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Tobacco companies will be required to report the levels of dangerous
chemicals found in cigarettes, chew and other products under the latest
rules designed to tighten regulation of the tobacco industry.
preliminary guidance issued Friday by the Food and Drug Administration
marks the first time tobacco makers would be required to report
quantities of 20 chemicals associated with cancer, lung disease and
other health problems. The FDA will release the information in a
consumer-friendly format by next April.
"Cigarettes are the
only mass-consumed product in this country for which consumers don't
know what's in them, until now," said Dr. Lawrence Deyton, director of
FDA's tobacco center, in an interview with the Associated Press.
Ammonia, carbon monoxide and formaldehyde are among the ingredients or byproducts of tobacco that are subject to the new rule.
have identified more than 93 harmful or potentially harmful chemicals
in tobacco products, though the agency is only focusing on 20 for the
coming year. The agency will take comments on the guidance until June 4.
There is no deadline for when the documents will become final.
law enacted in 2009 gave the FDA authority to regulate a number of
aspects of tobacco marketing and manufacturing, though the agency cannot
ban nicotine. FDA also gained authority to set standards on levels of
harmful ingredients in tobacco products, though the agency is not yet
using that power.
The same law lets the agency approve new tobacco products that could be marketed as safer than what's currently for sale.
separate guidance issued Friday, the FDA laid out the scientific
studies it will require before any company can market a so-called
modified-risk tobacco product. Companies must submit extensive testing
data on health risks for users and non-users, behavior changes and
consumer understanding of marketing materials for new products.
"The law sets a high standard to make sure that tobacco products marketed to reduce risk actually reduce risk," Deyton said.
FDA's handling of modified-risk products has been highly anticipated by
both the public health community and bigger tobacco companies, which
are looking for new products to sell as they face declining cigarette
demand due to tax increases, health concerns, smoking bans and social
Some tobacco companies have alternatives like snus
small pouches like tea bags that users stick between the cheek and gum
and dissolving tobacco finely milled tobacco shaped into orbs, sticks
and strips. But they are not explicitly marketed as less risky than
The FDA is required to respond to a company's
application within a year of its submission and acceptance. FDA
officials would not comment on how many applications have been submitted