Good letter by Doug. Cross to DoH in answer to the DoH's bland 'reassurance'
Good letter by Doug. Cross to DoH in answer to the DoH's bland 'reassurance' letter. Ann.
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Dear All,
Can the DoH please clarify which legislation it wishes to employ when justifying the use of this chemica as a prophyllactic treatment for dental caries?
If, as it appears to be claiming, it is used as a source for supplementing so-called 'sub-optimally fluoridated drinking water' supplies with the 'mineral' fluoride, under the provisions of the Food Supplements Directive, then the following comment is relevant. The fact that fluorosilicic acid may conform in its manufacture with a British Standard does NOT constitute its qualification as a supplementary mineral. Since it is NOT an authorized source of the mineral 'floride' as specified in Annex 2 of the Food Supplements Directive, the fact that it complies with a BS quality standard for an industrial chemical is irrelevant. Its absence from Article 2 means that it is prohibited from use as a food additive. Nominating its use for this purpose under the Water Act 2003 is in violation of the European Food Supplements Directive, and for this reason the Act is open to challenge, including Judicial Review in the UK and review by the EC .
However, if fluorosilicic acid is not a food supplement as described by the term 'mineral' under the Food Directive and Act, it can only instead be a substance that is used in the prophylactic treatment of dental caries - in other words, a medicinal product as clearly specified in Article 1 of the Medicines Directive. If the authorities wish to hold that this is indeed its purpose , then the fact that fluorosilicic acid may conform in its manufacture with a British Standard does NOT constitute its authorisation for use as a pharmaceutical product. The DoH is fully aware that ALL medicinal products must be produced under pharmaceutical manufacturing conditions (this is not the same as is required for industrial chemicals), and under the supervision of 'Qualified Persons' within the pharmaceutical industry.It is also fully aware that all such products may only be used when they have the relevant marketing authorization. Since no such authorization exists for either fluorosilisic acid or any diluted solutions of it, then its use as a pharmaceutical product is illegal, and even its promotion and advertising is a criminal offence under the provisions of the Medicines Act.
Doug Cross
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Dear All,
Can the DoH please clarify which legislation it wishes to employ when justifying the use of this chemica as a prophyllactic treatment for dental caries?
If, as it appears to be claiming, it is used as a source for supplementing so-called 'sub-optimally fluoridated drinking water' supplies with the 'mineral' fluoride, under the provisions of the Food Supplements Directive, then the following comment is relevant. The fact that fluorosilicic acid may conform in its manufacture with a British Standard does NOT constitute its qualification as a supplementary mineral. Since it is NOT an authorized source of the mineral 'floride' as specified in Annex 2 of the Food Supplements Directive, the fact that it complies with a BS quality standard for an industrial chemical is irrelevant. Its absence from Article 2 means that it is prohibited from use as a food additive. Nominating its use for this purpose under the Water Act 2003 is in violation of the European Food Supplements Directive, and for this reason the Act is open to challenge, including Judicial Review in the UK and review by the EC .
However, if fluorosilicic acid is not a food supplement as described by the term 'mineral' under the Food Directive and Act, it can only instead be a substance that is used in the prophylactic treatment of dental caries - in other words, a medicinal product as clearly specified in Article 1 of the Medicines Directive. If the authorities wish to hold that this is indeed its purpose , then the fact that fluorosilicic acid may conform in its manufacture with a British Standard does NOT constitute its authorisation for use as a pharmaceutical product. The DoH is fully aware that ALL medicinal products must be produced under pharmaceutical manufacturing conditions (this is not the same as is required for industrial chemicals), and under the supervision of 'Qualified Persons' within the pharmaceutical industry.It is also fully aware that all such products may only be used when they have the relevant marketing authorization. Since no such authorization exists for either fluorosilisic acid or any diluted solutions of it, then its use as a pharmaceutical product is illegal, and even its promotion and advertising is a criminal offence under the provisions of the Medicines Act.
Doug Cross
posted by Bill at
10:08 AM
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