WASHINGTON – The major tobacco companies have filed a lawsuit against the U.S. Food & Drug Administration (FDA), challenging its effort under the Family Smoking Prevention & Tobacco Control Act (TCA) “to assert a broad power of prior restraint over [the tobacco companies’] marketing communications”—namely, over labels on tobacco-product packaging.
In court documents, the companies assert that the TCA “plainly denies FDA that power and the First Amendment bars it.”
Richmond, Va.-based Altria Group Inc.’s Philip Morris USA Inc. and U.S. Smokeless Tobacco Co. LLC; Winston-Salem, N.C.-based Reynolds American Inc.’s R.J. Reynolds Tobacco Co. Inc., Santa Fe Natural Tobacco Co. Inc. and American Snuff Co.; and Greensboro, N.C.-based Lorillard Inc.’s Lorillard Tobacco Co. filed the lawsuit in the U.S. District Court for the District of Columbia on April 14.
For tobacco-product labels, Congress rejected giving the FDA power to pre-approve changes except in two circumstances--where the label makes a “modified-risk” claim; and where the FDA adopts a specific pre-approval regulation through notice-and-comment rulemaking.
On March 4, 2015, the FDA issued Guidance for Industry: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. The companies allege that this SE Directive “disregarded Congress’s carefully calibrated statutory framework” and is “contrary to the TCA, exceeds the authority Congress delegated to FDA under the statute, lacks any reasoned or reasonable justification and provides inadequate notice to manufacturers about which label changes will trigger FDA’s new regulatory requirements, the SE Directive is arbitrary and capricious, an abuse of discretion, not in accordance of law, and in excess of statutory jurisdiction, authority and limitation. … By failing to engage in notice-and-comment rulemaking, FDA [violated] the TCA.”
The companies also assert that the SE Directive “violates the First Amendment’s strict limitations on prior restraints as well as its protections for commercial speech and the prohibition against vague speech restrictions.”
“We disagree with 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,” Altria spokesperson Brian May told CSP Daily News. “We are also challenging similar requirements with respect to the quantity of a tobacco product in a package. In addition, when Congress enacted the [TCA], it expressly prohibited FDA from requiring a pre-authorization for labels, except by formal regulation. The FDA did not follow this process. We’re asking the court to resolve these issues so that we and other manufacturers know how to proceed.”
“We believe RAI’s tobacco operating companies are in compliance with the [TCA]. RAI and its operating companies, however, believe that the FDA does not have the authority to impose the restrictions outlined in the guidance it issued on March 3, 2015, which claims that FDA approval is required for changes to labeling of tobacco products and the quantities of products within a package," David Howard, spokesperson for Reynolds American, told CSP Daily News. "The [TCA] regulates the introduction of new tobacco products into the market. But changes to the label or the quantity of products sold do not change the product itself—and, thus, do not create a 'new' tobacco product. Indeed, the FDA has conceded as much. Consequently, the guidance is directly contrary to the [TCA]."
He added, "The guidance violates the companies’ First Amendment rights to communicate accurate, truthful information to adult tobacco consumers. Manufacturers have a First Amendment right to engage in truthful, non-misleading speech on their packages. The guidance, however, restricts manufacturers from engaging in such protected speech unless the FDA first reviews and clears it. The First Amendment prohibits that type of censorship.”
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