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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