FDA Takes New Steps in 'Tobacco Epidemic' Fight

ROCKVILLE, Md. -- The Food and Drug Administration (FDA) issued two separate actions today in the Obama Administration's continued bid "to help fight the tobacco epidemic and stop children from using tobacco."

The first draft guidance directs tobacco companies to submit the harmful and potentially harmful chemicals -- and the amount of each one -- contained in any tobacco product, as required by the Family Smoking Prevention and Tobacco Control Act. The second draft guidance gives companies the information needed to submit applications to market or advertise modified risk tobacco products.

"These are critical steps in achieving the FDA's mission to protect the public's health," Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products (CTP), explained in a conference call this afternoon.

In line with the requirement to account for the ingredients in tobacco products, the FDA also established a list of 93 harmful and potential harmful constituents (HPHCs) that tobacco companies will be required to report for every regulated tobacco product sold in the United States. The agency's goal is to make the information on the amount of HPHCs in specific products available to the public in a consumer-friendly format by April 2013.

Of those 93 HPHCs, the agency has identified 20 that tobacco companies will be required to report this year. The remainder will be phased in over time, Deyton said. The first 20 include ammonia, nicotine, formaldehyde and carbon monoxide. The HPHCs include chemicals found in tobacco naturally and those generated when tobacco is smoked, said Dr. David Ashley, director of the CTP's Office of Science.

The second guidance follows the Tobacco Control Act's established scientific criteria that an applicant's tobacco product must meet before the FDA can allow the product to be sold and marketed as modified risk. It describes scientific studies and analyses an applicant must submit to demonstrate that the product will, or is expected to, significantly reduce harm or exposure to individuals, and benefit the health of the population as a whole.

"The law sets a high standard to make sure products marketed as modified risk actually are," Deyton added.