Star Scientific Bid to Gain Approval for 'Modified Risk' Snuff Shows Importance of FDA Authority Over Tobacco

Company Must Meet Strict Standards of Scientific Proof and Benefit to Public Health

WASHINGTON, Jan. 4, 2011 /PRNewswire-USNewswire/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:

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Star Scientific Inc.'s plan to submit a new, moist-snuff product for evaluation by the Food and Drug Administration as a "modified risk" tobacco product shows the vital importance of the new law giving the FDA the authority to regulate tobacco products and any health claims used to market them. The Family Smoking Prevention and Tobacco Control Act requires the FDA to apply strict scientific scrutiny to the company's claims that these products have lower levels of certain carcinogens and the agency can block any claims that it determines do not benefit public health.

It is crucial that an independent public health agency now has the authority to examine Star Scientific's assertions and to evaluate the impact of permitting any reduced risk claims on public health. For decades, the tobacco industry used misleading marketing and false claims to convince smokers that some cigarettes were less harmful than others. Now the FDA can stop these deadly deceptions.

Under the law, before a manufacturer can claim that a tobacco product carries a reduced or "modified risk," the company must demonstrate to the FDA that the product "as it is actually used by consumers, will A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products."

Therefore, the FDA must ensure there is adequate scientific evidence to support any health claims and that the marketing of the product does not discourage current tobacco users from quitting or encourage new users to start.  The FDA has authority to regulate the marketing and labeling to prevent false or misleading claims, and manufacturers must conduct post-market surveillance and studies to determine the impact on consumer perception, behavior and health.

As cigarette consumption has declined and the expansion of smoke-free policies reduces the number of places where smoking is allowed, tobacco manufacturers have pushed smokeless products as an alternative, and sales of smokeless tobacco have climbed steadily.

Most troubling, the most recent data on youth tobacco use, included in the Monitoring the Future Survey released just last month, show a significant increase in smokeless tobacco use among high school students. Among 12th graders, 8.5 percent used smokeless tobacco in 2010, a 39 percent increase since 2006. Even more alarming, 15.7 percent of 12th grade boys currently use smokeless tobacco.

Rather than reducing the number of smokers, the Monitoring the Future survey indicates that the main consequence of current smokeless tobacco products and marketing is to increase the number of youth who use smokeless tobacco. That is bad news for health because smokeless tobacco is far from harmless. Smokeless tobacco use causes oral cancer, cardiovascular disease, gum disease and tooth decay. It has also been linked to cancers of the esophagus, pharynx, larynx, stomach and pancreas.

Tobacco use is the leading cause of death in the United States, killing more than 400,000 Americans each year and costing $96 billion in health expenditures.

SOURCE Campaign for Tobacco-Free Kids