For more than 5 years, the FDA has had authority to regulate tobacco products, and last month, the agency issued guidance to the tobacco industry about when cigarette makers must seek FDA approval on changes to packaging. The country’s largest tobacco businesses now believe the FDA is overstepping its authority and violates their rights to free expression.

Subsidiaries of tobacco giants Altria, Reynolds American, and Lorillard (which is being bought by Reynolds) filed suit against the FDA on Tuesday in a U.S. District Court in Washington, D.C.

At issue is the March 4 guidance document [PDF] issued by the FDA to clarify when and how cigarette makers would need to seek approval on new products and product changes.

For new products, tobacco companies have to either go through the premarket approval process with the FDA or demonstrate that the new product is “substantially equivalent” to one already on the market. There are also expedited review processes available for products with minor modifications to their contents.

The guidance that the tobacco companies have an issue with is under the heading of “Label Changes,” in which the FDA explains 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.”

This could mean something as minor — in general marketing terms — as a change in color or logo, according to this chart from the guidance document:

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.

They contend that the law does not grant the FDA the authority to prevent cigarette companies from making changes to their packaging. Their understanding of the law is that the FDA is limited to reviewing label changes to products that claim to present a lower risk to the smoker. To the plaintiffs, the conditions spelled out in the guidance document are a violation of their First Amendment rights.

“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,” an Altria rep tells the Wall Street Journal. “We’re asking the court to resolve these issues so that we and other manufacturers know how to proceed.”

Tobacco companies sue FDA to block guidelines [AP]

Tobacco companies sue U.S. FDA over label approvals [Reuters]

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