Medicine, herbal medicine, homoeopathic product, medical device, cosmetic, or food supplement?

Many people fall foul of the law, sometimes through ignorance, sometimes through greed. There are also many false claims for certain products being made on internet. The Regulations that apply to a product depends on whether it is a medicine, herbal medicine, homoeopathic product, medical device, cosmetic, or food supplement.

Medicinal Products

A medicine is a substance which is either taken or placed on the body to either cure or treat a medical disease or condition. To market a medicine a Marketing Authorisation is required for each medicinal product which is granted by the medicines regulatory bodies.

Herbal Medicines

There are many herbs with known medicinal uses and at the same time can be used as either a food or cosmetic. In the UK, the Human Medicines Regulation (2012) states that a product is a herbal medicine if the active ingredients are herbs or herbal preparations. A herbal medicine can only be used for minor health conditions which do not require medical supervision, eg the relief of hay fever, rhinitis, muscular pain and stiffness, backache, etc. If the herbal medicine claims to treat major health conditions, then it becomes a medicinal product for which a Marketing Authorisation is required. A large number of herbal medicines sold in the UK are controlled under Part 7 of the Regulations which allows herbal medicinal products to receive a traditional herbal registration.

The link below gives the list of herbal medicines granted a traditional herbal registration in the UK:
https://www.gov.uk/government/publications/herbal-medicines-granted-a-traditional-herbal-registration-thr/herbal-medicines-granted-a-traditional-herbal-registration

The link below gives the list of banned or restricted herbal ingredients for medicinal use in the UK:
https://www.gov.uk/government/publications/list-of-banned-or-restricted-herbal-ingredients-for-medicinal-use/banned-and-restricted-herbal-ingredientsbanned

Homoeopathic medicinal products

A homoeopathic medicine is when the individual is treated with highly diluted substances, frequently given in tablet form, which have the aim of triggering the body’s natural healing system. There are two regulatory schemes for homoeopathic medicines in the UK, registration scheme and national rules, and depending on which one is applied will determine whether medical conditions can be used in advertising.

Medical Devices

Medical devices are products or equipment intended for a medical use. Medical devices include pre-filled syringes, skin patches used to deliver drugs, pre-filled inhalers, insulin pens. However, there are also borderline products which can fall into several categories. Toothpastes, for example, which are intended to be used to relieve the pain of sensitive teeth can be considered either a medicinal product or a medical device but toothpastes designed with no reference to sensitivity remains as a cosmetic.

Cosmetics

A “cosmetic product” is a substance or mixture which is intended to be placed on various external parts of the human body (eg skin, hair, nails, lips) or on the teeth and gums with a view cleaning them, giving them a scent, correcting body odours and/or protecting them or keeping them in good condition. For example, a product applied to a spot to conceal it, is a cosmetic, but a product applied to a spot to treat or prevent spots is considered a medicine.

Food supplements

In the UK most products described as food supplements (such as vitamins, minerals or amino acids) are regulated as foods.

Bach flower remedies are also classified as foods. However, it should be noted that some Bach flower remedies contain levels of alcohol which would stop them from bearing health claims altogether. While it may be possible for a flower remedy to carry a nutritional claim, the nutritional claims permitted for products containing alcohol are limited.

Food law does not permit any food to make any claim, or imply that it can treat, prevent or cure any disease or adverse medical condition.

However, it should be noted that an individual selling food supplements must register as a Food Business Operator (FBO) with their local authority.

For further information please refer to: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/759581/012__GN8_-_final_2018_combined_doc_Oct.pdf

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