FDA Requires Tobacco Companies on New Ingredient Rules

Published on February 3rd, 2011 12:34

In a few months, all tobacco manufacturers will have to inform the Food and Drug Administration (FDA) about their new additives and other changes in the majority of their products, thus allowing the agency to eradicate ingredients that make tobacco products more additive and harmful.

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The FDA was appointed to gather information by the 2009 Tobacco Control Act, and a few days ago the agency presented guidance to the tobacco manufacturers about sorts of details it is looking for. “Probably tobacco products are the only wide-scale consumed products in which users do not know exactly what they are consuming,” Lawrence Deyton, director of the FDA’s Center for Tobacco Products, stated in an interview.

Tobacco manufacturers often change the level of nicotine; add new substances in order to make their products more addictive and appealing. Until March 22, tobacco producers have to file their reports. “I think that this action is one of the most effective the FDA undertakes on tobacco regulation. They are going to show down the chemistry, which they never had before,” stated Matthew Myers, president of the Campaign for Tobacco-Free Kids.

In accordance with the statutory reporting, tobacco producers should inform the agency about any new tobacco product introduced into the market or changed within time. And the new product or the changed one should have substantial equivalence to products on the market on February 15, 2007, the date when tobacco legislation was presented in Congress –otherwise they risk to be eliminated from the market.

In case tobacco producers do not obey a substantial-equivalence report, they must exclude their products from the market by March 23, in accordance with the new FDA guidelines.

Tobacco Manufacturers are being asked to unmask the composition of their products before and after a change is made so experts can detach the changes and determine the potential hazard. Those producers who will disclose products after the March deadline should submit an application and receive an FDA market order before starting to sell their products.

Companies that do not obey reporting requirements might face product sequestration, prohibitory injunctions and other penalties. “None of the known tobacco products is safe. All analyzed products will not be safer, but we are obliged by this law not to permit even more dangerous products, which may lead to further harm to those Americans who smoke,” Deyton stated.

Current federal filing shows that approximately 230 new tobacco products are manufactured annually. These reporting obligations should be observed by producers of cigarettes and smokeless tobacco products. It doesn’t refer to other forms of tobacco or to electronic cigarettes. “We are still studying the FDA guidance but have already sent some reports on our products and we hope that we will meet the conditions,” said, David Howard, a spokesman for R.J. Reynolds Tobacco Co.

By Joanna Johnson, Staff Writer. Copyright © 2011 TobaccoPub.com. All rights reserved.

Related tags: tobacco company | new smoking product | big tobacco | tobacco product

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