FDA

Texas Cigar Groups Asks Court to Delay FDA Warning Label Requirements

Texas Cigar Groups Asks Court to Delay FDA Warning Label Requirements

By: Charlie Minato


 Halfwheel

Another lawsuit is asking another court to delay the implementation of warning labels on cigar boxes until after the U.S. Food & Drug Administration (FDA) finalizes its evaluation of premium cigars.

Last week, attorneys for En Fuego, a Dallas-area retailer; El Cubano Cigars, a League City-based manufacturer and retailer; and the Texas Cigar Merchants Association (TXCMA) filed a motion for summary judgment which would delay the effective date for warning labels as required by FDA’s deeming regulations.

The plaintiffs are asking for the U.S. District Court for the Eastern District of Texas to make a ruling either before Memorial Day, May 28; or to grant a preliminary injunction—delaying the warning labels—until the Court can decide the manner.

Warning label requirements are scheduled to go into effect on Aug. 10, 2018. Manufacturers would be required to place two warning labels, covering at least 30 percent of two “primary” panels, on cigar boxes beginning that date.

This is the second such legal motion in the same week, following a similar request for attorneys in the Washington D.C.-based lawsuit against FDA brought on by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR).

The primary arguments in the En Fuego et al. case are that the warning label requirements—and the process FDA went about deciding said requirements—is a violation of various laws including the first amendment and the Administrative Procedure Act, (APA) a law which requires the government to go through certain steps before introducing new laws.

In the new motion, the plaintiffs focus on the ideas that FDA’s decision to issue Advanced Notice of Proposed Rulemaking (ANPRM) seeking further comment and data about whether it should regulate premium cigars shows FDA didn’t follow the guidelines set forth by the Supreme Court and the APA.

Like the Washington D.C. case, attorneys argue that FDA got ahead of itself by announcing rules in 2016 and then waiting until 2018 to finalize whether it has the data to show that premium cigars should be regulated per FDA’s mandate.

In addition, the Texas motion argues repetitively that premium cigars are different from mass market cigars and cigarettes, which are the main targets of FDA regulation.

Interestingly, the motion also argues that FDA’s broad descriptions of what constitutes “advertising” create First Amendment violations.

As per FDA rules, all cigar advertising will be subject to not only warning labels, but a warning plan. In the warning plan, manufacturers and retailers will be required to submit a document indicating their advertising intentions for the upcoming 12 months and which warning labels will be used for the specific ads.

The warning label plans are required under the guise that FDA wants to ensure that manufacturers and retailers are rotating the five required warning messages evenly throughout perspective advertising.

FDA has not defined advertising, but it did mention where it believes advertising could take place:

Promotional materials (point-of-sale or non-point-of-sale), billboards, posters, placards, published journals, newspapers, magazines, other periodicals, catalogues, leaflets, brochures, direct mail, shelf-talkers, display racks, Internet Web pages, television, electronic mail correspondence, and also include those communicated via mobile telephone, smartphone, microblog, social media Web site, or other communication tool; Web sites, applications, or other programs that allow for the sharing of audio, video, or photography files; video and audio promotions; and items not subject to the sale or distribution ban in § 1140.34.

The broadness of the descriptions is likely due to the fact that other tobacco products which FDA regulates—namely cigarettes and smokeless tobacco—have been subject to a multitude of other advertising regulations for decades. Those rules have developed through a web of Congressional regulation, court rulings and settlements; namely, not by FDA.

In addition, there are regulations about selling cigarettes and smokeless tobacco, particularly an effective ban on online sales.

As such, this marks FDA’s first real attempt at regulating tobacco advertising and as such—not surprisingly—it’s extremely ambigious and without direct examples of what it looks like in the real world.

“Under the Rule, a small business like En Fuego or El Cubano that one day wishes to announce to the public that it has a particular cigar for sale at a particular price cannot just speak; it must wait twelve months,” argues the lawsuit.

It goes further to indicate it would place unrealistic burdens on a retailer, who likely doesn’t know what products it will have in stock in 12 months, let alone what products it wants to put on sale.

In a separate filing this week, attorneys responded to a motion from attorneys for FDA that seeks to combine the Washington D.C. and Texas lawsuits into one.

The plaintiffs in the En Fuego et al. case seek to keep their lawsuit separate, arguing that neither En Fuego or El Cubano are currently members of IPCPR and that the cases are not identical, namely that the Cigar Association of America, one of the D.C. plaintiffs, represents the interest of companies that are not the same of the plaintiffs of the Texas case.

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