Basic HTML Version
74
TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
TMA Highlights
The FDA and Retail Enforcement
“The centerpiece of FDA enforcement has been on the
retail side,” Seth Mailhot, special counsel at Sheppard
Mullin and a former FDA employee, told TMA
Conference attendees. “Retailers are on the front lines of
this issue.”
Recapping FDA activity at the retail level, Mailhot
noted that thus far the FDA has not assessed multiple
violations per location. “As of late 2011, the FDA had
conducted 60,000 inspections,” he said. “They were
rapidly approaching a point where the department had
done more inspections than all the other FDA centers
combined.”
Sale to a minor and failure to check identification were by
far the most common violations cited in the inspections, said
Mailhot, who noted that the FDA also seems to be targeting
the issue of self-service vending machines. “[Those] make up
20 percent of all violations listed.”
While the agency is federal, enforcement actions
and penalty assessment practices vary widely by state,
noted Mailhot, who pointed out that civil monetary
complaints are of greatest
concern because “these
have an actual effect
on retailers beyond
receiving a
letter.”
Penalties have ranged
from $250 to $5,000,
with different retailers in
the same situations often
receiving different fines. “You
can take two different complaints
that present the same facts and have one retailer
get a $250 fine and the other $5,000,” says Mailhot.
For example, in cases where a vending machine was
present, some retailers receive a fine for possession of
the machine while others receive a fine for possession
of the machine, failure to remove the machine and sale
to a minor, counting each as a separate violation and
rendering a $5,000 fine. For a look at observations
cited and fines assessed, see the table below.
TOB
Number of Violations
(Excluding Warning Letter)
Number of CMP
Complaints
CMP Amount
1
31
$250
2
61
$500
3
2
$2,000
4
5
$5,000
Violation
Explanation
Number of CMO
Complaints
Percent
1149.14(a)
Sale to a minor
85
85.9%
1140(b)(1)
Failure to check ID 57
57.6%
1140.14(e)
Failure to remove 16
16.2%
1140.16(c)(1) Self-service display 12
12.1%
1140.14(c)
Vending machine
8
8.1%
1140.34(b)
Free gift
1
1.0%
Most Common Enforcement Issues:
Civil Money Penalty Complaints