The Food and Drug Administration has targeted four cigarette products, including Camel and Pall Mall brands, for not meeting regulations, the latest companies to get ensnared in a burgeoning agency dragnet.
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The other products include Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.
The agency acted under a key provision of the law that requires prior FDA review and authorization before tobacco companies market new or changed products. Not only were the products’ characteristics different, the FDA said R.J. Reynolds failed to show that the new products would not raise different public health concerns.
R.J. Reynolds did not immediately respond to a request for comment from NBC.
The agency received the authority to regulate tobacco products in 2009. As a result, the four products may no longer be distributed or sold in the U.S.
Mitch Zeller, director of the FDA’s tobacco division, told reporters on a conference call that the Reynolds products included increased yields of harmful or potentially harmful constituents, higher levels of menthol and the addition of new ingredients. FDA doesn’t want to be seen “approving” a tobacco product, but can refuse an application to market something new.
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. The company could not show that the changes do not raise new health questions, he said.
Per the press release, “When the FDA issues an NSE order, the tobacco product in inventory, including at a retail location, becomes adulterated and misbranded”.
“We commend FDA for taking this action”, said David Willoughby, Chief Executive Officer of ClearWay Minnesota. However, the agency said it will not take action for 30 days to give stores and distributors time to dispose of the products.
“Today’s decision sets an important precedent that nearly certainly will apply to other brands”.
The same law grants the FDA the right to ban tobacco products that pose greater health risks than predicate products. We authorize them for marketing.
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Reynolds American said it is working to determine its plan of action in light of the FDA’s declaration.
