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FDA Announces Plan for Restricting Access to Flavored E-Cigarettes

FDA Commissioner Scott Gottlieb announced plans to “restrict” sales locations for flavored e-cigarettes that appeal to youth. The restriction, which falls far short of a ban, will require sales to take place only in “age-restricted in-person locations and, if sold online, under heightened practices for age verification.”

The restriction does not apply to menthol, mint, or tobacco flavors because, ostensibly, these appeal in greater percentages to adults. Even so, Gottlieb cites that 20% of kids, roughly 720,000, choose menthol flavoring for e-cigarettes and 54% of minors who smoke combustible cigarettes choose menthol as well. A full ban against similar flavorings, i.e., those that appeal to youth and young adults, was issued for tobacco cigarettes in 2009.

Gottlieb, who rolled back strict enforcement over the e-cigarette industry last year so as not to stifle innovation, is now concentrating FDA efforts on preventing youth e-cigarette use. In this press statement Gottlieb said, “Any policy accommodation to advance the innovations that could present an alternative to smoking – particularly as it relates to e-cigarettes – cannot, and will not, come at the expense of addicting a generation of children to nicotine through these same delivery vehicles.”

Gottlieb’s change of heart is in direct response to the 2018 National Youth Tobacco Survey (NYTS) report which shows that during his “wait-and-see” year, e-cigarette use in high schoolers jumped 78%, and middle schooler use jumped 48%. This one-year rise equates to an astonishing 1.5 million students.

To be clear, this notice was given to announce a “plan,” not to institute a rule. Gottlieb’s press release was carefully worded (perhaps to placate the vaping industry), and rather noncommittal.

For example, he stated, “My aim is to have…best practices available soon.” “Soon” will have to wait for a public input period—the same type of period that resulted in Gottlieb delaying FDA application requirements for vaping products (now 2022). Perhaps more disturbing, however, was Gottlieb’s rather naïve statement to e-cigarette companies:

“Responsible manufacturers certainly don’t need to wait for the FDA to finalize these policies to act. They can stop certain marketing and sales practices — the ones we believe are part of the youth access and youth appeal problem — right now.”

Over 50% of e-cigarette companies are owned by tobacco companies. These are the same companies that lied to the public for years, purposely increased nicotine levels in cigarettes to increase addiction and thus buyers, and targeted children in advertisements to ensure future smokers and long-term economic stability for tobacco companies.

To suggest these companies take voluntary measures “right now,” to decrease their share of a multi-billion dollar industry, and then expect them to do so in any substantial way, is absurd. If Gottlieb really wants to effectively protect minors from nicotine addiction and use, he needs to institute a flavor ban—”right now.” And institute and enforce last year’s proposed regulations—”right now.”

COPYRIGHT © 2019, STARK & STARK

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About this Author

Domenic B. Sanginiti, Jr, Stark Law, Personal Injury Lawyer, Civil Litigation Attorney
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Domenic B. Sanginiti, Jr. is an associate and member of the Accident & Personal Injury Group. He concentrates his practice in personal injuries arising from automobile, truck and motorcycle accidents, in addition to personal injuries claims resulting from slip and fall accidents and various other civil litigation matters.

Prior to joining Stark & Stark, Mr. Sanginiti, Jr. practiced personal injury for two South-Jersey law firms, where he defended casinos against personal injury claims, as well as defending health insurance carries against claims for benefits under ERISA.  He...

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