FDA Can Regulate E-Cigarettes as a "Modified Risk" Tobacco Product

By Joseph Fawbush, Esq. on December 13, 2019

A D.C. Circuit Court of Appeals panel recently held that e-cigarettes will have to undergo significant FDA scrutiny under the Tobacco Control Act's “modified risk" product standard, blowing away an industry group's First Amendment challenge like so much mango-flavored vapor.

“Indisputably Highly Addictive" and “Pos[ing] Health Risks"

It's hard to measure the damage vaping is doing to Americans. While the research is ongoing, we do know that nicotine itself is harmful, particularly for adolescents and young adults. In addition, the “vapor" in e-cigarettes is not water vapor: it is an aerosol that includes known carcinogens. For example, researchers have tested e-cigarettes as containing five to 15 times the formaldehyde of traditional cigarettes. And, of course, we still don't know the exact cause of the outbreak of a severe and deadly lung disease that has currently sent 2,409 e-cigarette users to the hospital, although THC e-liquids containing vitamin E acetate as a thickening agent are suspected to play a role.

It's hard to know, then, whether vaping poses a lesser or greater risk than traditional smoking. It's also hard to know what long-term lung damage is occurring through vaping. That is the background to a recent case before the D.C. Circuit Court of Appeals challenging the FDA's long-delayed regulation of e-cigarettes. The timing was not ideal for the challengers, to put it mildly.

As Circuit Judge Cornelia Pillard put it, "E-cigarettes are indisputably highly addictive and pose health risks, especially to youth, that are not well understood."

The FDA's Regulatory Authority Over Tobacco Products

Congress enacted the Tobacco Control Act to curb America's nicotine addiction in 2000. The TCA granted authority to the Food and Drug Administration to more stringently regulate tobacco products, with an emphasis on preventing adolescent smoking. While the Act specifically prohibited an outright ban, any new tobacco products were required to go through one of three pre-market review pathways:

  • Purely recreational tobacco products
  • Products marketed as “modified risk" alternatives to cigarettes
  • Smoking cessation products

Any product containing tobacco must establish that its harms do not exceed its benefits, with the standards increasing according to whether it is considered a safer alternative to traditional cigarettes. In 2014, the FDA issued a Deeming Rule proposing e-cigarettes are tobacco products under the TCA, subject to the above "modified risk" pathway.

The Challenge

An e-cigarette manufacturer and distributor challenged both the FDA's Deeming Rule and the TCA, arguing that:

  • The FDA violated the TCA by failing to provide an easier pathway for e-cigarettes to go to market
  • The FDA erred in using a “modified risk" standard that impermissibly burdens e-cigarette manufacturers and distributors from marketing truthful statements about vaping, such as “tar-free"
  • The TCA, which bans issuing free samples of tobacco products, violates the First Amendment

A Unanimously Unpersuaded Panel

The panel did not agree with the plaintiffs on any argument, writing that it “is entirely rational and nonarbitrary to apply to e-cigarettes the Act's baseline requirement." Congress made the requirement that all new tobacco products undertake pre-market review, not the FDA, so the FDA could not take into account whether e-cigarettes were less harmful than traditional tobacco and fast-track its approval even if it wanted to.

The panel also dismissed the First Amendment arguments, writing that how a product markets itself can be a determination as to which regulatory regime it is subject to. Moreover, the uncertain danger of vaping, coupled with Congress' substantial interest in promoting the public health, is more than enough to justify the FDA's classification of e-cigarettes as a “modified risk" tobacco product.

Finally, the panel found that issuing free samples is not expressive conduct under the First Amendment, and therefore can be prohibited.

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