US: FDA''s Zeller Promises Action on Product Applications

Source from:  Tobacco Journal International  05/17/2013

Tobacco regulators at the Food and Drug Administration are "very close" to releasing the first decisions on allowing new products under the agency's substantial equivalency (SE) model, said Center for Tobacco Products Director Mitch Zeller. 
 
Zeller, named CTP director in March, said the SE decision making process will gain momentum after the initial decisions, "until we catch up with the entire backlog of applications".

New tobacco products cannot be put on the market without FDA approval. The SE process allows manufacturers to avoid lengthy and expensive testing by gaining marketing permission through documentation showing the new tobacco product is identical to one already on the market, or is different but does not raise new public health issues.

A regulatory wrinkle allows products introduced after 15 Feb, 2007, but before 22 March, 2011, to be marketed provided an SE application was submitted by 22 March, 2011. If regulators ultimately reject that application, the product must be taken off the market.

CTP has made "substantial progress" on a long awaited deeming rule to expand the list of tobacco products regulated by the FDA to, for example, regulate electronic cigarettes. Regulators also are nearing a decision whether to ban mentholated tobacco products, Zeller said. "We are getting closer to announcing decisions on those issues", he said.

Zeller spoke to the annual meeting and conference of the Tobacco Merchants Association.

"Addressing the backlog of SE applications is a high priority of mine" Zeller said. "Interactions with manufacturers have helped us to better understand the information submitted ... decisions will start to be released, with more and more coming on a rolling basis going forward", Zeller said. Enditem