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April 6th, 2008:

Empower The FDA To Regulate Tobacco

Michael Schwalbe – The News and Observer

RALEIGH – Invent a drug to help people stop smoking and you’ll need approval from the U.S. Food and Drug Administration before you can bring it to market. The approval process requires clinical testing, disclosure of ingredients and expert review of the data concerning safety and effectiveness.

All drugs that can have powerful effects on the body are similarly regulated. The curious exception is nicotine delivered in tobacco products. Fortunately, this deadly loophole might soon be closed.

That nicotine is a powerful drug is not in doubt. The 1988 Surgeon General’s report reviewed the scientific research on nicotine and concluded that it is as addictive as cocaine or heroin. Tobacco companies hated to see the word “addiction” applied to tobacco, but they were not surprised by the findings.

As we know from whistleblowers and from documents pried loose by litigation, the tobacco companies have long understood that they sell a psychoactive drug. In public they call tobacco use a habit. In private the companies acknowledge their dependence on nicotine’s addictiveness to stay in business.

Worse, the companies have manipulated nicotine levels to foster addiction. This was Judge Gladys Kessler’s conclusion in 2006 at the end of the five-year Department of Justice trial that found the industry guilty of racketeering and of lying about the health hazards of smoking.

Last year, researchers at the Harvard School of Public Health found that nicotine yields from smoking had increased each year between 1998 and 2005, by a total of about 11 percent. This was true for all brands tested.

Critics of the industry surmised that nicotine levels were adjusted upward to keep smokers addicted after the 1998 Master Settlement Agreement led to price increases that prompted more people to try quitting.

Legislation pending in Congress may soon curtail the industry’s ability to hook new users. The Family Smoking Prevention and Tobacco Control Act would give the FDA power to regulate tobacco products much as it now regulates other potentially hazardous consumables.

UNDER THIS LEGISLATION, THE FDA could require that nicotine levels in tobacco products be reduced to levels that do not cause addiction.

The legislation would also tighten controls on tobacco advertising seen by children. In addition, it would ban candy flavorings, require disclosure of ingredients to the FDA, forbid the industry from implying that “low-tar,” “light” or “mild” cigarettes are safer and require enlarged health warnings on tobacco products.

This legislation isn’t perfect. It won’t allow the FDA to reduce nicotine levels to zero. It doesn’t require disclosing ingredients directly to consumers. And it permits menthol flavoring.

Some critics of the legislation have argued that it might encourage tobacco use by allowing the industry to claim that its products are FDA approved. But after recent hearings by the House Energy and Commerce Subcommittee, language is being added to the bill to prohibit the industry from making such claims.

DESPITE ITS FLAWS this legislation could save millions of lives. So who could be opposed? Tobacco companies, naturally. But in this case there is a twist to the story.

The largest cigarette maker in the U.S., Philip Morris, supports the bill, while R.J. Reynolds and the smaller tobacco companies oppose it.

Philip Morris’ support reflects its beliefs that regulation would not threaten its dominant share of the market and that regulation would put a heavier burden on its competitors. Philip Morris also uses menthol flavoring not banned by the legislation, while R.J. Reynolds uses the kid-catching candy flavorings the legislation forbids.

Both of North Carolina’s senators, Richard Burr and Elizabeth Dole, recipients of a combined $132,700 in contributions from Reynolds over the last five years ($21,500 for Dole, $111,200 for Burr), oppose the bill. In doing so, they may serve the interests of one segment of the tobacco industry, but they fail to represent the views of most North Carolinians.

National polls show that two-thirds of Americans favor FDA regulation of tobacco. A 2007 survey by the Mellman Group found that 62 percent of adults in North Carolina’s 1st Congressional District felt the same way. That’s in tobacco country.

Every year in North Carolina about 14,000 teenagers start smoking and about 12,000 adults die prematurely because of smoking. As a result, we pay $2.46 billion in excess health care costs and $3.3 billion in costs due to lost productivity. Giving the FDA authority to regulate tobacco would help reduce these costs.

Some of North Carolina’s elected leaders agree (U.S. Rep. David Price co-sponsored the bill). Others are still in thrall to corporate interests that put profits ahead of public health. Urging our representatives in Congress to support FDA regulation of tobacco products is a way to tell them that it’s time for change, even in tobacco country.

(Michael Schwalbe is a professor of sociology at N.C. State University. He is writing a book about people whose lives have been changed by tobacco-related disease.)