On September 5, 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. These states include Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.
The FDA trains inspectors in each of these states to conduct compliance checks on behalf of the FDA’s Center for Tobacco Products. These inspectors are from existing state agencies that already regulate some facet of tobacco products or are involved in tobacco-related health issues. As of August 1, these FDA inspectors have conducted 91,477 retail store inspections and 95.4 percent of these retail stores have successfully passed the compliance inspections.
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, 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 new notice will also include a list of the federal tobacco regulations that a retailer needs to comply with as well as a picture of the store where 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 retailer that receives this new notice is not required to contact the FDA upon receipt of the notification. Rather, as stated in the notice, the FDA will contact the retailer again if the agency determines that a violation of the federal tobacco regulations occurred. However, if the retailer believes that the notice contains an error regarding the location or address of their establishment, the retailer should contact the FDA using the contact information on the form.