FDA to regulate tobacco

The bill will give the agency authority to oversee the advertising, marketing and manufacturing of tobacco products.

By Chris Silva — Posted June 22, 2009

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Physician organizations and public health advocates cheered the congressional passage of legislation that will place unprecedented new federal regulations on the tobacco industry. They said the move has the potential to prevent children from becoming smokers and reduce the number of deaths associated with tobacco use.

While the measure does not give the Food and Drug Administration the authority to ban outright the sale of cigarettes, cigars, smokeless tobacco and other tobacco products, it does allow the agency to reduce nicotine levels, administer product safety tests and issue recalls if necessary. A new office within the FDA, the Center for Tobacco Products, will implement the statute's regulations.

The House first passed tobacco regulation on April 2 by a 298-112 vote, and the Senate approved similar legislation by a 79-17 vote on June 11. The next day, the House approved the Senate version and cleared the way for President Obama's signature.

Obama used the opportunity in his June 15 address to the American Medical Association House of Delegates at its Annual Meeting in Chicago to praise the AMA for pushing the legislation, and said he will sign the bill.

Approval of the Family Smoking Prevention and Tobacco Control Act has long been sought by numerous public health advocates, including the AMA. The measure has been before Congress for about a decade, after the U.S. Supreme Court in 2000 struck down an FDA rule asserting the authority to regulate tobacco.

An estimated 400,000 Americans die each year from tobacco use, according to the Centers for Disease Control and Prevention, and approximately 1,000 children become new, regular smokers every day. Supporters hope the new regulation of the industry will help lower those numbers.

"Passage of this legislation represents an important break from the past, as it signifies broad acceptance that nicotine is a drug harmful to people's health," said outgoing AMA President Nancy H. Nielsen, MD, PhD.

The American Public Health Assn. called the measure a historic achievement. "After decades of allowing tobacco companies to market their deadly products to our children and deceive consumers about the harm their products cause, our nation has finally chosen to place public health above profit," said Georges C. Benjamin, MD, the association's executive director.

Menthol not banned

In addition to banning certain tobacco advertising that opponents said is directed toward children, the bill gives the FDA the authority to ban candy flavoring in cigarettes.

According to the American Cancer Society Cancer Action Network, the tobacco industry spends nearly $40 million every day to market its products, particularly to children, often by promoting "enticing candy- and fruit-flavored cigarettes."

"This bill has the power to finally break the dangerous chain of addiction for millions of Americans and save them from a lifetime of dependence, disease and premature death that comes with tobacco use," said John R. Seffrin, PhD, the Cancer Action Network's CEO.

But the statute does not allow the FDA to prohibit menthol flavoring without an official study. The National African American Tobacco Prevention Network withdrew its support for the bill because of the lack of a menthol ban. Underlying the need for such a ban is the fact that nearly 80% of African-American smokers use mentholated cigarettes, the organization said.

"Menthol, which masks the harshness of emissions and allows a bypassing of the body's normal defense mechanisms for preventing exposure to detrimental substances, has also been indicated by some research to increase the retention of cancer-causing substances," said William S. Robinson, the network's executive director. "African-American menthol smokers use fewer cigarettes per day but suffer disproportionately from their effects when compared to Caucasian smokers."

FDA ready to move

The new FDA chief said the agency welcomes the authority granted by the bill.

As it does with foods, drugs and medical products, the agency "will rely on the best available science in fulfilling its regulatory responsibilities concerning tobacco," said FDA Commissioner Margaret A. Hamburg, MD. "Because smoking and chewing tobacco cause serious public health problems, we view our new responsibilities as a logical extension of our public health mission to protect and to advance the health of Americans."

Some lawmakers opposed the legislation, saying the agency is already stretched too thin to take on the added responsibility of tobacco regulation. Others questioned the propriety of having an agency dedicated to public health overseeing a product that can never be safe when used as directed.

While some major tobacco companies opposed the bill, the nation's largest cigarette maker, Philip Morris, backed it.

"This legislation would establish a regulatory structure and standards for the manufacturing and marketing of tobacco products that should provide important benefits to adult consumers for many years to come," said David Sylvia, spokesperson for Altria Group, the parent company of Philip Morris. "We have supported tough but reasonable federal regulation of tobacco products by the FDA, and we are glad to see the progress Congress has made toward that goal."

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What the law does

The Family Smoking Prevention and Tobacco Control Act gives the Food and Drug Administration the authority to:

  • Reduce nicotine yields or other harmful components and conduct product testing.
  • Prohibit tobacco manufacturers, importers, distributors or retailers from advertising cigarettes within the U.S. without specified labeling.
  • Forbid the use of misleading terms such as "light," "low-tar" and "mild" and require larger, more specific health warnings.
  • Ban flavoring in cigarettes, including strawberry, grape, orange, clove, cinnamon and vanilla.
  • Prohibit all outdoor tobacco advertising within 1,000 feet of schools and playgrounds, and ban tobacco-brand sponsorships of sports and entertainment events.
  • Establish an application process for premarket approval of any new tobacco product, and require certain health information be included.

Source: Bill text (link)

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