The prospect that FDA will acquire authority to regulate tobacco products is real. Two bills have already been introduced in the Senate --one by Senator Frist (R.-Tenn.) and the other by Senator Harkin (D. Iowa). Furthermore, the largest tobacco company, Phillip Morris, is openly supporting FDA authority to regulate its cigarettes. What gives and what's likely to happen?
The "what gives" question is relatively simple to answer. The effort of FDA to regulate tobacco, undertaken by former FDA Commissioner David Kessler, was ultimately derailed by a 5-4 decision of the U.S. Supreme Court. Nevertheless, the record established by FDA during several years of its investigation and development of a regulatory regime have altered the legislative and regulatory landscape for tobacco.
The proposition that tobacco should be regulated (and regulated by FDA) has become close to conventional wisdom. Ironically, FDA's effort to regulate tobacco, which began with a letter in response to a petition to it to assert jurisdiction, a letter that essentially called upon Congress to legislate, may yet result in legislative authority over tobacco.
The notion of FDA regulation of tobacco, which was once ferociously attacked by the tobacco companies, is no longer an anathema to some of them, notably Phillip Morris. Several reasons account for this change.
First, the tobacco companies crave legitimacy and a regulatory regime might help to provide it. Second, some of the tobacco companies have developed cigarettes that they believe are "safer" than those currently marketed. Bringing so-called safer cigarettes to market without regulatory approval would be foolish from a product liability standpoint and, depending on the claims for the product, might trigger FDA jurisdiction (that is, the claims for the product might be deemed to trigger "drug" jurisdiction).
Third, since regulation unavoidably increases the cost of doing business and raises barriers to new entrants into the market, some suspect that the Phillip Morris' support for FDA regulation of tobacco is best explained by its desire to solidify its market position.
Does this all mean that FDA regulation of tobacco is inevitable? No, but perhaps only because in Washington at least, conventional wisdom is no guarantor of the future. Most observers of Congress believe that if a bill to authorize FDA to regulate tobacco were to reach the floor of the Senate, it would pass with perhaps as many as 70 votes. The "if" is big, of course, and there is no assurance that a bill will get to the floor. It is also likely that a bill on the floor of the House would pass with a comfortable margin.
Finally, the prevailing view at the moment is that if a tobacco regulatory bill were to reach the desk of the President, he would sign it.
What are the implications of FDA jurisdiction over tobacco for food companies? Most notable are the resource implications. The resources available to FDA in the food area are already limited, and the lack of resources is causing concern within the regulated community that consumer confidence in the safety of the food supply is fragile and could be destroyed (as it has been in Europe) by a food safety crisis. Tobacco jurisdiction, if not accompanied by additional resources for FDA (whether appropriated or through user fees), could put extraordinary strain on food safety programs.
For example, if one assumes that tobacco jurisdiction would include a regime under which ingredients in tobacco products were regulated, it would be natural for the Office of Premarket Approval in the Center for Food Safety and Applied Nutrition to assume the responsibility for tobacco ingredient regulation. This Office has principal responsibility for the regulation of food ingredients and improving its performance through process changes and additional resources has been a priority for FDA and the food industry for the past five years.
The effort to improve the functioning of the Office of Premarket Approval has yielded considerable progress, all of which would be lost if the Office had to turn to the development and implementation of a tobacco ingredient program. Other aspects of tobacco regulation could also negatively impact the resources available to FDA for its traditional functions.
In the past, the FDA regulated community—food, pharmaceutical and medical device companies--have cautiously viewed FDA regulation of tobacco, based on the legitimate concern that their interests will suffer as FDA struggles to implement a new and challenging system.
As Congress considers tobacco legislation again this year, caution should once again prevail.