Herbal medicinal ingredients have been used for centuries in traditional remedies and natural health products. However, their classification and use in food supplements can often be confusing. In this article, we’ll explore what herbal medicinal ingredients are, and why they cannot be used in food supplements in the UK without a license.
What Are Herbal Medicinal Ingredients?
Herbal medicinal ingredients are substances derived from plants that have traditionally been used to prevent, treat, or alleviate health conditions. These can come from various parts of plants, including the leaves, roots, flowers, seeds, or bark. Some well-known herbal medicinal ingredients include:
- Echinacea – used to boost the immune system
- Ginseng – often taken to enhance energy and vitality
- St. John’s Wort – commonly used for mental well-being
- Valerian Root – taken for sleep and relaxation
These plant-derived substances can be potent, often acting similarly to pharmaceutical drugs. This is why, despite their natural origins, they are tightly regulated when intended for use in therapeutic or medicinal contexts.
Herbal Medicinal Ingredients vs. Herbal Supplements
It’s important to distinguish between herbal medicinal ingredients and herbal supplements. While both come from plants, their regulatory treatment differs significantly. Herbal supplements may contain botanical ingredients that provide general nutritional support (e.g., vitamins, minerals, or antioxidants), while herbal medicinal ingredients are specifically used to treat or manage health conditions.
For example, turmeric may be used in supplements for general wellness and anti-inflammatory benefits. However, when its concentration is increased for medicinal purposes, it would be classified differently and subjected to more stringent regulations.
Why Herbal Medicinal Ingredients Can’t Be Used in UK Food Supplements
In the UK, food supplements are regulated under the Food Supplements (England) Regulations 2003, which allows for the inclusion of vitamins, minerals, and certain nutrients that have physiological effects. However, herbal medicinal ingredients fall under a different regulatory category. These ingredients are classified as medicinal based on their traditional use and effects, not just on the claims made about them.
This means that even if no health claims are made, herbal medicinal ingredients such as echinacea, St. John’s Wort, or valerian root cannot be used in food supplements. These herbs are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) as medicinal products, and any product containing them must be licensed as a Traditional Herbal Medicinal Product (THMP). This ensures that such products meet strict standards for safety, efficacy, and quality.
Simply avoiding health claims does not allow the use of these ingredients in food supplements. If an ingredient is classified as medicinal due to its traditional use or pharmacological properties, it can only be included in licensed medicinal products.
The Role of the MHRA and THMP Registration
The MHRA ensures that all medicinal products, including herbal medicinal products, meet strict standards before they are made available to consumers. This includes testing for the correct dosage, ensuring the product does what it claims, and verifying that the benefits outweigh any potential risks.
If a manufacturer wants to sell a product containing herbal medicinal ingredients in the UK, they must apply for a THMP license. To obtain this license, the product must show evidence of traditional use over a period of at least 30 years, including 15 years within the European Union. Additionally, the manufacturer must demonstrate that the product is safe to use and provide clear, consistent information on the label.
This licensing process is extensive and ensures that only products with proven safety and efficacy can be sold as herbal medicines. Products without this licensing cannot be marketed with any medicinal claims and, as such, cannot be used in food supplements.
Conclusion
Herbal medicinal ingredients offer powerful benefits, but in the UK, they cannot be used in food supplements due to strict regulations governing their medicinal properties. The distinction between food supplements and medicines is crucial, as food supplements are intended to support general health and wellness, while herbal medicinal ingredients are subject to the rigorous standards of the MHRA and must be licensed as Traditional Herbal Medicinal Products. For manufacturers and brands operating in the UK, understanding these regulations is key to ensuring compliance and the safety of their customers.
At Nutribl, we specialise in offering private-label supplements that meet all UK and EU regulatory standards, ensuring your products are safe, effective, and compliant with the law. By working with us, you can confidently deliver high-quality food supplements while navigating the complexities of herbal medicinal ingredient restrictions.