Tobacco Company Lawsuit Alleges FDA Overstepping Authority

Tobacco Company Lawsuit Alleges FDA Overstepping Authority

This Tuesday, July 15, 2014 photo shows the tobacco in cigarettes in Philadelphia. A study ties a host of new diseases to smoking, and says an additional 60,000 to 120,000 deaths each year in the United States are probably due to tobacco use. The study by the American Cancer Society and several universities is published in the Thursday, Feb 12, 2015 edition of the New England Journal of Medicine. It looks beyond lung cancer, heart disease and other conditions already tied to smoking and adds breast cancer, prostate cancer and even routine infections to the list. (AP Photo/Matt Rourke)
This Tuesday, July 15, 2014 photo shows the tobacco in cigarettes in Philadelphia. A study ties a host of new diseases to smoking, and says an additional 60,000 to 120,000 deaths each year in the United States are probably due to tobacco use. (AP Photo/Matt Rourke)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The nation’s largest tobacco companies are suing the Food and Drug Administration over recent guidelines that they claim overstep the agency’s authority over labeling and packaging for cigarettes and other tobacco products.

Units of R.J. Reynolds Tobacco, Altria Group Inc. and Lorillard Tobacco filed the lawsuit Tuesday in the U.S. District Court for the District of Columbia, claiming the FDA’s guidance infringes on their commercial speech.

The FDA gained authority to regulate tobacco in 2009, including the power to pre-review new tobacco products that are significantly different from older ones already on the market.

Last month the agency issued guidelines intended to help manufacturers determine which new products require FDA review.

But the tobacco makers allege that the FDA is asserting overly-broad authority to approve or deny any labeling change that would make a product “distinct.” Their lawsuit argues that the FDA only has prior-review authority for labels on tobacco products claiming to represent a “modified risk,” or to be less harmful than other tobacco products.

FDA guidelines are considered suggestions and are not legally binding. But the tobacco companies say the FDA document “creates specific legal obligations with clear and draconian consequences for violations.”

The FDA said it does not comment on litigation.

The agency issued a draft version of the guidelines in September 2011 and took comments from industry and the public on the proposal.

In an explanation accompanying the final guidelines issued last month, the FDA said that certain labeling changes effectively create a new product “if consumers are likely to perceive it as ‘new’ by virtue of the different label.” Regulators listed examples such as changing a product’s logo, packaging color or product description.

The U.S. tobacco industry has repeatedly challenged FDA authority in court since Congress passed the Tobacco Control Act of 2009.

In 2011, some of the industry’s largest companies sued the FDA to block an order that would have required cigarette packages to carry large, graphic warning labels illustrating the dangers of smoking. But an appeals court decision ruled that the labels violated the First Amendment’s free speech protections and the government abandoned the plan in 2013.

Tobacco companies rely on their packaging to build brand loyalty and grab consumers. It’s one of few advertising levers left to them after the government curbed their presence in magazines, billboards and TV.

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