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Philip Morris Researchers Seek Future for 'Harmful' Business Source from: Media General News Service 12/17/2008 Cigarette companies have long pursued the holy grail of the tobacco industry: a product that is less risky to health and acceptable to consumers.
Even if Altria Group Inc.'s research efforts on that front are successful, the parent company of cigarette-maker Philip Morris USA and cigar-maker John Middleton Inc. will need an independent stamp of approval to make any health claims about new products.
That is where the Food and Drug Administration could come into play.
Public-health groups believe 2009 could finally be the year when Congress grants the FDA authority to regulate the tobacco industry.
"We're optimistic that Congress will take up the FDA bill early in the next year," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. FDA legislation passed the House by a wide margin this summer, but it was held up in the Senate, where it faced more opposition.
Opponents, including big Philip Morris competitor Reynolds American Inc. of Winston-Salem, N.C., have vowed to continue fighting the legislation. Myers said the bill has broad backing, including the support of President-elect Barack Obama.
Tobacco-control advocates say the legislation would reduce tobacco's health toll by creating a division within the FDA that would have authority over an industry that historically has had little product oversight. The FDA's powers could include further restricting certain tobacco advertising and mandating reductions in nicotine yields and harmful elements in cigarette smoke.
"It would give the FDA tremendous authority over tobacco," said Jack Nelson, Altria's executive vice president and chief technology officer. "They could not ban the product and they could not eliminate nicotine, but they could do a lot of things as long as they could demonstrate that it was in the [interests of] public health."
Yet part of the reason that Philip Morris broke ranks with other major cigarette companies in 2000 and endorsed the idea of "reasonable regulation" of the industry was because the company could benefit from it. Besides introducing a new barrier to entry in the cigarette market, FDA regulation could give the company an avenue to bring new products to market as U.S. cigarette consumption declines.
Previous attempts to introduce alternative tobacco products have met with little consumer acceptance, and cigarette companies face public-health and regulatory resistance to any claims of health-risk reduction.
"Absent some authoritative entity saying, 'Yes, this is why you ought to switch to this product because it is less hazardous,' it is really a tough road to go down," Nelson said.
Even what might constitute a reduced-risk product is a matter of vigorous debate, he said. Until those issues are settled, Nelson said, the company's focus is on developing products that are commercially viable.
The FDA legislation under consideration would set up a regulatory scheme in which companies such as Altria could apply to introduce new tobacco products. To win approval, they would have to demonstrate that the products "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users." The FDA would establish a scientific advisory panel to review new products.
Major public-health groups have backed the FDA legislation despite skepticism about whether tobacco products could ever be engineered in a way to significantly reduce risks.
Myers said the legislation lets the FDA set rigorous standards, including showing that new products would not pose a public-health risk by discouraging smokers from quitting or attracting new users.
"No federal agency has ever had the authority to review new tobacco products as they were introduced or has had the technical expertise to evaluate claims made by tobacco companies," he said. Enditem
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