Tobacco

FDA Announces New Compliance Check Inspection Notice

Last week, the FDA hosted a compliance training webinar for retailers and announced the use of a new Compliance Check Inspection Notice if a minor was able to enter a retail store and purchase a regulated tobacco product. Currently, the FDA has contracted with 37 states and the District of Columbia to conduct retail compliance inspections (see accompanying map).

The FDA conducts two kinds of retail inspections. One type of inspection involves the use of a minor under the supervision of a trained inspector who enters a retail store and attempts to purchase cigarettes, roll-your-own (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.

The second kind of inspection 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 is able to purchase a regulated tobacco product during the compliance inspection, the FDA will now send to 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.

A copy of the FDA's webinar presentation conducted last week on this new compliance inspection notice accompanies this article.

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