FDA Decision on Menthol Expected Soon

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FDA Decision on Menthol Expected Soon


LAS VEGAS -- Mitch Zeller has only been at his post at the Food and Drug Administration (FDA) for seven weeks, but there is hope his leadership as director of the Center for Tobacco Products (CTP) will jumpstart some stalled initiatives -- notably a possible menthol ban and substantial equivalence applications.

After attending a panel which included Zeller at the 2013 NATO Show in Las Vegas today, Wells Fargo Securities' managing director of tobacco, beverage and consumer research Bonnie Herzog said Zeller "indicated he was interested in establishing an open, honest and direct dialogue with the industry and further indicated he is looking forward to working with all constituents in fulfilling public health issues."

Zeller wants to implement common objectives that establish processes that are "fairer, clearer and more transparent," added Herzog.

Zeller began his post on March 4, taking over for Dr. Lawrence Deyton, who stepped down to become a clinical professor of medicine and health policy at the George Washington University School of Medicine and Health Sciences, as CSNews Online previously reported. He brought with him an extensive background of FDA-related experience.

During his first several weeks on the job, Zeller has concentrated exclusively on the menthol debate and substantial equivalence applications. According to Herzog, he indicated menthol is a critical issue for the agency and it is getting closer to make a move on the issue -- though he didn't provide specifics.

The menthol debate has been hanging over the tobacco industry for the past several years. In a draft report to the agency in March 2011, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) recommended removing menthol cigarettes from the marketplace. However, there has not been any movement on the issue since then.

"We view this as very positive since this has been an overhang, specifically for Lorillard Inc.," Herzog said. Lorillard products include the Newport menthol cigarette brand.

Greensboro, N.C.-based Lorillard has also been vocal about the delay in getting new products approved through the FDA's substantial equivalence process.

Industry insiders are also waiting for FDA direction concerning electronic cigarettes. Although the agency said in April 2011 it would regulate e-cigarettes like tobacco products, it has yet to issue any regulations.

It has been widely believed the agency's TPSAC would take up the issue at its meeting on April 30. However, according to Herzog, Zeller did not specifically address the products other than to note the agency is evaluating this very "interesting" category.

"We are cautiously optimistic that under Zeller's leadership, the industry is closer to getting some resolution on the critical outstanding issues," she said. "At the end of the day, uncertainty surrounding these issues has cast a shadow over the industry and reasonable and transparent regulation is the ultimate goal."