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July 31, 2008

Expanding the FDA's Duties

The FDA has struggled mightily in recent years to keep our food and drugs safe.  Maybe it's a good thing that tobacco is already unsafe...

Decades after the surgeon general first warned that cigarettes were a health hazard, the House of Representatives overwhelmingly approved legislation on Wednesday that would for the first time give the Food and Drug Administration the power to regulate tobacco products.

... 

The show of support in the House, which passed the bill by a vote of 326 to 102, illustrated not only the strength of antismoking sentiment in the country but the benefit of enlisting a powerful ally. The legislation was partly the result of negotiations with Philip Morris USA, the nation’s largest cigarette company, which split with other companies by endorsing it.

Only three Democrats voted against the bill--none from Oregon...and Walden voted for it too.  How would this bill benefit Philip Morris?  Most articles, including this one, didn't do much with that issue.

Most large public health groups supported the measure—and its passage was applauded by groups including the American Lung Association and the American Heart Association—but some antismoking advocates said the bargain struck with Philip Morris gave too many concessions to the industry.

The bill specifically states that the FDA’s new powers would stop short of the ability to order the elimination of nicotine from tobacco products or place an outright ban on all tobacco products.

But the agency could reduce nicotine to nonaddictive levels if it determined that doing so would benefit public health. The FDA could also require changes in tobacco products, like the reduction or elimination of other harmful ingredients.

The bill bans flavored cigarettes that appeal to young people but exempts menthol from that ban. The exemption raised objections from black antismoking advocates because mentholated cigarettes are frequently chosen by black smokers.

To satisfy the Congressional Black Caucus on that issue, last-minute changes were made in the bill to direct a scientific advisory committee to issue recommendations on menthol in cigarettes within one year.

Part of the reason Philip Morris dropped its objections to the bill was that menthol was exempted.  Sales of Marlboro Menthol are growing rapidly.  And switching links... 

Other tobacco companies complain that the bill would largely lock in Philip Morris's No. 1 spot. It would provide a "competitive advantage to our larger rivals," Lorillard said in a recent statement.

"It makes the development and marketing of safer tobacco products impossible while providing no guidance to the FDA as to how to carry out this new regulation," Lorillard's statement added.

Philip Morris doesn't see such a barrier. "The smokeless tobacco category holds great promise for PM USA in the coming years," executives told investors this year.

That's somewhat reminiscent of the tobacco settlement, which created a barrier to entry for producers not subject to the agreement. 

FYI, the original bill was introduced in both the House and Senate last year.  The Senate bill (625) was sponsored by Kennedy and has 56 cosponsors, including Wyden.  It faces a veto, though supporters are trying to make it veto-proof.  Returning to the original article...

The amendments also require the FDA to publish an action plan on the advertising and promotion of menthol and other cigarettes to young people, giving priority to minority communities.

...

The legislation would finance the FDA’s tobacco supervision primarily through new fees paid by tobacco companies that are earmarked for that purpose.

If the legislation is enacted, consumers would see a wholesale revamping of the warning labels on tobacco products. The small messages currently on cigarette packs warning of the negative health effects would be replaced by graphic images of the physical ravages often caused by cigarettes, such as lung tumors and mouth growths.

Canada has a bunch of graphic warnings on cigarette packs that show and explain what smoking can do (see them here).  But, my Canadian relatives who smoke never notice them. 

The bill will also require cigarette makers to provide detailed disclosure about the type and quantities of ingredients in their products — like ammonia and acetaldehyde — which are believed to work with nicotine to increase the addictiveness of cigarettes and smokeless tobacco. The requirements mean that companies would be required to disclose internal research on the biological effects of those additives.

Cigarette companies could no longer advertise their products as “light” or “ultralight” to convey the notion of less harmful ingredients. Some companies have anticipated those changes by packaging their products so that cigarettes packs are color-coded to denote different blends.

Under the bill, any outdoor advertising of cigarettes, and advertising in publications seen by children, would have to be in black and white, to reduce their visual allure.

I'm sure the new black and white ads will be some of the most effective ever produced.  

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Comments

Does that mean the ATF is now just the AF?

Best as I can tell from reading the bill, this is new work for the FDA without downsizing the old in the ATF. A number of Republicans who voted against the big claimed that their objections were over increasing the size of government.

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