Agency Also Instructs Industry to Report on Deadly Product Ingredients

(March 30, 2012) —

The American Lung Association welcomes the Food and Drug Administration’s (FDA) announcement and draft guidance released today which will protect consumers from future false and misleading health claims by the tobacco industry about its deadly tobacco products. 
The guidance proposes a rigorous compliance process for the tobacco industry to claim that its products are not as harmful as products currently being sold. This guidance is based on a report requested by FDA and released in December by the prestigious Institute of Medicine (IOM). The IOM r recommended that the agency set rigorous and high research standards for any product the tobacco industry claims poses a modified, or less harmful risk, to consumers. The 2009 Tobacco Control Act, which gives FDA its authority over tobacco products, instructed the agency to work with the IOM on establishing the scientific standards that apply when FDA receives applications for a modified risk tobacco product.
The American Lung Association has been adamant that FDA be careful and deliberate in its approach to modified risk tobacco products. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) makes clear that FDA must set high and rigorous standards in order to have any modified risk product authorized.  FDA must also take into account how a so-called modified risk product is marketed by the industry and ultimately used by consumers before such a claim is authorized. In September, the American Lung Association and its health partners submitted comments to FDA urging the agency to take into consideration the industry’s decades-long history of fraud and deception when establishing this process.
“The tobacco industry has a long and terrible history of misleading the American public on the health risks associated with its products – including “light,” “low-tar” and “mild” cigarettes. Today, FDA has rightly proposed a high standard of scrutiny for any modified risk tobacco product,” said Charles D. Connor, President and CEO of the American Lung Association. “The tobacco industry’s ongoing fraud and deception on the health risks associated with smoking was front and center in the racketeering trial where a federal judge found Big Tobacco guilty on charges of civil racketeering.” Under the Tobacco Control Act it is required that before allowing any modified harm claims be made, scientific research must be conducted to evaluate the validity that these products are truly less harmful, modified risk tobacco products. The Lung Association strongly supports independent third-party testing conducted by researchers pre-approved by FDA to ensure the tobacco industry’s research submissions are valid.
FDA also released draft guidance that moves the industry ahead on testing of 20 of the most potentially harmful tobacco product constituents, including arsenic, ammonia, formaldehyde and benzene. The Lung Association welcomes this initial step but urges FDA to require testing of all 93 harmful and potentially harmful constituents the agency has identified as necessary to move forward with its product regulation.
Earlier this year, the American Lung Association and its health partners filed comments on the importance of FDA moving forward with requiring all tobacco product manufacturers to provide full disclosure of its product’s harmful or potentially harmful constituents. These comments address that such disclosure must be made available to the public, but it cannot lead to misperceptions about the relative risk of different brands or products, or create misperceptions about the health impact of products based on the presence or absence of specific ingredients or constituents. The American Lung Association has called for FDA to conduct follow-up surveys that determine how consumers perceive and digest information about modified tobacco products to ensure consumers do not find the information misleading.
“It is very important how the FDA makes this information available,” said Connor. “But it can’t be done in a way that allows the industry to thwart other parts of the law and continue its deception of consumers.&rdquo

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