Tobacco Regulation on Steroids!! FDA Comes Down Hard on Tobacco Retailers
[Posted on: Thursday, November 05, 2015]

Since the passage of the Tobacco Control Act in 2009, FDA’s Office of Tobacco Products (OTP) has been aggressively asserting its authority over all kinds of tobacco products. In its short 5 year life, the OTP has issued more Warning Letters than both CDER and CBER combined. OTP issued 331 Warning Letters to 273 by CDER and a measly 26 by CBER. And these 331 Warning Letters only apply to tobacco product companies. It has been particularly strict with the retailers of tobacco products. It has conducted a whopping 508,000 inspections of retail outlets and issued 35,700 Warning Letters to retailers many of them small mom and pop stores. The number of inspections and Warning Letters is unprecedented, much more than any of the centers at FDA. There are about 500,000 tobacco retailers in the US, so it seem practically every tobacco outlet was inspected by the FDA. Now, the center has taken another new process and started issuing punitive damages to retailers it finds to be non-compliant. In May of this year, the OTP released a new draft guidance document describing the No Tobacco Sale Order (NTSO) which applies to retailers what were found to be non-compliant more than 5 times in 36 months. The guidance is still draft but it has already been implemented. This week 8 retail establishments were issued the first ever NTSOs. A review of the list shows that all these 8 are small retailers; gas stations, ethnic grocery stores, small pubs, and small liquor stores. The first NTSO requires suspension of all tobacco sales for 30 days, the second one for 6 months and the third time the retailer will be permanently banned from selling tobacco product. The next step is Civil Money Penalty which could hit hard on retailers already suffering from loss sales. The main reason these retailers were found to be non-compliant is because they did not check the ID of the person purchasing tobacco. No doubt that Congress wanted strict enforcement of tobacco sales to minors and, just like liquor sales, retail stores should verify the age of purchasers. Small stores many times are lax in checking IDs and are now learning the hard way. If the intent of these actions by FDA is to discourage the tobacco retail industry, it is sure to have the desired effect. Whether Congress wanted the same, is a debatable.