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Big Tobacco Sues FDA Over Labeling Requirements

Big Tobacco Sue the FDA Over Labeling Requirements

Does big tobacco have a legal leg to stand on with labeling requirements?

On Tuesday, big tobacco filed suit against FDA over tobacco product labeling, claiming that the agency had overstepped its authority. The lawsuit is in response to a guidance issued in March which requires that tobacco companies submit their labeling changes for approval.

Marlboro, Camel, and Newport cigarettes, all subsidiaries of Altria Group Inc., Reynolds-American Inc. and Lorillard Inc., have come together in a lawsuit arguing that the Tobacco Control Act, which initially gave FDA authority to regulate the industry, gave limited control over labeling. FDA said that it does not comment on lawsuits.

“We disagree that FDA’s new requirements that manufacturers must obtain agency authorization before changing certain product labels when the actual physical tobacco product remains exactly the same,” said Brian May, an Altria spokesman to Morningstar News. “We’re asking the court to resolve these issues so that we and other manufacturers know how to proceed.”

Big tobacco says that the labeling requirements could be something as minor as a color or logo change.

According to The Consumerist:

The plaintiff tobacco companies contend that, even though the guidelines are not legally binding, following them has the effect of locking manufacturers into all existing packaging designs or opens them up to financial and legal costs if they make changes.

The industry contends that FDA has a right to regulate labeling changes that present a lower risk to the smoker, while not regulating all labeling. Such requirements would be in violation of big tobacco’s First Amendment Rights.

In its latest guidance, FDA said that it wanted premarket approval of any new tobacco products and it considered new labeling to be part of that guidance. According to FDA:

FDA does conclude, however, that if a product’s label is modified in any way that renders the product distinct from the predicate, even if its characteristics remain the same, the modified product is a new product under section 910(a)(1)(A) of the FD&C Act because that product was not commercially marketed in the United States as of February 15, 2007.

The 2009 Family Smoking Prevention and Tobacco Control Act requires that a pictorial warning label cover 50 percent of the back panel of a cigarette box. The new labels have been found to effectively inform smokers of the impact that cigarettes can have on their health. Those that regularly smoke are also constantly exposed to the warning labels. Furthermore, the warning labels help create the image that not smoking is the norm and that smoking presents an unnecessary risk to consumers. This is a good thing considering that there are still 43.8 million smokers in the U.S. and half of them will die prematurely as a result of their addiction. It’s a label that is in fact incredibly accurate and conveys the risk at hand for those that choose to smoke cigarettes.

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Image of a tobacco box from Shuttershock

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