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FDA gives smokeless tobacco product a pass

Chicago White Sox designated hitter Manny Ramirez puts chewing tobacco in his mouth before a baseball game against the Cleveland Indians at Progressive Field in Cleveland on August 31, 2010. UPI/David Richard
Chicago White Sox designated hitter Manny Ramirez puts chewing tobacco in his mouth before a baseball game against the Cleveland Indians at Progressive Field in Cleveland on August 31, 2010. UPI/David Richard | License Photo

WASHINGTON, March 25 (UPI) -- An executive at Star Scientific said the firm was surprised its smokeless tobacco lozenges were not subject to FDA regulation.

"We were very surprised. We obviously believed that these were smokeless tobacco products under the act," Troy Machir, the firm's vice president for communications and investor relations, told the Los Angeles Times.

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The firm had asked the Food and Drug Administration if it could market Ariva-BDL and Stonewall-BDL as "modified risk" products under the 2009 tobacco law. But the FDA in a confidential ruling said the products were not covered by the law at all.

Matt Myers at the Campaign for Tobacco-Free Kids said the decision "creates unnecessary uncertainty and the potential for widespread abuse" among makers of smokeless tobacco products.

Some fear other producers of smokeless tobacco products will apply for exemptions under the new law.

Spokesmen for RJ Reynolds and Philip Morris USA, both of which make smokeless tobacco products, declined to comment, the Times said.

The FDA said in a statement there are "uncertainties regarding the regulatory status of a variety of nicotine-containing products."

The FDA said it is "considering its legal and regulatory options regarding these products."

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