FDA Increases Tobacco Compliance Checks

NACS  Online

Despite a sharp increase in the number of “no” violations among retailers selling alcohol, the violation rate among the total retailer universe drops from 2011.


 ARLINGTON, VA – The FDA’s Center for Tobacco Compliance (CTP) has updated its compliance check enforcement activity of retailers selling tobacco, which reveals a sharp increase in the number of compliance checks.

An analysis of CTP data by the We Card Program, which uses publicly available data at fda.gov, the 2012 totals and rates (through August 31) are as follows:

  • Total compliance checks: 67,096. This is up sharply from 2010 and 2011, when the totals were 507 and 35,462, respectively.
  • Number of “no” violations: 63,873. This is a significant rise from 2010 and 2011, when the totals were 483 and 33,720, respectively.
  • Number of warning letters: 2,845 (compared to 24 in 2010 and 1,734 in 2011).
  • Number of civil money penalties: 378 (compared to none in 2010 and 8 in 2011), with the average penalty $646.74.

Despite the sharp rise in the number of violations, the violation rate this year (4.80%) is down from 2011 (4.91%) and below the three-year average (4.84%).

Of the 37 states and Washington, D.C., that have FDA enforcement contracts, 36 states show enforcement activity, with Hawaii and New Mexico the lone states with contracts that do not show any compliance check data yet.

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