Written question asked by Earl Baldwin of Bewdley (Crossbench), in the House of Lords. It was answered by Earl Howe (Conservative) on Thursday, 24 November 2011.

Fluoridation

Question: To ask Her Majesty’s Government whether the statement by the Medicines and Healthcare Products Regulatory Agency in its lay summary for licensed product 00036/0103 that this "contains sodium fluoride, which helps prevent tooth decay" indicates that toothpastes with added fluoride require medicinal product licences.

Answer: It is the Medicines and Healthcare Products Regulatory Agency's (MHRA) view that the presence of fluoride in toothpaste does not, in itself, make the product a medicinal product. Oral hygiene products are permitted by the cosmetics directive to contain fluoride to a maximum strength of 0.15 per cent. Accordingly, the MHRA considers that a toothpaste containing more than 0.15 per cent of fluoride falls within the definition of a medicine, but those with lower concentrations do not.

Secondary information