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LAS VEGAS -- The Food and Drug Administration (FDA) began looking to take control over tobacco products in the 1990s, but it took an act of Congress in 2009 to give the agency what it wanted. Now, from the perspective of at least one former FDA insider, the agency is controlling tobacco through the retail industry.
"When I look at where things stand, my greatest concern is the issue of retailers," said Seth A. Mailhot, special counsel for the Food and Drug Law Group at Sheppard Mullin Richter & Hampton LLP, who delivered the Tobacco Plus Expo 2012 keynote address this morning. "If the FDA is going to get to us, it is through the retail chains. They are the easiest pathway."
Mailhot, who worked at the FDA for 14 years, pointed to the number of warning letters issued to retailers since the agency began retailer inspections in September 2010. According to his numbers, the FDA has issued more than 1,350 warning letters to tobacco manufacturers and retailers since 2009. The retailer warning letters hit a peak -- to date -- in September 2011 when 300 letters were sent out.
"This is an incredible amount of warning letters," he said, noting that the letters are just the first step in the chain that then leads to civil penalties.
Of the retailer warning letters that have been issued, 224 were sent out to Mississippi retailers, 180 to Missouri retailers and 168 to Colorado retailers -- just to name a few of the top states.
"[The number] is off the chart for the agency," Mailhot explained. "It has never issued this many warning letters for a single product in a single year."
Mailhot further noted a discrepancy with the FDA and its warning letters. Retailers, he said, could be cited for selling tobacco products to a minor and for failing to check identification. However, according to Mailhot, some retailers are being cited for selling to a minor, but not for failing to check identification. Specifically, 1,036 warning letters were issued for selling to a minor, but only 688 warning letters were issued for failing to check identification.
"There is a lack of consistency by the agency on how they are enforcing the laws," he said.
As for the civil penalties that have been levied, Mailhot said the majority are in the $500 range for three violations, although three retailers were hit with "a whopping $5,000" for five violations, he said, adding that five violations is the minimum number of violations required for the FDA to issue a no tobacco sale directive. These numbers, he pointed out, come from only the five states that have compiled their civil penalty complaints.
"If the FDA has shown anything, it is that they feel the best way to control tobacco is at the retailer level," Mailhot said. "They are taking aggressive action and the numbers are startling."