Monday, March 21, 2005

Campaign for Tobacco-Free Kids Releases List of What FDA Tobacco Legislation Would Do

The Campaign for Tobacco-Free Kids today released a list of what it claims the Philip Morris-supported FDA tobacco legislation would do. According to the Campaign, the legislation would:
  • Reinstate the 1996 FDA rule on youth access to tobacco and tobacco marketing;
  • Give FDA the broadest possible authority to further restrict tobacco marketing;
  • Require detailed disclosure of product content;
  • Give FDA broad authority to require changes in tobacco products;
  • Strictly regulate explicit and implicit health claims;
  • Ban terms like "light," "mild," and "low";
  • Require larger health warnings
  • Expand state and local authority to regulate tobacco advertising
The Rest of the Story

Here is my account of what the FDA tobacco legislation would do, revealing the absurdity of this legislation from a public health perspective:
  • It bans the presence of strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee in cigarettes, but does not inherently disallow the presence of hydrogen cyanide, carbon monoxide, N-nitrosodimethylamine, benzene, radioactive polonium 210, or nitrogen dioxide.
  • It requires FDA to ban any tobacco product that contains a severely harmful chemical defect, but explicitly prevents FDA from doing the same with tobacco products that contain thousands of severely harmful chemicals, so long as those chemicals are ordinarily contained in tobacco products.
  • It provides for stringent regulation to prevent adulterated or misbranded products, but leaves the "pure" and "properly branded" deadly products largely unregulated.
  • It requires that manufacturers report any adverse health effects of its products that are unexpected, but the expected 400,000 or so deaths per year due to these products require no special attention.
  • It expresses grave concern for the tremendous harm to the public health caused by tobacco products that falsely purport to reduce disease risk, but does not require that FDA do anything about the high-dose products.
  • It strictly regulates new tobacco products introduced to the market for safety and health, but allows existing products to continue killing hundreds of thousands of Americans each year (there is no requirement that FDA do anything to regulate existing products).
  • It allows FDA to reduce or eliminate specific smoke constituents, but no one knows which constituents and in what combination and amounts are responsible for disease, nor does anyone know whether reducing or eliminating some of these constituents would have any effect whatsoever on health.
  • It expresses grave concern over youth access to tobacco products and calls for comprehensive restrictions on the sale of tobacco products to minors, but it explicitly prevents FDA from regulating the sale of cigarettes in any specific retail establishments (including malls, grocery stores, restaurants, gas stations, convenience stores, bowling alleys, and even pharmacies).
  • It provides for extremely rigorous and comprehensive (and probably impossible) tobacco company reporting of brand-specific levels of tobacco smoke constituents, but does not require any particular action concerning the many constituents that are already known to be harmful.
  • It requires the FDA to prescribe labeling requirements for the proper use of the tobacco product. How does one properly inhale dangerous chemicals and deadly carcinogens?
  • It requires FDA to consider periodically new medical data on cigarette risks, but the existing evidence on the established risks of cigarettes can be largely ignored.
  • It requires notification to all tobacco product users of the substantial health risks of any new tobacco products, but no special notification procedures for the existing deadly products.
  • It requires FDA to recall and ban any tobacco product that contains a manufacturing defect that is not ordinarily present in tobacco products, but a serious defect - such as producing death - is fine, so long as the deaths are caused by an ordinary constituent of the product rather than a new manufacturing defect.
  • It allows the FDA to prescribe strict regulations to protect the public's health from sub-standard packing and storage, but the fact that what is being packed and stored is inherently dangerous is of little concern. The FDA may prescribe stringent regulations to eliminate any pesticide residues on the tobacco, but the rest of the toxins inside the tobacco are not necessarily regulated.
  • It essentially ensures that true reduced risk products never enter the market, and that existing high-risk products never leave it.
  • It explicitly gives Congress the authority to immediately review and overturn any FDA-promulgated regulations that it does not like.

The Campaign for Tobacco-Free Kids' concluded that: "The language is carefully crafted to curtail abuse and to ensure the FDA has the broad authority over tobacco products it needs to protect public health and save lives."

I think a more accurate conclusion regarding the legislation would be: "The language is carefully crafted to limit FDA's authority in order to protect Philip Morris and its profits."

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