FDA seeking comments on draft guidance.
This week, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products issued a guidance document titled “Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with an Order,” the National Association of Tobacco Outlets (NATO) reported.
Under the Family Smoking Prevention and Tobacco Control Act (the federal law that granted the FDA the authority to regulate tobacco products), the FDA was authorized to conduct retail compliance inspections and impose fines for violations culminating in a “no-tobacco-sales” order for repeated violations of the federal tobacco regulations. A no-tobacco-sales order is an order issued by the FDA to a specific retail location prohibiting the sale of tobacco products for a specified period of time or an indefinite period of time, NATO explained.
According to the draft guidance, FDA is proposing to seek the following time periods for issuing no-tobacco-sale orders:
First No-Tobacco-Sales Order: 30 day prohibition on selling tobacco products
Second No-Tobacco Sales Order: 6 month prohibition on selling tobacco products
Third or More No-Tobacco-Sales Orders: Permanent prohibition on selling tobacco products
Before a retailer is faced with a no-tobacco-sales order situation, the FDA uses the following fine schedule for violations of federal tobacco regulations:
First violation, no fine, but a warning letter to the retailer
Second violation within a 12-month period, $250
Third violation within a 24-month period, $500
Fourth violation within a 24-month period, $2,000
Fifth violation within a 36-month period, $5,000
Sixth violation within a 48-month period, $11,000
FDA intends to seek the maximum time period for a no-tobacco sales order after a sixth violation, but the guidance notes the FDA may reduce the time period that tobacco sales are prohibited by taking into consideration the nature, circumstances, extent and gravity of prior violations and, with respect to the specific retailer, the effect an order would have on the ability of the retailer to continue to do business, any history of similar violations, and the degree of culpability on the part of the retailer.
FDA will also consider whether a retailer has taken effective steps to prevent the sale of tobacco products to underage youth including adopting and enforcing a written policy against sales to minors, informing its employees of all applicable laws, establishing disciplinary sanctions for employee non-compliance, and requiring employees to verify legal age through photo identification or electronic scanning device.
The FDA is allowing a 45-day period for interested parties to submit comments to the draft guidance document. NATO is reviewing the draft guidance and will determine if comments should be filed.
