Public Health Groups Express United Opposition to Davis FDA Bill
Letter to Congress States Bill 'Would Do More to Protect the Tobacco Industry than to Protect the Public Health'
June 26, 2001
Washington, DC — Contacts: Rachel Tyree, ACS, (202) 661-5707; Eric Webb, AHA, (202) 785-7931; Paul Billings, ALA (202) 785-3355; Michael Berman, CFTFK, (202) 296-5469
The American Cancer Society, the American Heart Association, the American Lung Association, and the Campaign For Tobacco-Free Kids have written to every Member of Congress to express their strong and united opposition to H.R. 2180. The legislation, recently introduced by Representative Tom Davis (R-VA), purportedly provides the U.S. Food and Drug Administration (FDA) with authority over tobacco products. But, public health groups argued the bill was written on behalf of tobacco giant Philip Morris and would not protect the public health due to numerous loopholes that would only benefit the tobacco industry.
In their letter, the groups wrote, 'in short, this bill, if enacted, would do more harm than good to the public health. That is why every major public health organization in the country opposes this bill. It is also why this bill does not even represent a starting point for further negotiations.'
The legislation is full of loopholes that are designed to tie the hands of the FDA and prevent the agency from taking steps that are in the best interest of public health. The public health groups' letter identified several areas where H.R. 2180 falls short:
Does not protect kids from tobacco industry marketing and advertising
Does not allow FDA to prevent use of terms such as 'light' and 'low tar' to describe tobacco products, even if making such claims is harmful to public health
Does not allow the FDA to require industry-wide modifications to tobacco products to protect the public health as it does for other products
Establishes the deadly risks posed by today's products as the standard against which future products are judged which limits the FDA's authority to approve new product or withdraw approval based on public health considerations.
The public health community supports strong, bipartisan legislation introduced in both the House and the Senate that would put an end to special treatment the tobacco industry currently enjoys. Rather, tobacco products would be held to the same regulatory standards already applied to all other legal and less harmful consumer products. The FDA would also be empowered to restrict sales and marketing to youth while forcing the tobacco industry to disclose ingredients in tobacco products.
Sample Joint Letter
June 21, 2001
Dear Representative:
We are writing to express our strong opposition to H.R. 2180, 'The National Youth Smoking Reduction Act,' legislation recently introduced by Rep. Tom Davis (R-VA) regarding U.S. Food and Drug Administration (FDA) authority over tobacco products.
Despite its title, this bill does little to protect the public health. It fails to protect our children from the most effective tobacco marketing tactics or significantly reduce our children's exposure to tobacco marketing. In addition, the bill includes loopholes that will prevent the FDA from requiring tobacco companies to reduce the harm their products cause even when the technology already exists to do so. In short, this bill, if enacted, would do more harm than good to the public health. That is why every major public health organization in the country opposes this bill. It is also why this bill does not even represent a starting point for further negotiations.
The Davis FDA bill has many major flaws. In many critical sections, the bill changes the standard under which FDA normally operates from one that places concern for public health as the top priority to one that protects tobacco industry interests. Virtually every important section has a loophole or a standard that would prevent FDA from protecting public health. Examples include the following:
FDA legislation should protect our children from tobacco industry marketing and advertising, but the basic standard in the Davis bill regarding youth access and marketing would make it difficult for the FDA to act. Under the Davis bill, the FDA, in order to restrict a specific type of advertising, would have to prove in court a direct causal link between the advertising and the use of tobacco products by children 17 years old and younger. Given that the tobacco industry continues to deny that any of its advertising is targeted to children, the standard in the Davis bill will result in endless litigation and delay. Moreover, most of the advertising restrictions in the Davis bill are already contained in the settlement agreement between the tobacco companies and the states and have not resulted in any significant decreases in tobacco industry marketing to children.
The standard in the Davis bill regarding advertising would not give the FDA the flexibility to prohibit the type of advertising that results in the public being misled about the relative safety of tobacco products. A recent Institute of Medicine study found that claims made in the 1960's boasting the increased safety of cigarettes due to lower levels of tar are unproven even today. Under the Davis bill, the FDA is not given the authority necessary to prevent claims such as 'light,' 'low tar,' or 'less risk of cancer' even if these claims are known to be misleading and result in fewer people quitting.
FDA should be authorized to create performance standards to require industry-wide modifications to tobacco products to protect the public health as it does for other products. For example, if research demonstrated that a specific type of filter reduced exposure to one or more carcinogens in a way that reduced the harm caused by the product, a performance standard could be issued which would require each manufacturer to meet new standards regarding filter technology. The Davis bill includes criteria tied to 'consumer acceptability' that sounds benign but will result in endless litigation every time a tobacco company opposes a standard. For example, a small reduction of tobacco consumption, whether related to the standard or not, could be the basis for an industry claim that a new performance standard has left the product unacceptable to adults.
FDA legislation regarding tobacco should allow the agency to approve a new tobacco product or withdraw approval based on public health considerations. The Davis bill does establish an approval process, but limits the new requirements to ensuring that new products 'pose no greater risk to the public health than currently marketed tobacco products.' The Davis bill establishes the deadly risks posed by today's products as the standard against which new entrants to the market and future products are judged. Tobacco technology could be significantly different in five years. FDA decisions about new products should not hinge on a comparison to products that are currently on the market – today's products kill over 400,000 Americans each year.
For these and other reasons, the public health community is united in its opposition to the tobacco legislation introduced by Rep. Davis. We believe it would prevent the FDA from effectively regulating tobacco products.
Not only is the Davis FDA bill bad for public health, it is further confirmation of the close ties between the tobacco industry and Congress. There are now two proposals for FDA regulation of tobacco products, H.R. 2180 and S. 190, that have been opposed by every major public health organization and supported behind the scenes by Philip Morris. These proposals would do more to protect the tobacco industry than to protect the public health.
We urge you to reject the Davis bill. Unregulated tobacco products remain the single greatest cause of preventable death and disease in the nation. Every day more than 1,100 Americans are killed by tobacco, and more than 3,000 children become regular smokers. Bipartisan legislation, H.R. 1097 and H.R. 1043, that would provide FDA with effective authority over tobacco has been introduced by Representatives Ganske, Dingell and Waxman. We strongly encourage you to support these bills.
Sincerely,
Matthew L. Myers
President, Campaign for Tobacco Free Kids
M. Cass Wheeler
CEO, American Heart Association
John R. Seffrin
CEO, American Cancer Society
John R. Garrison
CEO, American Lung Association