After 2 and a half years of fumbling the Swedish Match application for Modified Risk Tobacco Product (MRTP) status on their General Snus products sold in US convenience stores, the FDA announced on Dec 14th they had taken "action".
After a careful review of the entire MRTPA process concerning General Snus and FDA's eventual ruling, a fair-minded person can only conclude that NO tobacco product will ever win MRTP status, regardless of the merits, from this FDA Center for Tobacco Products.
This begs the question, Congressional mandate notwithstanding, why does FDA perpetuate this cruel, expensive, and time consuming farce? Simply make the MRTPA process a one page form, hold the required public comment period, and then deny the application. That would save both the government and the manufacturer huge amounts of money while delivering the same outcome as the current process...minus the hypocrisy.
Today, FDA announced it was authorizing the sale and marketing of eight Swedish Match smokeless tobacco products in the US.
These first eight are not in the snus category but their approval would seem to indicate that all Swedish Match snus falling within the qualifying date range should easily win approval.
Swedish Match as of last month had 195 product applications on file with FDA.
FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco. Instead, FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco use causes.
To legally market a new tobacco product in the United States, a manufacturer must receive a written order from FDA permitting the marketing of the new tobacco product under one of three pathways. These three pathways are:
There have been many questions and much confusion concerning the Kennedy/Waxman legislation since it became law on June 22, 2009. What does FDA regulation of tobacco really mean? Why aren't cigars or pipe tobacco treated the same way under the law as Cigarettes, RYO (roll your own), and Smokeless Tobacco or all kinds? When does all this go into effect? How does it affect me as a tobacco manufacturer, distributor, retailer, or consumer?
"This is a wake-up call for the public health community," says Gregory Connolly of Harvard School of Public Health. "It's a total sea change."
For smokers who can't light up in the office or at a restaurant, a new aspirin-sized tablet, called "Camel Orb," will let tobacco melt in their mouth. The dissolvable product — arriving January in stores in Portland, Ore., Columbus, Ohio, and Indianapolis — is the first such product by a major tobacco company and is part of a booming market in smokeless alternatives to cigarettes as smoke-free laws sweep the nation.
"It's meeting the needs of smokers," says Rob Dunham, of R.J. Reynolds, maker of Orb and Camel cigarettes. With lozenge-like Orb, he says there's no smoke, no spit, no litter.
In the past two years, the nation's two largest cigarette companies, R.J. Reynolds and Philip Morris USA, have moved into the smokeless tobacco market as cigarette sales continue to fall. Each introduced smokeless pouches or "snus, " touted as spit-free products that sit inside the mouth. They also bought smokeless tobacco companies.
"We've been very pleased with the consumer response" to Marlboro Snus, says David Sutton, spokesman of Altria Group, which owns Philip Morris USA. He says smokeless is a "growing category" with sales rising 6%-8% annually. He says cigarette sales are falling 2%-3% each year.
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