Two More Lawsuits Filed Against the FDA

Has vaping found an unlikely ally?

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FDA Approved

Then there were four. Two cigar manufacturers have filed suit in federal court challenging the FDA’s deeming regulations, which also cover cigars, pipe tobacco and hookah tobacco. While vapers are justifiably concerned about the rule’s effect on the vapor industry, we may have just as much to gain from lawsuits brought by the real tobacco manufacturers.

The recent suits were brought by John Middleton Company LLC — which is owned by Altria —  maker of Black and Mild cigars, and Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC, makers of the 1502 cigar brand.

Previous lawsuits were filed by e-liquid manufacturers Nicopure Labs, LLC (owner of Halo E-Liquids) and Lost Art Liquids. The deeming rule goes into effect August 8, when the market is frozen. After that day, no new products may be introduced for sale unless they have undergone the expensive pre-market tobacco application (PMTA) process.

According to the CSP Daily News website, the Middleton suit challenges the FDA’s authority to prohibit use of the word “mild” to describe and brand their cigars, on First Amendment and other grounds. Among other claims, they allege that the FDA’s action restricts protected free speech. Middleton claims that the Tobacco Control Act only restricts use of the word “mild” when used to describe a “modified risk” product. 

Are tobacco companies our allies?

Cigar

The other suit may be more interesting. According to The Cigar Authority’s website, “Global Premium Cigars believes that the predicate date is a violation of substantive due process under the Fifth Amendment.” The predicate date — also known as the grandfather date — is the dividing line between products allowed to freely remain on the market and those that will be forced to submit to the expensive and burdensome PMTA process to earn approval for sale.

For example, a cigar that was being sold on February 15, 2007, will be able to be sold after the deeming rule’s grace period is over (August 8, 2018) with no further actions required of the seller. But a cigar (or vapor product) that entered the market on any day after that would have to prove that it is a benefit to the overall public health. How is that distinction fair or justifiable?

Global Premium Cigars also is alleging that the deeming rule  violates the Small Business Act.

This and the due process claim are grounds we haven’t seen so far in a vapor industry suit. There are more legal actions likely to come from the cigar industry too. While the cigar manufacturers’ suits may be of secondary interest to vapers, the fact is that relief from the crushing regulations might come from actions taken by any of the deemed tobacco products.

It can’t hurt us to be in the same boat as established industries like cigars and pipe tobacco. One might even hope to find a sympathetic ear in Washington among judges and legislators, many of whom indulge in a cigar now and then.

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Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.