FDA Announces Decisions On New Tobacco Products
June 26, 2013

First New Cigarettes Receive FDA Approval For Sale In The US

redOrbit Staff & Wire Reports - Your Universe Online

For the first time since being given the authority to regulate tobacco products four years ago, the US Food and Drug Administration (FDA) has authorized the marketing of two new types of cigarettes.

The new products, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, are manufactured by Greensboro, North Carolina-based Lorillard Inc., according to Bloomberg’s Anna Edney and Chris Burritt.

“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” FDA Commissioner Margaret A. Hamburg said in a statement. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”

The Newport-brand cigarettes are the first clearances to new tobacco products since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA regulatory oversight over such goods, according to a Reuters report.

“The FDA cleared the cigarettes through a ‘substantially equivalent’ determination that makes a judgment as to whether products have the same characteristics as existing ones or raise new public-health questions,” Edney and Burritt added. “The agency denied four other requests for the determination, it said today in a statement.”

“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,” Murray Kessler, Lorillard’s chairman and chief executive officer, told Bloomberg on Tuesday. He added the agency “carried out its evaluation process in a deliberate manner reflecting sound science.”

The FDA was unable to name the four products which failed to win approval for legal reasons, but revealed their applications were denied because they were found to be not substantially equivalent (NSE) to items currently being marketed.

The agency said “any product that raises different questions of public health” would be found NSE and would not be allowed to be marketed. It added “a variety of factors contributed to the four NSE decisions announced today, including a lack of evidence to support that the addition of specific ingredients did not raise different questions of public health, a lack of information about the design of the product, and incomplete test data.”

Furthermore, the FDA revealed 136 substantial equivalence applications had been withdrawn at the request of the applicants. According to Bloomberg, the agency had initially received 500 requests for approval from tobacco companies.

“Today’s decisions are just the first of many forthcoming product review actions to be issued,” said Mitch Zeller, director of the FDA's Center for Tobacco Products. “The FDA is committed to making science-based decisions on all product applications and providing the agency’s scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law.”