NATO Responds on FDA E-Cig Action Statement

NATO puts FDA statements about enforcement of e-cig age laws into perspective.

Following FDA Commissioner Scott Gottlieb’s statement titled “Forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan,” the National Association of Tobacco Outlets (NATO) gave its take on the Commissioner’s comments and what it means for the industry.

NATO’s statement is as follows:

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“The FDA Commissioner’s statement lists 15 retail chains that have accumulated an aggregate of 15% to 44% violation rates by their respective stores at which tobacco products were sold to underage individuals under the FDA retail inspection program since 2010.

“This statement needs to be put into perspective given that the FDA has been conducting retail store compliance checks for nine years now. According to the Commissioner’s statement, 15 store chains had sales to minors violations in 15% or more of ‘their total inspected stores since the inception of the FDA’s retailer compliance check inspection program in 2010.’ This means that a retailer which accumulated an aggregate 44% violation rate over the nine-year period could have, on average, experienced a 95% successful passing rate each year with approximately 5% of its stores inspected incurring a violation on an annual basis.

“According to the FDA’s method of determining aggregate violation rates, this estimated 5% violation rate would be added up for each of the nine consecutive years to obtain an approximate, but cumulative, 45% failure rate.

“Similarly, a retailer that has a 15% cumulative violation rate over that same nine-year period would have, on average, passed FDA compliance checks 98.3% of the time with an estimated yearly 1.67% failure rate. Calculating compliance inspection rates on a cumulative basis can result in an erroneous perception that a retailer sells tobacco products to underage youth numerous times each year. These compliance check percentage results should be analyzed on an annual basis and not added together because doing so results in an inaccurate characterization of the actual rate of violation.

FDA Plans ‘Policy Changes’
“Besides the focus in the FDA statement on these cumulative compliance rates, an important paragraph is the third paragraph from the bottom of the Commissioner’s statement.

“That paragraph reads as follows: ‘We’ll also be sharing additional planned policy changes and actions soon. I still believe that e-cigarettes present an important opportunity for currently addicted adult smokers to transition off combustible products and onto nicotine delivery products that may not have the same level of risks associated with them. But if these trends of youth e-cigarette use persist, we’ll be forced to consider regulatory steps that could constrain or even foreclose some of the opportunities for currently addicted adult smokers to have the same level of access to these products in order to protect youth.’

“In short, Commissioner Gottlieb is indicating that additional policy announcements will be issued soon regarding the sale of flavored electronic cigarettes. According to a news report issued by Axios, Commissioner Gottlieb met with White House officials last week to brief them on these upcoming FDA policy changes. When the agency makes a public announcement about these policy changes, NATO will report on the announcement.”