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F.D.A Bans 4 Cigarette Products Produced by R.J. Reynolds (New York Times, Sabrina Tavernise)

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On September 15, 2015 The New York Times reported that the U.S. Food & Drug Administration (FDA) issued “Not Substantially Equivalent” (NSE) orders to stop the sale and distribution of four new cigarette products produced by R.J Reynolds because these four products are not “substantially equivalent” to products marketed as of February 15, 2007).  These four products include Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. The FDA banned the sale of these four products under the authority of a 2009 law summarized below by the New York Times:

  • “Under a 2009 federal law called the Family Smoking Prevention and Tobacco Control Act of 2009,, the FDA. can reject cigarettes and other tobacco products that its scientists believe pose greater public health risks than comparable products already on the market, a sharp departure from past practice, when tobacco companies could change existing products and introduce new ones at will.
  • These four products were introduced during a grace period set up by the law. R.J.R. applied for so-called “substantial equivalence” status at that time. To be considered “substantially equivalent,” tobacco products must be shown to have the same characteristics as a predecessor product, or to have different ones that do not raise new questions for public health. Over the past two years, the agency has blocked products that were not the same as predecessors on a number of occasions.
  • The products had higher amounts of harmful ingredients, higher levels of menthol, or the addition of new ingredients that raised new questions for public health.”
  • The FDA’s NSA orders require removal from the market, and it is illegal to sell or distribute the product in interstate commerce.  Any company selling these products will have 30 days after September 15, 2015 to dispose of the products or face financial penalties or criminal prosecution.

The policy does not apply to inventory purchased by retailers after the date of the order.