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FDA's Zeller Talks Stop-Sale Orders, Inspections


LAS VEGAS — The process of regulating tobacco continues as the Food and Drug Administration (FDA) takes action on not substantially equivalent products, starts retail inspections on Native American reservations, and continues to work toward a final deeming rule.

Mitch Zeller, director of the Center for Tobacco Products at the FDA, explained that from a public health perspective, the world is fighting an uphill battle against disease and death caused by tobacco. The United States is still about "preventing the preventable."

His comments came during the "Vapor, Smoke and Mirrors: Making Sense of FDA Tobacco Regulations" educational session at the 2015 NACS Show Sunday.

Under its authority to regulate tobacco products, the FDA issued stop-sale orders against four R.J. Reynolds Tobacco Co. products on Sept. 15. The agency found Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were not substantially equivalent (NSE) to their respective "predicate" products as identified by the manufacturer. Predicate products were commercially marketed as of Feb. 15, 2007.

As a result of the review, the products can no longer be sold, distributed, imported or marketed in interstate commerce. According to Zeller, the products were "immediately illegal to sell."

The agency recognized that some of the products were already in distribution before the ruling, so the FDA exercised a 30-day period of enforcement that gave retailers 30 days to get those products already in their inventory off the shelves before the agency takes action.

This guidance, Zeller noted, "only applies to retailers and only to product in inventory before the order was issued."

The 30-day period expires later this week, at which point the agency will start in-store inspections and take appropriate action.

Thomas Briant, executive director of the National Association of Tobacco Outlets, explained there are more than 200,000 retail outlets in all channels selling tobacco and asked Zeller if the agency would consider another extension. However, Zeller responded that there will not be another extension.

"There was massive publicity around this. The guidance is the guidance and it's not going to change," he said, adding the agency will deal with any violations "on an individual basis once inspections take place."

On the topic of inspections, Zeller announced the FDA recently signed contracts with two tribal nations to begin retail checks of outlets on tribal lands and inspections have started with one of them. The process of retail inspections on Native American reservations "has been slower than anticipated," he acknowledged. 


The big question in the room, of course, was when the agency will issue its final deeming rule, giving it authority over electronic cigarettes, cigars, pipe tobacco and certain dissolvable products that are not smokeless tobacco.

The FDA released its proposed deeming regulation in April 2014, but has yet to take final action. The agency has continued to be mum on when that will happen. 

"There is a reason we don't talk publicly about things that have not been decided yet," Zeller said Sunday. "The process is deliberative and we cannot talk publicly about non-decisions."

He did add that a deeming rule is "a foundational step" that puts unregulated products within regulatory reach of the FDA and the agency cannot regulate them until that step is taken.

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