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Food and Drug Administration to Regulate Tobacco?


In 1995, David Kessler, former head of the Food and Drug Administration tried to regulate nicotine. His efforts failed when the regulations were struck down in the federal court system. Then, in 2004, the United States Senate passed proposed legislation to do so, only to have the House of Representatives fail to take up the issue. Now, Congress has again decided to evaluate whether the Food and Drug Administration should be charged with regulating tobacco marketing and the contents of tobacco products. If enacted, Congress would empower the FDA to regulate the contents of tobacco products sold in the United States.

Despite the fact that the bill has multiple goals which would greatly benefit the health of millions of Americans, President Bush and a parade of Senators voiced their strong opposition to this proposal, indicating, among other reasons, that the FDA is overburdened and that tobacco should not be a regulated product at all, because regulation would be equated in many people’s minds to “safe.” In a statement shortly after the vote, a White House spokeswoman, Emily A. Lawrimore, said the administration thought that the legislation would do more harm than good, creating a false impression that regulated tobacco products were safe. “The administration believes that tobacco is not a drug or device to be regulated by the F.D.A.”

If the FDA is empowered by Congress to regulate tobacco products, the bill would require, among other things: stronger label warnings, disclosure of the contents of all tobacco products and establish a timeline for manufacturers to remove and/or reduce harmful ingredients. Not disputing the fact that the extensive regulation would increase the FDA’s workload and require large sums of money, Representative Henry Waxman, a Democrat from California and the bill’s sponsor, says, “It simply means that when we give the agency this additional responsibility, we also must give it the resources necessary to handle the job and to handle it well.” To fund the new responsibilities, the legislation calls for each manufacturer to pay fees based upon that company’s market share.

The bill long supported by dozens of health advocates and anti-tobacco groups, the American Cancer Society and the American Academy of Pediatrics, has even gained the support of the largest maker of cigarettes in the country, Philip Morris (although many feel that this support is a marketing maneuver in and of itself to help drive smaller tobacco companies out of business). RJ Reynolds, who does not support the legislation, began a marketing campaign of its own, stating that the FDA cannot have the regulation of tobacco products added to their current responsibilities because the agency is already overburdened. While it is true that the FDA shoulders huge responsibilities to the American public, a more meaningful discussion should be focused on whether the FDA is the proper agency to regulate the product and appears disingenuous, at best, coming from a major manufacturer of tobacco products.

What healthcare and anti-tobacco advocates would really like is an outright ban on the sale of tobacco products, both in this country and worldwide. Astonishingly, the idea of regulating such a product does not appeal to many in Congress and to most manufacturers of cigarettes. Representative John Dingell, a Democrat from Michigan, and the Commerce Committee chairman, acknowledged that the legislation was not ideal. “In a perfect world, we’d ban all cigarettes,” he said. “But the hard fact of the matter is that there are a lot of jobs depending on this. And more importantly, there are a lot of people out there who are addicted to this, and they’ve got to have their fix.” Translation: MONEY is more important than the HEALTH of our citizens, which is a shockingly shallow interpretation of what is best for American citizens.

Yesterday, while kids all over the United States were celebrating National Kick Butts Day, William Corr, the Executive Director of the Campaign for Tobacco-Free Kids, said, “It is unacceptable that tobacco products are the number one cause of preventable death in the United States, yet they are virtually unregulated to protect our kids and the nation’s health. By granting the FDA authority over tobacco products, Congress can stop the tobacco industry from targeting our children and misleading the public. We hope Kick Butts Day will inspire our nation’s leaders to take effective action to protect children and save lives.”

Seems to me that with more than 400,000 people in the United States dying every year from a tobacco-related illness combined with the fact that cigarettes and other tobacco products are sold with only one goal in mind – to addict their users, thus increasing sales and profit margins – and with only one outcome for every user of the product – sickness and/or death – should be enough impetus for every branch of the government to want to regulate such a product.

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