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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.
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.