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Regulatory science for public health: From functional food to modified-risk tobacco products
Date:8/19/2012

tobacco products on the US market.

Richardson, a food scientist, at Reading University in the UK says that the use of claims in the food and dietary supplement market is widespread. But supermarket shelves may look very different as regulators crack down on false and misleading claims.

In the EU for example, regulation published in May this year (Regulation EC No 432/2012) concerning the well-established nutrient functions of vitamins and minerals could see hundreds of nutritional and health claims become illegal. The European Commission has published a list of more than 1600 unauthorised claims on the EU Register. All labels and commercial communications must comply with the regulation by 14th December 2012 following a six-month transitional period.

The result he says is that we must achieve an important balancing act between overcoming challenges in generating and presenting scientific data to justify a claim and achieve conclusive evidence of cause and effect, while not reducing a company's willingness to invest in new research and innovation or impacting international trade.

But whereas health claims on food and nutritional supplements are commonplace,the possibility of making reduced-risk claims is a new prospect for modified risk tobacco products which manufacturers might seek to place on the US market. Under the FSPTCA, companies can apply to the FDA to market lower-risk tobacco products in the US providing they provide scientific proof that marketing of the product will not only reduce harm to individual users but also benefit the population as a whole.

The FDA has started to draft guidance on the kind of scientific and other data needed to forecast and monitor a proposed modified risk tobacco product's potential impact on public health, including: product characterization; the amount of human exposure to harmful constituents; perceptions about the product and effects on human health.

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Contact: Dr. William Town
bill_town@mac.com
44-772-030-7693
Kilmorie Clarke Ltd
Source:Eurekalert

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