UPDATE: FDA Says Delaying Tobacco Authority Will Harm Public
October 08 2009 - 2:44PM
Dow Jones News
The U.S. Food and Drug Administration on Thursday will tell a
federal judge in Kentucky that ordering the agency to delay
enforcing new tobacco laws will have "devastating consequences" on
public health.
The FDA is facing a challenge to its new tobacco powers, signed
into law in June, from tobacco companies including Camel cigarette
maker Reynolds American Inc. (RAI) and Commonwealth Brands Inc. The
companies say the law imposes unprecedented restrictions on their
First Amendment rights and want a federal court in Bowling Green,
Ky., to order a preliminary injunction to stop enforcement of
certain provisions in the regulations.
A judge for the District Court for the Western District of
Kentucky is holding a hearing on the preliminary injunction request
and could soon decide whether to grant the injunction.
The law restricts tobacco companies from using color in most
ads, bars them from saying certain products are less risky than
others and stops them from selling tobacco products in combination
with other items, such as soda and mouthwash.
"It is crucial to the public health that tobacco products not be
marketed as reduced-risk products unless they will, in fact, reduce
risks," the FDA said in a brief filed with the court.
The injunction request relates only to the restrictions on
marketing tobacco products with other consumer items, and
restrictions against advertising that a tobacco product is less
risky than other tobacco product. Restrictions on color in ads
don't go into effect until June 2010.
The companies want to be able to make claims in ads and on boxes
that certain tobacco products contain smaller amounts of harmful
ingredients, such as being low in tar, and are, therefore, less
risky than other tobacco products.
This issue is important to companies that make smokeless tobacco
products. Reynolds, for instance, makes Camel Snus, a type of
tobacco that comes in a pouch in flavors like "frost" and
"mellow."
In their briefing documents, the companies argue that such
information is truthful and should be given to consumers.
The FDA says such information gives consumers the "mistaken
belief" that the products are safe to use. The agency will allow
companies to make such claims only after they prove the product
does reduce a consumers risk for tobacco-related diseases. That
appears to be a high hurdle. The agency notes that medical devices
and prescription drugs must go through a rigorous review process
before they can be sold to treat or reduce the risk of disease.
The companies say they aren't completely against the FDA
authority to regulate tobacco, and that they support restrictions
in marketing and advertising to children.
While Lorillard Inc. (LO) is a party to the overall lawsuit
challenging the advertising restrictions imposed by the law, it
isn't a party to the preliminary injunction, according to a company
spokesman. The company says it didn't join the request for
injunction because it doesn't intend to market tobacco products
with claims that they are less risky than other tobacco
products.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com
(Alicia Mundy contributed to this report.)