Newer tobacco products to face FDA review
WASHINGTON (Reuters) - Cigarette makers will have to provide U.S. regulators with detailed information about the ingredients and design of products they have introduced or changed since early 2007, or face possible penalties.
In new rules for the industry, the U.S. Food and Drug Administration is implementing provisions of a law enacted last year on how companies can show new or modified cigarettes and other tobacco products are not more harmful than those sold before February 15, 2007.
The multi-billion tobacco industry, which largely fought the law, has known about the requirements for almost a year, but Wednesday's announcement gives companies clear deadlines and specific details to attend to.
The move aims to shed light on levels of addictive nicotine and other properties of cigarettes, smokeless tobacco and roll-your-own products to keep more dangerous products off the market, officials said. It does not target cigars or dissolvable tobacco products.
The changes will "assure that any new or changed tobacco products are not worse to the public health than those that were on the market February 15, 2007," said Lawrence Deyton, head of the FDA's new Center for Tobacco Products.
Roughly one in five American adults, or 46.6 million people, smoke cigarettes according to the U.S. Centers for Disease Control and Prevention.
The February cut-off was set in the 2009 law, which granted the FDA power to regulate the controversial industry. The most prominent U.S. tobacco companies are Altria Group Inc, Reynolds American Inc and Lorillard Inc.
Manufacturers must file reports detailing their products to FDA by March 22 in order to keep selling them. Those that do can have additional time to add more information, the FDA said.
Tobacco companies that do not comply risk product seizures, injunctions and other penalties.
The FDA will review submissions, and any products not considered equivalent to ones on the market as of February 2007 may be prohibited from sale, officials said.
David Howard, spokesman for Reynolds's R.J. Reynolds Tobacco Co, said the company has already submitted several applications for the FDA to review and expected to meet the March deadline for its products.
Altria spokesman Steve Callahan said his company -- the only one to back the tobacco law -- was reviewing the guidelines. Lorillard had no comment.
Shares of tobacco companies initially were down less than 1 percent before later recovering. Altria, Reynolds, and Lorillard closed up less than 1 percent, roughly in line with the overall S&P index. Vector Group ended 1.3 percent higher.
Advocates who pushed for FDA oversight said the new standards ensure that tobacco companies submit product changes in advance just as drug and device companies do.
"Until now, they've been able to make changes that have increased the risk of disease, increased the addictive nature of product, and increased the appeal of the product in secret," Matthew Myers, president of Campaign for Tobacco-Free Kids, told Reuters.
(Additional reporting by Lisa Richwine in Washington and Ben Klayman in Detroit; Editing by Derek Caney, Steve Orlofsky and Bernard Orr)
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