Lorillard Wins FDA Approval of Tobacco Products

FDA is clearing the way for Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box under a “substantially equivalent determination.”

June 27, 2013

NEW YORK – The Food and Drug Administration (FDA) approved two new tobacco products for Lorillard Inc. under a “substantially equivalent determination,” Bloomberg reports.

The clearance applies to two of Lorillard’s Gold Box cigarettes for sale in the U.S. — Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box — and are the first rulings handed down by the FDA since it was given authority in 2009 to regulate tobacco products.

The FDA cleared the two cigarettes, saying they had the same characteristics as existing ones.

“We are proud to be the first company in the industry to receive authorization to begin marketing these new products in the U.S. through the FDA’s substantial equivalence pathway,” said Murray Kessler, Lorillard’s chairman and CEO. The agency “carried out its evaluation process in a deliberate manner reflecting sound science,” he said.

The FDA said for legal reasons, it couldn’t reveal which substantially equivalent requests they denied.

“While today’s development is a positive step, there is still work to be done,” said Bonnie Herzog, an analyst at Wells Fargo & Co. in New York, said today in a note to clients. The lack of FDA substantial equivalence rulings “has been an overhang,” she said.

There is a backlog of requests at the FDA. As of earlier this month, there were 500 requests to approve new products and 3,500 for products already in stores.

“Today’s decisions are just the first of many forthcoming product review actions to be issued,” said Mitch Zeller, head of the FDA’s Center for Tobacco Products.

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