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WASHINGTON, D.C. — The Food and Drug Administration's (FDA) deeming rule is coming under fire from cigar and tobacco associations.
The Cigar Association of America, International Premium Cigar and Pipe Retailers Association and the Cigar Rights of America have asked the U.S. District Court in the District of Columbia for a declaratory injunction "vacate, set aside and enjoin the enforcement of the final rule."
The groups argue the rule — set to go into effect Aug. 8 — violates numerous federal statutes as well as the federal rulemaking process.
"Just over one month ago, our three associations pledged to work together to develop the appropriate response to the FDA's new deeming rule. After a thorough and detailed legal review, we are challenging this unlawful regulatory action in federal court to protect the statutory and constitutional rights of our industry and its members. The fact that all three of our organizations are acting in once voice speaks to the urgency and seriousness of this action," said Mark Pursell, CEO of the International Premium Cigar and Pipe Retailers Association.
According to the associations, the complaint challenges:
- FDA's improper application of the Feb. 15, 2007 grandfather date to cigars and pipe tobacco
- FDA's assessment of a tax in the form of user fees, and its allocation of these user fees only to cigars and pipe tobacco and not to other newly deemed products
- FDA's failure to perform an adequate cost-benefit analysis to take into account the effects of the final deeming rule on small businesses as is required by the Regulatory Flexibility Act
- FDA's decision to require cigar health warning labels to be 30 percent of the two principal display panels of packages
- FDA's designation of tobacconists who blend finished pipe tobacco or create cigar samplers of finished cigars as "manufacturers," which subjects those businesses to greater regulation than if they were "retailers"
- FDA's decision to regulate pipes as "components" or "parts" rather than as "accessories"
"The FDA ignored the law to craft these expansive and sweeping regulations and cannot justify many of the arbitrary and capricious regulations it purports to enact," said Glynn Loope, executive director of Cigar Rights of America. "This lawsuit is a specific and detailed challenge to the FDA's unprecedented assertion of rulemaking authority. We are acting in one voice to protect the legal rights of our industry at all levels, from the manufacturer, the community retail tobacconist, to the adult patrons of cigars."
According to Cigar Association of America President Craig Williamson, the associations worked in "good faith" to educate the agency about what makes the cigar industry unique.
"We hoped the FDA would craft a flexible regulatory structure that accounted for the uniqueness of our industry. Instead, we got a broad, one-size-fits-all rule that fails to account for how cigars and premium cigars are manufactured, distributed, sold and consumed in the United States," he said.
Other Legal Challenges
The legal challenge by these associations is just the latest suit against the FDA over the deeming rule, which expands the agency the authority to regulate all tobacco products, including electronic cigarettes, cigars, hookah tobacco and pipe tobacco.
As CSNews Online previously reported, the Right to be Smoke-Free Coalition and nine other groups filed a complaint at the end of June against the FDA, FDA Commissioner of Food and Drugs Robert Califf and Secretary of Health and Human Services Sylvia Burwell.
A federal district court judge in Washington, D.C., ordered the case to be consolidated with another lawsuit challenging the agency rules brought by Nicopure Labs LLC, the news outlet reported.
Judge Amy Berman Jackson set an Aug. 16 deadline for the FDA to respond to the lawsuits and scheduled a hearing for Oct. 19.
The Altria Group Inc. filed a lawsuit against the against the agency's latest regulation prohibiting the use of the term "mild" in tobacco products. Altria's operating company John Middleton Co.'s product lineup include the Black & Mild cigar brand.
In another challenge, Lost Art Liquids LLC filed a lawsuit against the FDA in the U.S. District Court for the Central District of California. The California-based company claims the FDA failed to consider the impact its rule would have on small businesses in violation of the Regulatory Flexibility Act.
Larry Faircloth, a Republican in the West Virginia House of Delegates and e-cigarette user, is also suing the agency over the rules. In this suit, filed in the federal district court for the southern district of West Virginia, Faircloth claims he used e-cigarettes and other vaping devices to quit smoking and will "likely return to the unhealthy habit of using tobacco products" as a result of the rule.