How is herbal medicine regulated in other countries
Herbal supplements in the United States are considered as food by the FDA, and not drugs, which means that they are not subjected to the same regulations and standards for testing, manufacturing, and labeling as drugs. This has led some people to believe that herbal medicine may not be safe to use. However, this is not entirely accurate. In fact, herbal medicine is widely used globally, with an estimated 80% (4 billion) of people using it. As such, ensuring the safety of herbs as medicine is a major concern for government, researchers, and academic institutes.
Numerous individuals work hard to conduct various research on the safety of herbs as medicine. This research involves using animal models, lab tests, adverse event reporting systems, and epidemiological research to rule out any unsafe herbs. For instance, aristolochic acids (AAs), which are toxins commonly found in the plants of genus Aristolochia and Asarum spread worldwide, have been associated with AA-induced nephropathy (AAN) and upper tract urothelial carcinoma (UTUC) since the 1990s. Consequently, it has been banned worldwide.
Although herbal medicine is not well regulated in the US, it is well regulated in other countries. Toxic herbs are either banned or well labeled in those countries to help consumers understand the safety issues associated with using such products. Below is a list of some of the countries and how they regulate herbal medicine.
Peoples of Republic of China:
In China, herbal medicines are regulated as “traditional Chinese medicines” (TCMs) under the Chinese Pharmacopoeia. The State Administration for Market Regulation (SAMR) is responsible for regulating TCMs in China. The SAMR evaluates the safety, efficacy, and quality of TCMs through a registration process. Manufacturers of TCMs must submit applications to the SAMR that include data on the safety, efficacy, and quality of the product.
The registration process includes a review of the manufacturing process, the product’s ingredients and their quality, and the product’s stability and packaging. If the SAMR determines that the product is safe and effective, it will be registered and given a Chinese Pharmacopoeia monograph. Herbal medicines that are not registered as TCMs are considered to be unapproved drugs, and their sale and distribution are prohibited.
Taiwan (Republic of China)
Herbal medicine in China and Taiwan share the same origin (in fact, Taiwan and Republic of China were one country known the Republic of China before 1949. However, following the National Party’s failure in the civil war in mainland China, they retreated to Taiwan Island while retaining the name for the country. Meanwhile, the Communist Party took over the mainland and renamed it the People’s Republic of China, although both names refer to the same geographic area and each party claims sole legal authority over China).
In Taiwan, herbal medicines are regulated as “Chinese herbal medicines” under the Pharmaceutical Affairs Act. The Act defines Chinese herbal medicines as “medicinal substances, products, and their preparations consisting mainly of plants or minerals, or animals, or parts thereof, that are used to prevent, alleviate, or cure diseases or to adjust physiological functions.” The Taiwan Food and Drug Administration (TFDA) is responsible for regulating Chinese herbal medicines in Taiwan. The TFDA evaluates the safety, efficacy, and quality of Chinese herbal medicines through a registration process. Manufacturers of Chinese herbal medicines must submit applications to the TFDA that include data on the safety, efficacy, and quality of the product.
The registration process includes a review of the manufacturing process, the product’s ingredients and their quality, and the product’s stability and packaging. If the TFDA determines that the product is safe and effective, it will be registered and given a monograph in the Taiwan Herbal Pharmacopoeia (THP). Chinese herbal medicines that are not registered are considered to be unapproved drugs, and their sale and distribution are prohibited.
Hong Kong
In Hong Kong, herbal medicines are regulated under the Chinese Medicine Ordinance (CMO). The CMO defines Chinese medicines as “substances or preparations comprising one or more Chinese herbal medicines, which are intended for use in the diagnosis, treatment, or prevention of diseases.” The Chinese Medicine Council of Hong Kong (CMCHK) is responsible for regulating herbal medicines under the CMO. The CMCHK evaluates the safety, efficacy, and quality of herbal medicines through a registration process. Manufacturers of herbal medicines must submit applications to the CMCHK that include data on the safety, efficacy, and quality of the product.
