According to the report by Reuters, FDA’s rulings against the four cigarette brands were because they were different than their predecessor brands which made the agency question the safety of the products.
Under FDA rules, companies that launch introduce new cigarettes must show that the products are essentially the same as older products in terms of health risks.
Agency officials said they participated in a “considerable back and forth” with North Carolina-based R.J. Reynolds before ordering the cigarettes off the market. As part of the provisional period, the company had to submit a substantial equivalence (SE) application to the FDA by March 22, 2011, in order for the products to remain on the market. Matthew Grainger, a tobacco analyst at Morgan Stanley sees the move a: “It could potentially mark a slight uptick in its willingness to utilize its regulatory authority and to more explicitly use its “population health” standard as a tool” to reduce the proliferation of new products.
The agency received the authority to regulate tobacco products in 2009.
Responding to the FDA decision, R.J. Reynolds Tobacco Company, an indirect subsidiary of Reynolds American Inc.
Zeller said that all four cigarette products have different characteristics than the comparison cigarettes that preceded them.
Retailers will have 30 days from Wednesday of this week to make arrangements to dispose of their inventory of the banned products before the FDA will begin enforcing the order.
Today’s decision sets an important precedent that nearly certainly will apply to other brands.
That “raised questions for us”, said Mitch Zeller, director of FDA’s Center for Tobacco Products. The RJR Tobacco segment consists primarily of the primary operations of R. J. Reynolds Tobacco Company.
Puskar/APPackages of Camel Crush Bold and other Camel brand cigarettes on display at a shop in Pittsburgh.
In this latest action the agency expressed concern the cigarette products were changed with no notice, making them different from their previous approved versions.
Instead, the brands contain ingredients that were not in the comparison products, and those that were contained higher levels, the agency said in a release. The Campaign for Tobacco-Free Kids has brought to the FDA’s attention several products that we believe are being marketed in violation of the law.
Anti-tobacco campaigners have long wanted restrictions on innovative menthol products like Camel Crush, which they argue are more appealing to consumers and encourages smoking among teenagers.