Judge Upholds FDA Warnings on Cigars

Lawsuit ruling a mixed bag of news for manufacturers and retailers

WASHINGTON -- A U.S. District Court judge has ruled in favor of the U.S. Food and Drug Administration’s (FDA's) right to require new cigar health-statement warnings on product packaging and advertisements, according to court documents.

Judge Amit Mehta of the U.S. District Court of the District of Columbia said the FDA has authority under its deeming regulations to require warning labels and that its actions are constitutional.

Parsing the Decision

The May 18 decision stemmed from a 2016 lawsuit brought by three Washington, D.C.-based cigar trade organizations—the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America—that challenged several key aspects of the FDA’s regulations.

The decision also upheld the FDA’s authority to assess a user fee to cover its operating costs. However, while the fee can apply to cigarettes, roll-your-own tobacco, smokeless tobacco, cigars and pipe tobacco, the rule does not extend to manufacturers of electronic cigarettes.

The news was better for retailers that blend different pipe tobaccos together to create a new flavor of pipe tobacco, according to Lakeville, Minn.-based tobacco-retailing association NATO, because the judge said the way the FDA defined such retailers violated the federal Administrative Procedures Act. The court remanded the issue to the FDA, which means the court sent the issue back to the FDA for further consideration, NATO officials said.

Although the federal court upheld the health warnings for cigars, the judge urged the agency not to proceed with implementing the warnings, NATO said. Specifically, the judge wrote that “requiring the premium-cigar industry to incur substantial compliance costs while the agency comprehensively reassesses the wisdom of regulation, before the warnings requirements go into effect, smacks of basic unfairness. In the court’s view, the prudent course would be for the FDA to stay the warnings requirement as to premium cigars.”

Other issues remain outstanding in the litigation, NATO said. As such, the parties are scheduled to meet in June with the court to determine how to proceed.

A New Grandfather Date

In other cigar news, members of the U.S. House Appropriations Committee voted 29-20 in May to add a revised version of the Cole-Bishop Amendment to the Agriculture and Rural Development Appropriations bill. The new version, among other things, would change the agency’s predicate date (or “grandfather date”) for cigars and pipe tobacco as it pertains to its deeming regulations.

If signed into law, the change means cigars and pipe-tobacco products that were on the market as of Aug. 8, 2016, can remain on the market without the need for manufacturers to file either a substantial equivalency or premarket tobacco application with the FDA just to remain on the market.

Such application requirements apply to tobacco products that were on the market as of Feb. 15, 2007, which is the original predicate date. Moving that threshold into 2016 would mean a substantial number of products would forgo the time and expense of the application process.

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