The registration process includes a review of the manufacturing process, the product’s ingredients and their quality, and the product’s stability and packaging. If the CMCHK determines that the product is safe and effective, it will be registered and given a Chinese Pharmacopoeia (CP) monograph. Herbal medicines that are not registered as Chinese medicines are considered to be unapproved drugs, and their sale and distribution are prohibited.
Japan:
In Japan, herbal medicines are regulated as “traditional medicines” under the Pharmaceutical and Medical Devices Act. The Act defines traditional medicines as “medicinal substances or products, including crude drugs, which have been used in Japan for a long time, have been confirmed to be safe based on experience of use and scientific knowledge, and are not included in the category of pharmaceuticals or medical devices.”
The Ministry of Health, Labour and Welfare (MHLW) is responsible for regulating traditional medicines in Japan. The MHLW evaluates the safety, efficacy, and quality of traditional medicines through a registration process. Manufacturers of traditional medicines must submit applications to the MHLW that include data on the safety, efficacy, and quality of the product.
The registration process includes a review of the manufacturing process, the product’s ingredients and their quality, and the product’s stability and packaging. If the MHLW determines that the product is safe and effective, it will be registered and given a Japanese Pharmacopoeia (JP) monograph. Herbal medicines that are not registered as traditional medicines are considered to be unapproved drugs, and their sale and distribution are prohibited.
South Korea:
The Korea Food and Drug Administration (KFDA) is responsible for regulating traditional herbal medicines in South Korea. The KFDA evaluates the safety, efficacy, and quality of traditional herbal medicines through a registration process. Manufacturers of traditional herbal medicines must submit applications to the KFDA that include data on the safety, efficacy, and quality of the product.
The registration process includes a review of the manufacturing process, the product’s ingredients and their quality, and the product’s stability and packaging. If the KFDA determines that the product is safe and effective, it will be registered and given a Korean Pharmacopoeia (KP) monograph. Herbal medicines that are not registered as traditional herbal medicines are considered to be unapproved drugs, and their sale and distribution are prohibited.
Challenge to estimate safety of herbal medicine.
It’s important to keep in mind that the safety of herbal medicine depends on several factors, including the nature of the herbs themselves, the purity of the herb products during manufacturing, drug interactions between herb products and other medications, individual allergies to herbal products, the dosage of herb products, and the duration of their use. Let’s discuss each of these factors.
Nature of the herbs: Some herbs contain toxic compounds that can be harmful. For instance, comfrey (Symphytum officinale) contains alkaloids that can cause liver damage, leading to liver failure and cancer. Kava (Piper methysticum), which is used to treat anxiety and insomnia, can also cause liver damage and has been linked to cases of liver failure.
Purity of the herb products: The quality of herb products varies widely. While some poor-quality products may not be effective, adulterated products can pose safety hazards.
Drug interactions: Some herbs can interact with other medications, including blood thinners like warfarin and aspirin. For example, Ginkgo biloba, which is often used to improve cognitive function and memory, can increase the risk of bleeding when taken with blood thinners. Garlic (Allium sativum), a popular herb used to reduce blood pressure and cholesterol levels, can also increase the risk of bleeding when taken with anticoagulant medications.
Individual allergies to herbal products: We all have different physical and biological makeup, which means we may have varying allergic responses to herb products. For example, some people may be allergic to certain foods. Similarly, we may not know if we are allergic to herb products until we consume them. It’s important to start with a small dose and monitor for any allergic reactions.
Dosage of the herb products: Some herbs, like foxglove (Digitalis purpurea) and lobelia (Lobelia inflata), can be toxic in large doses and even fatal. It’s crucial to follow the recommended dosage when taking these herbs.
Duration of using herb products: Herbal products are typically used for a short period to treat a particular condition. Long-term use of some herbs, such as ephedra sinica, which is used to treat respiratory conditions, can cause cardiovascular damage, including high blood pressure, heart palpitations, and heart attack. It’s important to use herbal products as directed and for the recommended duration.
