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FDA’s logjam of new tobacco product authorizations substantially broken

| June 26, 2013

Lorillard has become the first company in the US to receive authorization from the Food and Drug Administration for marketing products ‘substantially equivalent’ to products already on the market.

Under the Tobacco Control Act of 2009, new cigarettes cannot be introduced on the US market without an order from the FDA, and there are two routes to obtaining such an order. One route, for completely new tobacco products, requires a highly detailed review, while a second route provides for products that are ‘substantially equivalent’ to those already on the market.

In March, a story by Jacob Grier for the Atlantic Monthly quoting a report by Michael Felberbaum for Associated Press said the FDA had till then issued no rulings on the approximately 3,500 tobacco-product substantial equivalence reports it had received, despite having 115 employees reviewing them.

Lorillard said yesterday that it had received notification from the FDA that its Newport Non-Menthol Gold Box and Box 100 products had been found to be substantially equivalent to tobacco products previously commercially marketed in interstate commerce in the US.

The FDA’s finding permits Lorillard to begin marketing the new products, consistent with all existing requirements of regulated tobacco products.

“We are very pleased that the FDA has found that Lorillard’s Newport Non-Menthol Gold products are substantially equivalent to existing tobacco products currently marketed,” said chairman, president and CEO, Murray Kessler.

“As such, we are proud to be the first company in the industry to receive authorization to begin marketing these new products in the US through the FDA’s substantial equivalence pathway.

“We are encouraged by the Agency’s fulfillment of its obligation prescribed in the Family Smoking Prevention and Tobacco Control Act of 2009 and believe that the FDA has carried out is evaluation process in a deliberate manner reflecting sound science. We look forward to continuing productive engagement with the Agency moving forward.”

Meanwhile, Bonnie Herzog, managing director, Beverage, Tobacco and Consumer Research at Wells Fargo Securities described the FDA authorizations as a very positive development for Lorillard and the tobacco sector as a whole.

She said that the director of the FDA’s Center for Tobacco Products, Mitch Zeller, had indicated that the first decisions, which included four rejections, were just the first of many product review decisions to be issued.

Category: Breaking News

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