Tobacco companies will have to begin reporting the amount of unsafe chemicals in their products and prove their so-called lower-risk alternatives to smoking such as snuff are actually safer, U.S. regulators said.
The Food and Drug Administration moved today to implement pieces of a 2009 law giving the agency the authority to regulate tobacco products. The FDA released preliminary guidelines for the industry that it says can educate consumers on exactly what is in cigarettes, such as ammonia and formaldehyde, and police claims that certain tobacco products may be safer than others.
The agency will share information on chemical amounts with the public within a year, Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a telephone call with reporters. On the issue of less-risky tobacco items, the draft guidelines set up two categories: one with a higher evidence standard that lets companies claim less harm than cigarettes; and another with a lower standard that permits companies to market products as reducing exposure to unsafe ingredients.
“We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” FDA Commissioner Margaret Hamburg said in a statement. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.”
The FDA released a list of 93 chemicals that tobacco makers would have to report the quantity of in their products. The FDA is studying how best to disseminate the information publicly.
“Most people do understand tobacco use is harmful,” Deyton said. “There are also studies that people don’t really understand why to the extent the various chemicals in tobacco are harmful.”
The agency said in the draft on reduced-risk products -- which include electronic cigarettes, tobacco lozenges, snuff and snus -- that it’s asking for scientific information, including research findings related to a manufacturer’s claim, and may request data comparing the product with cigarettes.
Products in the two categories will be asked to show reduced risk and a benefit to the health of tobacco and non-tobacco users before companies can market them as safer, according to the draft guidelines. The companies also could advertise the products as offering less exposure to harmful ingredients if they prove that future studies may reveal a reduction in disease and death when compared with cigarettes.
Reynolds American Inc. (RAI) and its American Snuff unit asked the FDA in July to change labels on smokeless products to: “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” Current labels say the product isn’t a safe alternative to cigarettes.
Altria Group Inc. (MO), which owns Philip Morris USA and brands including Copenhagen and Skoal, wrote the agency “there is overwhelming scientific, medical and public health consensus that moist smokeless tobacco products” such as snuff or snus, “are substantially less hazardous than cigarettes.”
Snuff and snus are moist powder tobacco that goes under the lip either loose or in a packet.
Shares of Richmond, Virginia-based Altria gained less than 1 percent to $30.87 at the close in New York, while Winston-Salem, North Carolina-based Reynolds increased 1.2 percent to $41.46. Star Scientific Inc. (STSI) fell 2.4 percent to $3.28.
Star Scientific filed an application with FDA in February 2011 to market its snuff product Stonewall Moist-BDL. Star, based in Glenn Allen, Virginia, said in a statement then that it was the first FDA application for approval of a tobacco product.
Smokeless tobacco can cause mouth cancer, oral health diseases and nicotine addiction, according to the Atlanta-based Centers for Disease Control and Prevention. About 3.5 percent of U.S. adults used smokeless tobacco in 2009. Skoal held 25 percent of the market share the same year, followed by Copenhagen with 24 percent, according to the CDC.
Independent third parties should be required to assess the health effects of modified-risk tobacco products before companies submit applications for review to the FDA, the Institute of Medicine in Washington, which advises the nation on health matters, recommended in a December report.
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