FDA takes control of tobacco: Is it going to grow some teeth?

This week, the House of Representatives is considering a spending bill that would increase the Food and Drug Administration's (FDA) budget by 11 percent. At the same time, the embattled agency is beginning to take on a new role as the primary regulator of tobacco products.

Many legislators disagreed with the decision to place the FDA in charge of tobacco. The organization has, traditionally, regulated products that are beneficial if used properly; tobacco, on the other hand, is harmful or fatal if used as directed. Critics have argued that giving the FDA control of tobacco would, effectively, suggest that it can be consumed in a safe manner. However, according to Rep. Henry Waxman (D-Cal), the FDA's position as a "scientific organization with regulatory powers" puts it in an ideal position to handle the killer weed.

Over the past few years, the FDA has faced a problem with enforcement. Often accused of having no "teeth," the agency has not had enough funding to adequately police the nation's food, drugs, and medical equipment. Moreover, as the recent Zicam warnings demonstrate, even when the FDA can identify a potential threat, it can't enforce its will.

In the case of tobacco, however, the agency has been given an impressive spate of powers. It has the authority to require changes based on what it considers "appropriate for the protection of the public's health." This phrase, which seems almost deliberately vague, enables the agency to make rules affecting every aspect of the tobacco trade, from product development, to additives, to packaging and marketing. To begin with, the FDA can ban or limit additives that are designed to affect tobacco's flavor or potency, which means that menthol cigarettes, as well as ammonia or formaldehyde-laced brands, may well become a thing of the past.

The FDA also has the power to restrict marketing to the "fullest extent permissible," as long as it doesn't impinge upon the tobacco companies' first amendment rights. In all likelihood, this particular phrase will soon show up in a Supreme Court case. The FDA can ensure that advertising doesn't appear near schools or playgrounds, and can even control the packaging of cigarettes. Terms like "light" or "mild" are likely to be more heavily regulated, and graphic depictions of the ravages of smoking may begin to crop up on boxes.

The FDA will also have pre-market approval of new tobacco products. Since the agency will be focused on limiting the dangerous effects and addictive tendencies of smoking items, this will presumably translate into a refusal to vet products that aren't aimed at reducing smoking dependence and nicotine consumption.

In fact, it is probably easier to quantify what the FDA can't regulate. The agency cannot ban smoking outright, nor can it ban a particular type of tobacco product. It also cannot force companies to completely eliminate nicotine from their products. These rules, however, are pretty narrow and leave a lot of leeway for interpretation.

As the FDA eases into its new role, it remains to be seen if its expanded powers and increased funds will be the first step in a newly-energized regulatory agency.
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