Five Lawsuits Filed So Far Against Deeming Regulations

Boston University School of Public Health Prof. Michael Siegel said that since Nicopure Labs last month filed the first legal challenge to the FDA’s new deeming regulations, four more lawsuits have been filed against the agency, all of which, he claimed, present “strong and solid” arguments against the deeming regulations, including that the FDA, by applying the Tobacco Control Act of 2009 to eVapor products, exceeded the “very limited and specific scope of authority” that it was granted by Congress under the Act; the agency failed to conduct a proper cost-benefit analysis; its regulatory scheme lacks a rational basis; and the regulations infringe upon the free speech rights of companies by prohibiting them from making “truthful, non-misleading” claims about their products without any legitimate government interest in doing so. Prof. Siegel said that Lost Art Liquids, LLC has sued the FDA under the Administrative Procedure Act (APA), the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment. “Vapor products are technology products, not tobacco products,” according to Lost Art Liquids’ Co-Founder and COO Ryan Thomas, who said the TCA was created to regulate products like cigarettes and smokeless tobacco products, not eVapor. West Virginia House Del. Larry Faircloth (R-Berkeley) has filed a lawsuit against the FDA under the APA, the First Amendment, and the Tenth Amendment. Faircloth claims, among other things, that the FDA’s ban on new product introductions after August 8, 2016, is “arbitrary and capricious.” Faircloth also contends that the FDA failed to quantify the benefits of the regulation and “grossly” underestimated the costs, pointing out as an example the agency’s estimate that only 750 pre-market tobacco applications would be required, while, in reality, there are single companies that would have to file as many applications alone. Another lawsuit filed by a coalition of eVapor associations, including the Right to Be Smoke-Free Coalition, the American E-Liquid Manufacturing Standards Association, and the American Vaping Association, has challenged the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, the Fifth Amendment, and the Fourteenth Amendment. In addition to making allegations similar to those made in the other lawsuits, this lawsuit also challenges the grandfather date, the pre-market authorization process, the ban on allowing customers to try e-liquid flavors in adult-only vape shops, the application of the “tobacco product” definition to component parts of vaping devices that do not meet that definition, and the entire modified risk clause, Prof. Siegel noted. Altria subsidiary John Middleton, which makes the Black & Mild cigar brand, has filed a lawsuit, claiming that the deeming regulations’ ban on the use of terms such as “light” and “mild” violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents an expropriation of private property without compensation. Altria argues that the Black and Mild brand name, which has been around for more than 40 years, conveys information about the product’s “taste and body,” rather than its safety. Prof. Siegel said that all of these lawsuits are seeking an injunction against enforcement of various aspects of the regulations or seeking to overturn the regulations in their entirety ( 6/27).

For more Michael Siegel analysis review his blog roll on the right side bottom blog roll of the tobacco today site.


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