WASHINGTON (AP) - 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.
The preliminary guidance issued Friday by the Food and Drug
Administration marks the first time tobacco makers will be required
to report quantities of 20 chemicals associated with cancer, lung
disease and other health problems. The FDA will require companies
to display the information in a consumer-friendly format by next
April.
Constituents or byproducts of tobacco products that are subject
to the new rule include ammonia, carbon monoxide and formaldehyde.
Regulators 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, before finalizing them.
A 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. The same law lets the agency
approve ones that could be marketed as safer than what's currently
for sale.
In 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, user behavior 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," Dr.
Lawrence Deyton, director of FDA's tobacco center, told reporters
on a conference call.
The 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 stigma.
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 cigarettes.
Industry experts expect it will take the FDA a year or more to
review applications for modified risk products.