowledge. Collaboration between manufacturers and the
information. As a result, it is critical to provide sharing of drug quality control information should also be encouraged
sufficient information to the public and to enhance industry standards.
healthcare professionals to understand better the There are different types and forms of herbs, each with its own
risks associated with the use of herbal products to ensure their set of benefits and drawbacks if misused or consumed in an
safety and appropriate use. inappropriate amount. Researching related studies and learning the
rules and regulations governing the use of herbs could lead to the
Regulatory Law for the Application of Herbal Products most effective use and reap the greatest benefits. They may also
• A new European directive The Traditional Herbal Medicinal help to revolutionize Thai herbal products, raise the value of Thai
Products Directive (THMPD) was implemented by the European Union herbs, and improve the country's traditional herbal medicine industry
(EU) in April 2011. It aims to protect public health and ensure the safety in the long run.
of herbal products being sold within the EU.
According to the directive, herbal medicines intended to treat minor
health conditions are required to be registered as traditional-use products
with the regulatory authority in every EU member state in which the product More Information Service Info C009
is to be sold (despite the fact that each country's regulatory body is
supposed to accept licenses approved by other EU members). This system
is intended to reduce the possibility of a product being sold as a traditional เอกสารอ้างอิง / References
herbal medicine in one country and something else in another. Prior to the สารพฤกษเคมีี และฤทธิ์์�ทางเภสัชวิ์ทยาของสมีุนไพร ที�เป็็นส่วินป็ระกอบในพ์กัดยาตรี
THMPD, Europe had a diverse range of herbal medicine regulations, with กฏุุก กมีลลักษณ์์ ลือเรื�อง , มีีนา โรจนโพธิ์์� , สุภัทรา กลางป็ระพันธิ์์
some countries even refusing to regulate traditional herbs. Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region
www.medlineplus.gov/herbalmedicine.html#:~:text=An%20herb%20is%20
The THMPD ensures that criteria for determining whether a product a%20plant,maintain%20or%20improve%20their%20health.
is a medicine or a food supplement are consistent throughout all European www.hopkinsmedicine.org/health/wellness-and-prevention/herbal-medicine
member countries. These rules are applicable to all manufactured herbal www.medicalnewstoday.com/articles/gotu-kola-benefits#side-effects
products, regardless of whether they are sold in health food stores, drug www.singleingredientgroceries.com/black-ginger-extract-amazing-health-ben
stores, or prescribed by doctors (as it occurs in Germany). The THMPD, efits/
www.healthline.com/nutrition/pumpkin#TOC_TITLE_HDR_9
on the other hand, does not apply to herbal medicine practitioners, who www.medicalnewstoday.com/articles/help-or-hindrance-new-calorie-labeling-
can continue to mix traditional herbal remedies for individual use. rules-in-the-uk
In Europe, only products that have been used to treat a health-related www.ncbi.nlm.nih.gov/pmc/articles/PMC3887317/
complaint for at least 30 years, as well as at least 15 years are qualified www.nature.com/articles/480S98a#:~:text=US%20herbal%20products%20
are%20generally,and%20Drug%20Administration%20(FDA).
for credentialing as traditional herbal medicines. Besides, herbal products www.medicalnewstoday.com/articles/gotu-kola-benefits#side-effects
are bound by the same rules of safety and quality as pharmaceutical drugs. www.medicalnewstoday.com/articles/319463#Further-research-is-necessary
What differs is how manufacturers must prove the efficacy of their products. www.medicalnewstoday.com/articles/healthy-herbs-and-spices#summary
www.nature.com/articles/480S98a
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