Globally many consider herbs and botanicals to be natural and therefore healthier and gentler than conventional drugs. Currently, 30% of prescription drugs are herbal and botanical drugs. Herbals and botanicals are used for the treatment and improvement of health and well-being. Many countries use herbal and botanical drugs traditionally for many years to generations. The regulation for botanical and herbal products varies from country to county.
Also, the use of herbal and botanical products varies from country to country. Some country’s use as a supplement, some use for general health while others permit use for medicinal purposes. Botanicals and herbals are sold in many forms such as tablets, capsules, pills, syrups, etc.
So let’s first look at what are botanicals and herbal products.
What are herbal and botanical products?
A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health are sometimes called herbal products, botanical products, or phytomedicines.
Herbal medicines are those with active ingredients made from plant parts, such as leaves, roots, or flowers. Products made from botanicals, or plants, that are used to treat diseases or to maintain health are called herbal products, botanical products, or phytomedicines. A product made from plants and used solely for internal use is called an herbal supplement.
However, there is a thin negligible layer of difference between herbals and botanicals.
World Health Organization (WHO) view on Herbal and Botanical products
The World Health Organization (WHO) has recognized the role of botanicals in traditional herbal medicines and published a series of monographs on selected medicinal plants. These monographs present technical reviews of the quality, safety, and efficacy of commonly used herbal medicines, with the intention to harmonize the use of herbal medicines internationally.
Herbal and Botanical products market
As per a report, the global botanical ingredients market size was estimated at USD 131.5 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 7.0% from 2020 to 2027. This growth is thought to be due to growing consumer awareness towards health and safety and this would have a positive impact on the market for botanical ingredients.
Products like Ginkgo Biloba, ginseng, echinacea, and garlic are the major selling botanical products in the U.S. Ginkgo biloba became popular for its anti-inflammatory and anti-infective properties in the U.S. Ginseng is known for its high content of phenolic compounds, ginsenosides, and saponins, such as carotenoids and carbohydrates and is used for various uses such as Anti-oxidant, control blood sugar, etc.
Regulation of Herbal and Botanical products in various countries
In the USA, dietary supplements include botanical food supplements and are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994. Approval from the FDA is not required before marketing dietary supplements in the United States.
However, DSHEA prohibits the marketing of dietary supplements that are adulterated or misbranded and places the responsibility and discretion of ensuring the safety of products and compliance to labeling requirements on the manufacturers and distributors of the products.
The “New dietary ingredients (NDIs)” or ingredients used in dietary supplements that have not been marketed in the USA before 1994 are required to be notified to the FDA with information on the identity and safety of the ingredient before being marketed.
Companies seeking to bring herbal medicinal products to the market in the EU Member States should follow the national procedures overseen by national competent authorities.
There are three main regulatory pathways to market a herbal medicinal product in the EU Member States:
- Traditional use registration
- No clinical tests and trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are demonstrated
- Involves assessment of mostly bibliographic safety and efficacy data.
- Must have been used for at least 30 years, including at least 15 years within the EU.
- Are intended to be used without the supervision of a medical practitioner and are not administered by injection.
- Well-established use marketing authorisation
- Scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety.
- Involves assessment of mostly bibliographic safety and efficacy data.
- Stand-alone or mixed application
- This requires Safety and efficacy data from the company’s own development or a combination of own studies and bibliographic data.
Most dietary supplements, including botanical food supplements, fall within the areas of either “Foods in General” or “Foods with Health Claims” with the difference being the presence of health claims on products.
Products classified as “Foods in general” are not subject to pre-market authorizations or notifications. However, Foods with Health Claims, which are further defined as either “Foods for Specified Health Uses” (FOSHU), “Foods with Nutrient Function Claims” (FNFC), or “Foods with Function Claims” (FFC), are regulated with different pathways ranging from a rigorous and lengthy approval process for FOSHU to shorter pre-market notifications for FFC.
In Australia, the TGA considers the botanical food supplements as “Complementary medicines,” and a risk-based tiered approach is taken with regard to the regulation of complementary medicines. The lower-risk medicines are merely listed on the Australian Register of Therapeutic Goods (ARTG). The regulators do not evaluate the therapeutic indications on listed medicines, whereas registered medicines are evaluated for quality, safety, and efficacy before they are accepted.
Dietary supplements such as botanical food supplements, are regulated as “health foods”. Chinese market entry regulations have been recently revised, replacing a lengthy registration procedure with a notification-based approach for basic vitamin and mineral-containing products.
However, other health food products are still required to undergo extensive testing and premarket approval. In detailed rules published by the CFDA, new ingredients used in health food are required to be supported by a package of toxicological data, including an acute oral toxicity study, 3 genotoxicity assays, and a 28-d oral toxicity study. Based on the outcome of these studies, additional studies such as 90-d oral toxicity studies, teratogenic, and reproductive toxicity studies may also be required.
Canada regulates botanical food supplements as “Natural health products (NHPs)“. Premarket authorization of NHPs is required, for which detailed information on the product’s medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended dose/use is required. Labels are an important tool to assist Canadians in making informed health choices when selecting and using NHPs.
Pre-market authorizations requirements in the above countries
Let’s briefly look at the pre-market authorizations requirements in the above-discussed countries.
|Country||Legislation instrument||Pre-marketing authorization requirement|
|USA||Dietary Supplement Health Education Act (DSHEA) 1994||No|
|European Union||Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements||No Botanical ingredients meeting the definition of “novel food” must be first authorized|
|Australia||Therapeutic Goods Act||Yes|
|Japan||Food Sanitation Act (Act No. 233, 1947)||No (for ‘Foods in general’ category)|
|Yes (for ‘Foods with health claims’ category)|
|China||Food Safety Law of the People’s Republic of China and||Yes|
|Measures for the Administration of Registration and Recording of Health Food|
Need support for your herbal & botanicals registration globally?
Credevo offers expertise in drug product registration, clinical trial regulations, and many more services globally. Provide the details to connect with us and explore our services.