UNITED STATES
FDA issues guidance on harmful constituents

The U.S. Food and Drug Administration (FDA) released new preliminary guidelines that require tobacco companies to specify the quantities of dangerous chemicals found in tobacco products.

Beginning 22 June 2012, manufacturers of tobacco products and importers of such products or their agents must submit a list of the potentially harmful constituents in those products and in the smoke they produce – and report it by the quantity found in each brand.
The requirements are specified in the FDA's "Draft Guidance on Harmful and Potentially Harmful Constituents in Tobacco Products" issued on 30 March.
While there are more than 7,000 chemicals in tobacco and its smoke, the FDA has established a list of 93 harmful and potentially harmful constituents (HPHCs) including ammonia, formaldehyde and carbon monoxide.
The draft guidance identifies 20 HPHCs on which the agency will focus enforcement efforts during 2012. The FDA will make information about the amounts of HPHCs in specific products available to the general public by April 2013.
The FDA said its list may not include every potentially harmful constituent, partly because it focused on only five disease outcomes: cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction. FDA will continue to review scientific information, and it may add or remove constituents in the future.
"We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers," said FDA Commissioner Margaret Hamburg in a statement. "We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death."
The FDA on 30 March released two draft guidance documents that implement provisions of the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA the power to regulate the tobacco industry. A second draft called "Draft Guidance on Modified Risk Tobacco Product Applications" provides guidance to companies that seek to market a tobacco product as one which reduces the risk of tobacco-related diseases. (pi)

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