Jan. 5, 2011 – Makers of tobacco products that have been changed since Feb. 15, 2007, must show the "new" products are no worse for public health or see the products banned in the U.S., the FDA today ruled.
The rule applies to cigarettes, smokeless tobacco products, and roll-your-own tobacco products. It does not apply to electronic cigarettes (e-cigarettes). Tobacco companies have until March 22, 2011, to submit evidence to the FDA that new or changed products are "substantially equivalent" to those made before February 2007.
Authority for the rule -- and the Feb. 15, 2007, "grandfather" date -- comes from the Tobacco Control Act of June 2009, Lawrence R. Deyton, MD, MPH, director of the FDA's Center for Tobacco Products, said at a news conference.
"This law requires the FDA to carefully consider what impact these changes or new products have on the public health," Deyton said. "No longer will changes to products consumed by millions of Americans be made without anyone knowing."
Deyton noted that tobacco companies have never before had to tell the FDA what was in their products. They still don't -- unless they want to sell a new product, or one that was altered since February 2007.
In that case, the company must present detailed evidence that the new product is no worse for the public health than the old product. Presumably this will mean telling the FDA exactly what is in the old and new products, and how they are made.
"Up until now, tobacco products have been the only products consumed by millions for which users do not know what they are consuming, because manufacturers frequently alter ingredients without anyone knowing," Deyton said.
New or Changed Tobacco Products Could Be Banned
According to the ruling, products are considered modified if they have "a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient."
To be considered unchanged, the company must show that the new or altered product is no more toxic, addictive, or attractive to minors than similar products made before February 2007. A senior company official such as the CEO must sign a letter certifying that changes to the product will not have these effects.
So what happens to tobacco products if the FDA determines they are not equivalent to grandfathered products?
"The law allows those products not found to be equivalent to be withdrawn from the public market If the changes raise different questions of public health," Deyton said. "The intent is to assure that no new or changed tobacco products are worse for public health than those already on the market on Feb. 15, 2007."
This doesn't mean the new products are healthier than the old products -- although Deyton says tobacco companies are encouraged to make safer products.
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.