Tobacco Products Must Be Reviewed By FDA

RICHMOND, Va. — The Food and Drug Administration says it must review tobacco products that were introduced or changed over the last four years in order for companies to keep selling them.

The agency on Wednesday issued guidance to the tobacco industry outlining how to apply for review.

Tobacco makers have until March 22 to prove that the cigarettes or other tobacco products are "substantially equivalent" to ones commercially available before Feb. 15, 2007. That means the ingredients and design are similar and do not raise different public health concerns.

The FDA said it may deny an application if the product poses an increased health risk to users or causes nonusers to start using tobacco.

Companies planning to introduce new products after the March deadline must get approval from the FDA in the form of a market order before they can be sold.

Officials say the requirements are part of a 2009 law giving the FDA the ability to regulate tobacco. They are meant to ensure that new tobacco products are evaluated by the FDA before they are allowed to enter the marketplace.

"Up till now tobacco products had been the only mass-consumed products for which users do not know what they're consuming," Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products, said in a conference call. "No longer will changes to products consumed by millions of Americans be made without anyone knowing."

Still, Deyton warned that "no known existing tobacco product is safe," and FDA approval for a company to sell the product does not make it safe.

"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," he said.

The agency estimates that, under its definition, about 230 new products are introduced every year – a number it expects will continue going forward, according to its submissions in the Federal Register. But, the FDA said, additional regulation may lead tobacco makers to slow that number in the future.

Wednesday's move can be characterized as "largely procedural," Stifel Nicolaus analyst Christopher Growe said in a note to investors. "The FDA took this opportunity to take a proactive approach toward helping industry participants better understand the requirements of the law."

The FDA won the authority in 2009 to regulate tobacco products, including the ability to ban certain products, regulate marketing, reduce nicotine in tobacco products and block labels such "low tar" and "light." Tobacco companies also will be required to cover their cartons with large, graphic warnings.

About 46 million Americans – one out of every five – smoke, and about 3 percent of American adults use smokeless tobacco, according to the Centers for Disease Control and Prevention. Tobacco use in the U.S. also is responsible for about 443,000 deaths per year.

Comments

[Js420]

09:54 PM on 01/06/2011

Good. its about time. Big T has been poisoning people for too long

[Laurence Girard]

01:37 PM on 01/05/2011

I think it's great that the FDA is starting to take a stand on what's going into people's body's. A lot of people smoke tobacco and know it's bad for them, but they don't know WHY it's bad for them. The FDA needs to do a better job at educating consumers about what's going into their body. We started doing a better job by putting warning labels on cigarettes, but people still don't seem to care. Now we need the FDA to put warning signs on the wrappers of Triple Whoppers at Burger King for trans fats. That would be a step in the right direction. I think it's great that the FDA is taking a stand on smoking, but the real thing they need to take a stand on is the amount of saturated fat, trans fats and sodium in our food supply, That's an even bigger tragedy because some people don't even realize how much nutrition affects their health, but the majority of smokers understand it's bad for them at least to some extent. Personally I think we should do everything we can to increase the cost of cigarettes and tobacco so people stop smoking them. The health affects are so bad it's crazy. It increases the risk for almost every disease. I wrote an article on my blog that talks about the negative health affects of smoking, check it out. Here it is -> http://applebananacoconut.com/the-negative-health-effects-of-smoking
Laurence
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