Lawsuits Accumulating Against FDA's Deeming Rule

WASHINGTON, D.C. — Two months since the Food and Drug Administration (FDA) finalized the deeming rule — and less than one month before it goes into effect — the legal challenges keep rolling in.

The deeming rule expands the agency the authority to regulate all tobacco products, including electronic cigarettes, cigars, hookah tobacco and pipe tobacco. It goes into effect Aug. 8.

According to The Hill, as many as five lawsuits have been filed against the agency over the regulations included in the new rule. One of the most debated regulations is the Feb. 15, 2007 grandfather date for all newly deemed products.

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.

Similar to Nicopure's objections, the groups — including the American Vaping Association and the Electronic Vaping Coalition — contend the deeming rule violates the First Amendment because it bans companies from passing out free samples, which it claims is a protected form of non-misleading speech.

The groups also claim it was "unlawful and unreasonable" under the Administrative Procedures Act for the FDA to include electronic nicotine delivery systems (ENDS) under the 2009 Family Smoking Prevention and Tobacco Control Act's definition of a "tobacco product," the report added.

"FDA intends to regulate these products despite the fact that they do not contain tobacco, are not derived from tobacco, and are not components or parts of an actual tobacco product," they said in court documents. "The agency offers no rationale based on the definition of 'tobacco product' or the legislative history indicating that such definition can be stretched so far as to capture these types of ENDS products merely because they are used to consume a tobacco product."

Judge Amy Berman Jackson set an Aug. 16 deadline for the FDA to respond to the lawsuits and scheduled a hearing for Oct. 19.

In addition, in late May, 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. Included in the final deeming rule is a requirement that manufacturers, importers and/or retailers cannot sell modified risk tobacco products — including those described as "light," "low" or "mild" — unless authorized by the agency, as CSNews Online previously reported.

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. (RFA), according to The Hill.

"Rather than focus on the overall costs and benefits of a particular regulation, the RFA requires the agency to undertake an analysis that determines the impacts of the rule on small entities and then considers alternatives that reduce or minimize those impacts," the company said in the complaint

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, the report added.

Faircloth's complaint asks the court to toss out the FDA rule.

FDA Spokesman Michael Felberbaum told the news outlet the agency does not comment on pending litigation.