FDA Announces New Compliance Check Inspection Notice

If a minor succeeds in purchasing a regulated tobacco product during a compliance inspection, the FDA will now send the retailer a “Compliance Check Inspection Notice” after the inspection occurs.

Last week, during an FDA-hosted compliance training Webinar for retailers, the FDA announced it plans to use a new Compliance Check Inspection Notice if a minor is able to enter a retail store and purchase a regulated tobacco product, the National Association of Tobacco Outlets (NATO) reported. 

Currently, the FDA has contracted with 37 states and the District of Columbia to conduct retail compliance inspections.

The FDA conducts two kinds of retail inspections:

1.) A minor, under the supervision of a trained inspector, enters a retail store and attempts to purchase cigarettes, RYO cigarette tobacco, or a smokeless tobacco product.  For this type of inspection, the retailer is not informed prior to the inspection that an inspection will occur and the retailer may not be informed that an inspection occurred at the time the inspection takes place.

2.) An inspection that may or may not involve a minor and is conducted to determine whether a retail establishment is complying with all of the other FDA tobacco regulations.  In this type of inspection, a FDA inspector may announce himself or herself to the store manager at the time the inspection occurs, and the store personnel may be asked questions by the inspector.

If a minor succeeds in purchasing a regulated tobacco product during the compliance inspection, the FDA will now send the retailer a “Compliance Check Inspection Notice” after the inspection occurs.  The FDA will be sending these new notices out to inform a retailer that a potential violation occurred at their store due to the sale of a tobacco product to the minor and to inform the retailer of the date and approximate time that the inspection occurred. 

The notice will also indicate that the FDA’s Center for Tobacco Products will review the inspector’s report and determine whether the retailer violated the federal tobacco regulation prohibiting the sale of tobacco products to a minor.  If so, the FDA will follow up by sending either a warning letter to the retailer or a notice that the FDA is seeking a fine. The warning letter or fine notice will explain how a retailer may respond to such a warning letter or fine notice.

 

 

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