FDA drags heels on new tobacco products


The FDA has been delaying the approval of new tobacco products, says the AP. Image: SuperFantastic/Flickr/CC BY

According to the Associate Press, the Food and Drug Administration has been blocking the introduction of new tobacco products for more than 18 months. The tobacco industry says cigarettes have not changed, so the delay is meaningless. Meanwhile, watchdogs say that tobacco companies have been effectively skirting the review process.

New tobacco products in limbo

The tobacco industry typically introduces dozens of new products every year. However, the AP says that the FDA has been sitting on nearly 3,500 new tobacco product applications. Around 90 percent of those applications have been in limbo for over a year. The review process is supposed to last only 90 days.

The backlog began, says the AP, in 2009 when the FDA took over the regulation of tobacco products.

The FDA cites ‘deficiencies’ and caution

The FDA says those applications have backed up due to “significant deficiencies” and because it takes extra caution with products that can impact the public health adversely.

Big tobacco balks

Meanwhile, the tobacco industry says it is being unfairly targeted. Cigarettes are basically the same as they always were, it says, and many of the applications still to be reviewed are for such innocuous changes as packaging design, brand name changes and new filter options. Therefore, says big tobacco, the delay is unjustified.

Industry watchdogs cry foul

However, some industry watchdogs are saying that the tobacco industry is already selling most of those yet-to-be-reviewed products anyway by taking advantage of a grandfather clause that allows products to be sold while still under review.

One such product is Philip Morris USA’s Marlboro Black NXT. It has a capsule in the filter that can be crushed if the smoker wants to switch from regular to menthol mid-smoke break.

Matt Myers, president of the Campaign for Tobacco-Free Kids, said the loophole is wrong. Further, he added, the FDA should take a stand on the matter by acting “strongly and decisively to make public either why these product should be allowed to be marketed or to get them pulled off the market immediately.”

Another approximately 400 of those pending products have yet to reach the consumer, however.

Smoking, once the habit of most adults, has lost much its appeal over the years. In 1970 — six years after the Surgeon General’s report on the harmful effects of tobacco — only 40 percent of American adults smoked. In 2004, that had fallen by more than half to about 19 percent. That is about where it continues to hover today.

A legal substance

Still, tobacco is a legal substance and a legal industry that contributes to the economy. Is the FDA’s unprecedented reluctance to move forward with new tobacco products interfering with free trade, or is it a noble push to improve the health and lives of Americans?

What do you think?


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