FDA Challenges Tobacco Companies
Agency to Ban Tobacco Products Changed for Worse Since February 2007
New or Changed Tobacco Products Could Be Banned continued...
How many products are affected? According to an FDA analysis of new UPC codes for tobacco products, in 2008 alone there were 233 new tobacco products, including 151 new cigarette products and 43 new chewing-tobacco products.
It's up to tobacco companies to tell the FDA whether a product is new or changed since February 2007.
But after March 22, 2011, any product the FDA considers new or changed will be ruled "adulterated" and banned from the market -- unless the company that makes the product has submitted a premarket application to the FDA, shown that the product is substantially equivalent to older products, or applied for an exemption from the new requirements.
"Congress has given us the tools to bring enforcement actions: possible seizures, injunctions, and other types of enforcement against any violative product that is in U.S. commerce," Ann Simoneau, JD, director of compliance and enforcement for the FDA tobacco center, said at the news conference.