Friday, May 22, 2009

Senate Committee Approves FDA Tobacco Bill; Aims to Put FDA in the Position of Approving Cigarettes for Sale and Consumption

Late Wednesday night, the Senate HELP (Health, Education, Labor & Pensions) Committee sent forward to the full Senate a bill (already passed by the House) which would put the Food and Drug Administration (FDA) in the awkward position of having to approve cigarettes for sale and consumption in the United States. The FDA, whose existing mission is to approve drugs and drug delivery devices for sale on the basis of their safety, would be in the position of having to approve a deadly product which kills about 400,000 Americans each year.

An article in the Louisville Courier-Journal quoted Wyoming Senator Michael Enzi, the ranking Republican on the committee, as arguing that the “FDA approves cures, not poisons.” The committee vote was largely upon party lines, with 12 of 13 Democrats voting for the bill and 7 of 10 Republicans voting against it.

The bill has recently come under criticism for its inconsistency in banning clove flavoring from cigarettes but not menthol. Clove cigarettes make up less than one-tenth of one percent of cigarettes sold in the United States, while menthol cigarettes account for 28% of domestic sales. Indonesia may initiate a trade complaint against the United States. According to a Bloomberg news article: "The case will depend on 'whether there is anything about cloves that allows you to say this is a health and safety issue.' ... A trade complaint by Indonesia would hinge on whether the U.S. can prove to the WTO that it’s banning clove cigarettes for health reasons and not to protect domestic producers."

The Rest of the Story

This legislation is imprudent, as it would completely undermine the FDA's mission by asking it to approve a deadly product for sale and consumption in the U.S. This foolishness is apparently an acknowledged concern of Senate bill supporters, who are worried that approval of cigarettes by the FDA might cause consumers to get a false sense of security about the safety of the product. Thus, the Senators on the HELP Committee who sent the legislation forward amended it to prevent the tobacco companies from communicating the truth to consumers: that the legislation puts the FDA in the position of approving cigarettes for sale in the United States.

As I have argued earlier, this is likely an unconstitutional provision, as truthful speech is strongly protected under the First Amendment. The cigarette companies will likely challenge this provision and I believe there is a good chance it will be overturned.

But beyond the legal implications, how good can the bill be if its supporters have to add a clause prohibiting the truth about the bill from being communicated to the American people?

While a trade complaint by Indonesia would not likely be successful, the concern about discrimination in the legislation does point to an astute argument against the bill: it does preferentially and inconsistently protect U.S. cigarettes. While menthol and clove are both cigarette additives, the bill is discriminatory by banning the flavoring which is hardly used at all in U.S.-made cigarettes and exempting the flavoring that is common in domestic cigarettes.

By aproving cigarettes, the federal government will join the tobacco companies in being culpable in the deaths of thousands of Americans annually from cigarettes. This is hardly a reasonable position for a federal agency whose charge is to protect the health and safety of the American public.

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