Tobacco giant Altria wants to tell the world that its Copenhagen snuff is a safer alternative to smoking cigarettes, and on Thursday an FDA advisory panel agreed that the science appears to support the claim.
Following a Feb. 6-7 hearing, the Tobacco Products Scientific Advisory Committee (TPSAC) voted 8-0, with 1 abstention, that the manufacturer’s proposed “modified risk” claim for Copenhagen Snuff Fine Cut is scientifically accurate.
Altria has petitioned to include the following on the product’s label: “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”
“This is an important step for tobacco harm reduction,” said Joe Murillo, vice president of regulatory affairs for Altria Group. “It is critical that adult smokers have accurate information that will help them switch to non-combustible tobacco products.”
The FDA, since 2009, has had the regulatory authority to grant modified risk tobacco product (MRTP) status to those proven to pose lower health risk than traditional combustible cigarettes, but it has never done so.
As of late last year, federal health officials had denied or delayed close to 20 MRTP applications from mostly smokeless tobacco products.
At the two-day public hearing, the advisory panel heard testimony on two pending MRTP applications – Altria’s labeling application for Copenhagen Snuff Fine Cut and a request by “snus” smokeless tobacco manufacturer Swedish Match. TPSAC members reached no consensus on whether the latter’s proposed reduced-risk claims were justified.
In his TPSAC presentation to the committee, Murillo noted that snuff similar to the Copenhagen product has been marketed for almost 200 years.
“Products like Copenhagen snuff are not risk free. But they are substantially less hazardous than cigarettes — specifically, as it relates to lung cancer,” he said. “This is the overwhelming consensus of the scientific, medical and public health communities. It is a scientific fact, but adult smokers don’t understand this fact.”
He said that in survey after survey, most adult smokers erroneously reported that smokeless tobacco products were as harmful or more harmful than cigarettes.
According to the CDC, about 128,000 smokers die of lung cancer every year. Murillo noted that the 23 million adult smokers in the U.S. would be likely to use a reduced harm tobacco product if they actually believed it was safer than combustible cigarettes.
But he said more than half of these smokers don’t know that snuff and other smokeless tobacco products represent reduced harm alternatives to cigarettes.
Murillo conceded that the appeal of Copenhagen snuff and other snuff products is limited.
“Consumers of Copenhagen snuff are by and large adult white males who are 35 years of age and older. We recognize that no single product or category of products will appeal to all adult smokers who are looking for reduced risk alternatives. That is why we believe there must be a portfolio of products with FDA-authorized modified risk claims. We are starting with Copenhagen snuff,” he said. “Authorizing this claim would be an important first step toward solving the dilemma faced by adult smokers. We can give them a reason to switch.”
By emphasizing the older age group, Murillo may have been seeking to distance Altria’s product from Swedish Match’s snus. When the TPSAC discussed the latter product on Wednesday, several panel members hesitated to support the MRTP designation because they feared it could make snus more attractive to young people.
At the close of the Thursday meeting, TPSAC chair Robin Mermelstein, PhD, said the consensus among committee members was the reduced harm claim for Copenhagen snuff was reasonably interpreted by the public, and not misinterpreted to mean that the product was risk free.
“I am hearing a consensus that this was an understandable statement. It was clear. There may be things that need to be tweaked, but there is no great concern that it is a harmful message. I think it is a reasonable place to start in messaging,” she said.
The FDA is not obliged to follow recommendations by its advisory committees, but it usually does.
Source: MedicalNewsToday.com
