Earl Baldwin of Bewdleyasked Her Majesty's Government:
In the light of the finding of the Opinion of Lord Jauncey of Tullichettle in the case of McColl v. Strathclyde Regional Council that fluoride falls within the definition of a "medicinal product" under Section 130 of the Medicines Act 1968, and of the European Directive 65/65, whether they will instruct the Medicines Control Agency to reassess the status of (a) fluoridated toothpaste; (b) fluorides when used for the fluoridation of water supplies; and (c) water artificially fluoridated at 1 part per million, on the grounds that these substances are medicinal by claim or function, and are administered with a view to correcting or modifying physiological function; and, if not, why not. [HL3045]
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Hayman)The Medicines Control Agency (MCA) acts on behalf of the licensing authority (Ministers specified by the Medicines Act) and has a duty under the law to determine whether a product is a medicinal product. If new evidence were produced that a product which had not been classified as a medicinal product should be so classified, the MCA would look at that product.
Lord Jauncey's judgment predates the legislative framework set out in my earlier Answer of 12 May at 40WA col. WA 147–148, and the Government are content, on the basis of the available evidence, that present arrangements provide the public with adequate protection. However, we are currently considering a review of the scientific evidence on fluoridation. Should this produce new evidence, the MCA would have a duty to look at the classification of products containing fluoride, including fluoridated toothpaste. Fluorides for the purpose of fluoridation of water supplies and the water itself are not medicinal products. Fluoride for fluoridation is a raw material, and these are usually starting materials and not medicinal products controlled under medicines legislation, and water is regulated partly under the Food Safety Act 1990 and partly under water legislation. The regulatory regimes for foods and medicines are mutually exclusive.