Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box have different characteristics than the predicate products, but the new products did not raise different questions of public health, FDA officials said.
These are the first products authorized to be marketed since the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the authority to regulate tobacco products.
"Today's decisions are just the first of many forthcoming product review actions to be issued," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a statement. "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."
Zeller took pains to point out once a company receives a substantial equivalence marketing order for a product, it only means the FDA found the new tobacco product is substantially equivalent to a predicate product and in compliance with the requirements of the Federal Food, Drug & Cosmetic Act.
A substantial equivalence marketing order is not a finding that the product it is safe or safer than its predicate product, or less harmful in general -- essentially it says new product is not more harmful than existing products, Zeller said.
In addition, Zeller emphasized the 2009 law made clear tobacco companies cannot say their products are FDA approved.
The agency also said it denied the marketing of four other cigarette products via the substantial equivalence pathway, for reasons 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.
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