While retailers have long been accustomed to inspections checking on compliance with tobacco and nicotine product age restrictions, the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has announced a new emphasis on a second type of inspection … “Advertising and Labeling” inspections.” These are conducted in a very different manner than what retailers are used to and have caused some alarm and many questions from NACS members. “Are these legitimate?” “What are they looking for?” “Do I need to comply?” This article hopes to answer these and other questions.
While most of these restrictions are common knowledge to retailers, the area of particular concern is products lacking premarket authorization.
Who Is Doing These Inspections?
The FDA contracts with states, territories and Tribes to inspect retail establishments within their jurisdiction (when feasible). FDA-commissioned inspectors complete FDA training and conduct the inspections on behalf of the FDA. The inspector’s role is to gather information. Their observations are sent back to the FDA for review.
What Happens During an Inspection?
The inspections are unannounced. Upon entering the store, the inspector will introduce themselves by name, title and organization, and provide credentials. They will then ask to speak with the most responsible employee within the store and will present them with FDA Form 482—“Notice of Inspection.” The employee will then be asked to give:
• Their name
• The establishment’s name, physical address and phone number
• Ownership information
The inspector will then sign the Form FDA 482, present it to the employee and commence with the inspection.
What Are They Looking For?
According to FDA, “The inspector will observe the method and manner that the retail establishment is selling regulated tobacco products.” This includes:
• Not giving away free samples
• Not breaking open cigarette or smokeless tobacco packages to sell products in smaller amounts
• Not selling cigarettes, cigarette tobacco or roll-your-own tobacco that contains a characterizing flavor (except menthol or tobacco)
• Not selling products that lack the required premarket authorization
• Ensuring that required warning statements are on all tobacco products
The inspector will observe the method and manner that the retail establishment is selling regulated tobacco products.”
While most of these restrictions are common knowledge to retailers, the area of particular concern is products lacking premarket authorization. This is mainly focused on vaping products. For years, NACS has urged the FDA and CTP to produce a definitive list of what may and may not be legally sold. It appears that CTP is currently using “enforcement discretion” regarding the products currently under premarket review (and will not provide a list of those products), but they have not confirmed whether that will continue and there is currently great confusion within the marketplace as to which products are legal to sell. They have even gone so far as to refuse to answer questions from NACS about which products are subject to court challenges.
What Happens After the Inspection?
The inspector will not share any findings with the store. Rather, they will forward the inspection results to the FDA. Once the FDA has reviewed the inspection evidence, if violations are found, generally the FDA sends Advisory Actions (i.e. warning letters) the first time an inspection reveals a violation of federal tobacco laws and regulations.
Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to:
• Administrative actions (e.g., civil money penalties or no-tobacco-sale orders)
• Judicial actions (e.g. seizure, injunction or criminal prosecution)
• In its announcement of the heightened Advertising and Labeling inspections, the FDA concluded with: “We hope retailers will partner with the FDA to help protect their communities by knowing the law and making use of tools to prevent underage sales.” To that end, NACS encourages retailers to utilize resources at your disposal such as We Card (www.wecard.org) for training and up-to-date information about local, state and federal laws and TruAge (MyTruAge.org) for state-of-the-art age verification.