Retailer Update on FDA Enforcement Inspections

FDA Enforcement Inspections
FDA Inspections will use an underage person to monitor:

1)  Mandatory ID under 27 all tobacco purchases.

2)  Not selling to underage person (under 18).

3)  Flavored and individual cigarettes not being sold.

4)  No self-service displays.

FDA Fine Schedule

w/ Training Program    Violation  w/o Training Program

Letter                             1st                          $250

$250                    2nd in 12 mos.            $500

$500                     3rd in 24 mos.           $1000

$2000                   4th in 24 mos.           $2000

$5000                   5th in 36 mos.          $5000

$10000             6th or Subsequent      $10000

Violation within a 48-month


FDA Website of Stores Inspected 
FDA will not immediately notify a retailer if a store has passed an inspection.
For failed inspections, FDA will send overnight a Warning Letter to the store citing the violations.  Copies of Warning Letters will be published on the FDA website each week.
FDA Warning Letters will note the date, approximate time and product sold in the transaction. FDA Warning Letters require a response within 15 business days.
FDA will list the names and addresses of stores that were inspected and passed on their website.  The list will be updated monthly.
Copies of Civil Money Penalty Letters (CMPs) are now on the website.
Retailers will be able to view the website to determine if their stores have been inspected and passed.
States w/ FDA Enforcement Agreements
As of April 24, 2012:  (39 Contracts)

Alabama  Arizona  Arkansas  California  Colorado  Connecticut  Delaware  Georgia  Hawaii  Idaho  Illinois  Indiana  Iowa  Kansas  Kentucky  Louisiana  Maine  Maryland  Massachusetts  Michigan  Minnesota  Mississippi  Missouri    New Hampshire  New Jersey  New Mexico  North Carolina  Ohio  Oklahoma  Pennsylvania  RhodeIsland  Tennessee  Texas  Utah  Virginia  Washington  Washington DC  West Virginia  Wisconsin

*underlined states reporting on FDA site

FDA expects to award enforcement contracts to all states by EOY 2012.

Retailer Training Programs
FDA has reaffirmed its position on Tobacco Retailer Training Programs.
At some point, FDA will announce “specific regulatory requirements of elements to be in a Tobacco Retailer Training Program”.  No time table has been set for creating the regulations.
The Draft Guidance(s) in circulation offer FDA’s most current thinking on the elements that should be part of a Tobacco Retailer Training Program.
FDA Sting Failures
If an employee sells cigarettes to a 17-year old without asking for ID:

2 Violations have occurred

1) Did not ID under 27  Violation #1

2) selling to a person under 18  Violation #2

Failing 1st inspection (sting), FDA will issue Warning Letter with no fines.  Retailer response required in 15 business days.

The store will automatically be re-inspected by FDA. No time frame or notice given for re-inspection (sting).
If the store fails the next inspection (sting), then fines (CMPs) will be assessed.
Dollar fine (CMP) amounts determined by number of Violations per store.
Civil Money Penalty (CMP)–Fines
Fines (CMPs) are now being issued to retailers that fail a follow-up FDA inspection (sting).
Fine amounts based on number of Violations, using lower fee schedule for now.
Retailers will receive a CMP Cover Letter and Complaint outlining the Violations and fines.
Upon receiving the letter, the retailer has 30 days to reply, called an “Answer”.  The retailer has 5 options:

–pay the fine

-request a hearing

–request a settlement conference

–request extension to pay

–do not reply, cannot contest anything

Each reply option is outlined further in the CMP Complaint.  Do not ignore the CMP Cover Letter and Complaint, these are important documents!

For more information or questions please post comment on blog.



#1 SNUS GUY on 05.31.12 at 10:53 PM

Thanks for sharing this info.
Pretty serous fines listed!

#2 nanoo on 08.30.17 at 6:39 AM

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