Tobacco manufacturers must report ingredients to FDA
Source: www2.journalnow.com Author: Richard Craver The Food and Drug Administration is giving tobacco manufacturers less than three months to provide proof that any product introduced since February 2007 is "substantially equivalent" to products already in the marketplace. If a manufacturer does not file a report by March 22, or cannot substantiate its evidence, the FDA said Wednesday that it could remove the product from store shelves. The announcement updated the guidance provided to manufacturers in June 2009 as part of enacting the Family Smoking Prevention and Tobacco Control Act. Manufacturers of any product introduced after March 22 must submit an application and obtain a marketing order from the FDA before placing the product on the market. The emphasis of the new rules puts R.J. Reynolds Tobacco Co. in the bull's-eye because it has been the most prolific developer of tobacco products in recent years, including Camel Snus and the Camel orbs, sticks and filmlike strips for the tongue. "No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such," said Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products. "These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products." The FDA defined "substantially equivalent" as "being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single-predicate [...]