By TIM THORNBERRY
Kentucky Correspondent

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) isn’t wasting any time getting down to the business of regulating the tobacco industry, since landmark legislation gave the agency that authority last June.

On Aug. 19, the FDA launched its new Center for Tobacco Products, which is in charge of implementing the Family Smoking Prevention and Tobacco Control Act (FSPTCA). Lawrence Deyton, M.D. M.S.P.H. will serve as the Center’s first director.

According to information released by the FDA, Deyton is an expert on veterans’ health issues, public health, tobacco use and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences.

“I am eager for the challenge of leading the tobacco team at FDA,” said Deyton. “This is a tremendous opportunity for us at FDA to work hand-in-hand with the CDC (Centers for Disease Control and Prevention), researchers at the National Institutes of Health and public health leaders in the states to make progress in combating tobacco use – the leading cause of preventable death in the United States.”

A week later the agency officially established the Tobacco Products Scientific Advisory Committee (TPSAC) which will provide advice, information and recommendations to the commissioner on health and other issues relating to tobacco products. The committee will consist of 12 members, including experts from the medical field.
Three members will represent the industry, one tobacco manufacturing, one tobacco growers and another, the small business manufacturing industry. Those members have non-voting status on the committee. A request for nominations to that committee has been placed on the Federal Register. Those nominated by Oct. 13 will be given first consideration.

On Sept. 22, a ban on cigarettes with flavors characterizing fruit, candy or clove was announced. The move is designed to reduce the number of children who start to smoke, something at the core of the regulatory legislation.

“Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our nation’s public health.”

In a letter sent to parties in the tobacco industry, the FDA specifically states the ban comes as a result of the FSPTCA provision that reads,  “… a cigarette or any of its component parts (including the tobacco, filter or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”

The letter also stated that those found to be in violation of the ban could face “injunction actions, civil money penalties and/or criminal prosecution for violating the requirements of the Act (FFDCA, sections 301, 302, 303). FDA intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement.”

What is being banned

Just what products are included in the ban is as clear as mud to many. The specific language of the Act states “a cigarette or any of its component parts (including the tobacco, filter or paper).” But what about little cigars?

In a posted transcript of a question-and-answer session with media regarding the ban, FDA officials said other products such as small cigars and menthol products would be looked at in the future by the TPSAC with the “definition of cigarette” being important to what further action may take place.

According to the Federal Cigarette Labeling and Advertising Act, the term cigarette means, “any roll of tobacco wrapped in paper or in any substance not containing tobacco, and any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette.”

During one exchange of questions Deyton was asked, “If it’s wrapped in a tobacco leaf does that make it not covered in the ban?”

Deyton’s response was, “The – if it – according to the law, as (my reading the) law – and I’m not a lawyer – but if something is wrapped in a tobacco leaf, and is – would not be considered a – hold on just a second.”

At that time, Catherine Lorraine, an attorney at the FDA in the Office of Policy and Planning, stated, “I just want to draw your attention to the portion of the definition of a cigarette, which specifically refers to the appearance of the product and how it is perceived and offered for sale to consumers. And so we will be looking at products on an individual basis to determine if it meets that aspect of the definition of a cigarette.”

So, for now, the ban does not include small cigars. It also does not include “bona fide” pipe tobacco.

As to how the agency will enforce the ban, the FDA states it “has a range of enforcement and regulatory tools to address violations of the ban by, among others, manufacturers, importers, distributors and retailers. Before taking enforcement action, it is the agency’s general practice to issue Warning Letters to firms to notify them that they or their products are in violation of the law and to give them the opportunity to come into compliance.

“As always, when circumstances are appropriate, FDA may take enforcement action to protect the public health without first issuing a Warning Letter.”

The FDA is also asking the public to help by reporting by telephone, mail or through the agency’s website any violations they may encounter.

Published on Sept. 30, 2009