FDA Issues Guidance on Retail No-Tobacco-Sales Order

MINNEAPOLIS -- 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.”

 

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. 

 

Prior to the issuance of the new guidance document this week, the FDA had not determined the length of time that a retailer would be prohibited from selling all tobacco products if the same retail location had repeated violations of federal tobacco regulations, such as not requesting identification of a customer that appears to be under the age of 27 or selling tobacco products to a minor. The guidance document explains the FDA’s current thinking with respect to imposing a no-tobacco-sales order and includes the factors that the FDA will consider in determining the length of time an order will be in effect.

 

In the guidance document, the FDA is proposing to seek the following time periods for issuing no-tobacco-sale orders:

 

First No-Tobacco-Sales Order: 30 days

Second No-Tobacco Sales Order: 6 months

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

 

While the guidance document states that the FDA intends to seek the maximum time period for a no-tobacco sales order after a sixth violation, 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.  

 

In addition, in determining whether to reduce the no-tobacco-sale order time period, the FDA will 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.

 

Click here for a copy of the full draft guidance document issued by the FDA.