Thursday, September 15, 2016

Selling Tobacco to Kids: FDA Inspection Data from 2015 and 2016

A September 15 Food & Drug Administration press release (here) states that the agency “has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors.” 

The FDA compliance check program aims to assure that retailers – both brick-and-mortar and online – don’t sell tobacco products to children.  If a retailer is noncompliant, the FDA issues a warning letter; subsequent violations can result in a fine, and the “FDA may pursue a No-Tobacco-Sale Order (NTSO) against retailers that have a total of five or more repeated violations of certain restrictions within 36 months.” (here) 

Let’s take a look at the compliance results for the past two years.  Data is reported for fiscal years (October 1 to September 30), so the 2015 data is complete, while the 2016 data extends only to August 31 (available here).

So far this year, 89% of retailers have been compliant in 151,190 inspections.  Warning letters resulted from 9% (n = 13,124) of inspections, and fines have been levied to another 3,015 retailers (2%).  As the chart shows, these numbers are almost identical to those from 2015.

It is noteworthy that these results are substantially worse than five years ago, when the FDA was just starting its compliance program.  In 2011, data I examined from 16 states showed an overall compliance rate of 96% (here).  By now, the rate should have risen to near 100%; it is unacceptable that it has fallen to 89%.

By extrapolation, 9 out of 10 retailers in the U.S. do not sell tobacco products to kids.  As a society, we should not tolerate the fact that 10% of retailers put children at risk.  The percentage should be zero.

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