Monday, June 27, 2016

Four More Lawsuits Filed Against FDA to Block its E-Cigarette Deeming Regulations

Last month, I reported that Nicopure Labs, a maker of e-liquids and vaping devices, filed a lawsuit against the FDA challenging its deeming regulations, claiming that they are in violation of the Administrative Procedures Act (APA) and the First Amendment. Today, I report that four more lawsuits have been filed against the agency; all seek an injunction against enforcement of various aspects of the regulations or seek to overturn the regulations in their entirety.

1. Lost Art Liquids, LLC has filed a challenge to the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment. 

As the company explains: 

"Lost Art Liquids' Complaint alleges that FDA's regulation of vapor products is illegal in that it exceeds the very limited and specific scope of authority Congress granted FDA to regulate "tobacco products" under the Tobacco Control Act in 2009. "Vapor products are technology products, not tobacco products," said Ryan Thomas, Lost Art Liquids' Co-Founder and COO. "The legislative history and factual findings that serve as the predicate to the Tobacco Control Act make clear that Congress never intended to give FDA authority to regulate vapor products when it enacted the Tobacco Control Act in 2009. It was created to regulate products like cigarettes and smokeless tobacco, not vapor," he continued. "FDA has introduced one of the most burdensome, misguided and harmful regulations in its history without adequately sound science, or adhering to required, lawful procedures. These regulations will harm Lost Art Liquids' business and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars," added Thomas."

2. Larry Faircloth, a delegate in the West Virginia House of Representatives, has filed a lawsuit against the FDA, challenging the deeming regulations under the APA, the First Amendment, and the Tenth Amendment. 

First, the complaint alleges that FDA's application of the Tobacco Act to all vaping devices and their components goes far beyond the Act's definition of "tobacco products" and is therefore a violation of the APA. For example, "programmable software," "batteries," and "glasses and vials" are deemed to be tobacco products even though they clearly do not meet the Act's definition of a tobacco product (i.e., a product made of tobacco or containing a tobacco-derived component [nicotine]).

Second, the complaint alleges that the FDA's ban on new product introductions after August 8, 2016 is arbitrary and capricious and without a rational basis. The effect of this aspect of the regulation is to prevent the introduction of any new products and the improvement of any existing products, thus harming the public's health both by forcing many vapers to return to smoking and by precluding necessary safety improvements.

Third, the complaint alleges that the FDA failed to conduct a proper cost-benefit analysis, as it failed to quantify the benefits of the regulation and grossly underestimated the costs. For example, the agency estimated that only 750 pre-market tobacco applications would be required, while the truth is that there are single companies that would have to file that many applications alone.

Fourth, the complaint alleges that the regulations violate the First Amendment because they prohibit companies from making truthful and non-misleading statements about their products (such as that e-cigarettes contain no tobacco and produce no smoke or that they contain lower levels of various constituents compared to tobacco cigarettes).

3. A coalition of vaping-related 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.

Many of the complaints in this lawsuit are similar to those mentioned above, including the allegations that the FDA exceeded its authority, violated the intent of Congress, lacks a rational basis for the regulatory scheme (especially since it treats e-cigarettes more harshly than cigarettes), fails to conduct a proper cost-benefit analysis, and infringes 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. The suit challenges the grandfather date, the entire pre-market authorization process, the ban on allowing customers to try e-liquid flavors in vape shops that are restricted to adults, the application of the "tobacco product" definition to component parts of vaping devices that do not meet that definition, and the entire modified risk provision section.

4. Altria has filed a lawsuit which challenges the deeming regulations' prohibition on the use of the brand name "Black and Mild," which has been the trade name for one of its premium cigar brands for more than four decades.

This suit claims that the ban on the use of the term "mild" in the brand name violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents a taking of private property without compensation. Unlike the term "mild" as used in many cigarette brands and ads - which were documented to have been intended to falsely convey a sense of safety - the "Black and Mild" brand name has been around for more than 40 years and conveys information about the taste and body of the product, rather than its safety.

The Rest of the Story

All five of the lawsuits that have been filed so far present strong and solid legal challenges against the deeming regulations. I have been arguing for months that applying the modified risk provisions of the Tobacco Act to e-cigarettes would violate the First Amendment because there is no legitimate government interest in preventing commercial speech that is both truthful and non-misleading. In addition, I pointed out in my comments to OMB/OIRA that the FDA failed to conduct a proper cost-benefit analysis.

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