FDA Regulation Threatens Cigarette Alternatives


This evening the House of Representatives is expected to approve a bill authored by Rep. Henry Waxman (D-Calif.) that would let the Food and Drug Administration regulate tobacco products. The bill, which is supported by Philip Morris but opposed by its smaller competitors, is also supported by the leading anti-smoking groups but opposed by some of their smaller competitors. Recently the dissenters in the anti-smoking movement have been highlighting one of the bill's major flaws: It would grandfather in all current cigarettes (except for those with politically incorrect flavors) while making it virtually impossible to introduce and promote safer alternatives.

One of those alternatives is snus, Swedish-style oral snuff, the health risks of which are negligible compared to those of cigarettes. The Waxman bill would not ban snus, but it would prohibit manufacturers from informing consumers about oral snuff's dramatic safety advantages. Another cigarette alternative, one that probably would be kept off the market altogether under the bill's regulatory standards, is electronic cigarettes, battery-powered devices that deliver odorless nicotine vapor instead of smoke, avoiding all the hazards associated with tobacco combustion products. Sen. Frank Lautenberg (D-N.J.) wants the FDA to take electronic cigarettes off the market "until they are proven safe." Even if the FDA does not ban e-cigarettes under its existing drug authority, their manufacturers probably would not be able to meet the test established by the Waxman bill for products that compete with cigarettes.

One anti-smoking group that supports snus, e-cigarettes, and other harm-reducing alternatives to standard cigarettes is the American Association of Public Health Physicians (AAPHP), which says (PDF):

A variety of non-pharmaceutical alternative nicotine delivery products are already on the market or in various stages of development and market testing. These include sticks, strips, orbs, lozenges and e-cigarettes. The information available suggests risk and benefit profiles similar to widely accepted pharmaceutical nicotine replacement products.

Holding the snus and alternative nicotine delivery to the research standards of pharmaceutical products would cost the manufacturers millions of dollars per product and would deny current smokers the benefits of these products for a decade or more. Furthermore, such studies probably could not be conducted at current American academic centers because Institutional Review Board (IRB) guidelines would likely prohibit case/control studies on products with no therapeutic benefit. Thus, the seemingly reasonable research standards in the Waxman bill would likely result in a de-facto ban on all such products. AAPHP therefore favors the research guidelines from the Buyer bill [alternative legislation introduced by Rep. Steve Buyer (R-Ind.)].

Since both the Waxman and the Buyer bills would approve currently marketed cigarettes, the most hazardous of all tobacco products, the standard for lower risk products for use by current smokers should be the hazard posed by cigarettes, not a pharmaceutical safety standard.

Bill Godshall of Smokefree Pennsylvania (who alerted me to the AAPHP statement), tobacco policy blogger Michael Siegel (who clued me in to the e-cigarette controversy), and the American Council on Science and Health also worry that FDA regulation could stifle the market for cigarette alternatives. I explain why the Waxman bill is bad for smokers herehere, and here. I discuss snus here, here, and here.