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Opposition in search of a rationale: the case for Food and Drug Administration regulation
  1. M L Myers
  1. Correspondence to:
 Matthew L Myers

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For more than a decade, public health leaders have called for government regulation of tobacco products. The consensus in support of government regulation recognised that, absent strong new governmental authority, the tobacco industry would continue to do the following: pursue marketing practices that are deceptive, have a negative impact on children and discourage quitting; withhold information vital to public health scientists; secretly manipulate their products in ways that make them more dangerous and more addictive; market products that the public perceives to be less hazardous while having no incentive to market products that, in fact, deliver fewer toxins; and undermine prevention efforts by using unsubstantiated claims, such as “light” or “low tar”, to keep people smoking.

To address these concerns, in May 2004 long time public health champions Senators Edward Kennedy and Mike DeWine and Congressman Henry Waxman introduced in the US Congress legislation granting the US Food and Drug Administration (FDA) sweeping regulatory authority over both new and existing tobacco products and their marketing. This legislation is consistent with or stronger than the regulatory principles established by a consensus of American public health groups as well as the recommendations of the Institute of Medicine of the National Academy of Sciences, the World Health Organization’s Scientific Advisory Committee on Tobacco Product Regulation, and the WHO Framework Convention on Tobacco Control.


The legislation was endorsed by former FDA Commissioner David Kessler, former Surgeon General C Everett Koop, 60 national organisations including the American Cancer Society, the American Lung Association, the American Medical Association, the American Public Health Association, and more than 400 affiliates of those organisations and other local public health groups. Conservatives in Congress, every tobacco company except Philip Morris, tobacco retailers, and tobacco advertisers, vigorously opposed the legislation.

Among its provisions, the legislation:

  • Curtails many specific marketing practices that impact youth. In addition, it gives the FDA authority to further restrict tobacco marketing to the maximum extent permitted by the First Amendment to the US Constitution,1 the broadest authority Congress can give FDA.

  • Requires tobacco companies to disclose what is in each tobacco product by quantity in each brand and sub-brand, including all ingredients, constituents, and smoke constituents, and to promptly inform the FDA of any changes to the product2 providing FDA with unprecedented product information.

  • Grants the FDA unprecedented authority to set toxicant exposure standards for and require changes in both current and future products to “protect the public health”. The FDA may require the reduction or removal of any harmful ingredients or naturally occurring constituents, including smoke constituents. The FDA can also reduce nicotine to minuscule levels that do not lead to addiction. The FDA can take these steps without first having met the nearly impossible burden that such a proposed action will reduce the risk of disease.3 The FDA can also prohibit manufacturers from publicising that they meet new standards in order to prevent manufacturers from misleading consumers into believing that these products are safe or safer. This is the most sweeping authority any regulatory agency has ever possessed to require changes in tobacco products.

  • Bans certain flavourings that make tobacco products more appealing to non-smokers and gives the FDA authority to ban still others.

  • Prohibits the terms “light”, “mild” or “low” and significantly improves the health warnings on tobacco products and their ads.4

  • Prohibits reduced risk claims until the FDA first determines both that the product: (1) as actually used will significantly reduce the risk of disease to individual consumers; and (2) as marketed will benefit the population as a whole taking into account its impact on initiation, quitting, and relapse.

  • Prevents tobacco companies from using reduced exposure claims to circumvent the law by holding that a reduced exposure claim is a health claim. Strict standards are set for such exposure claims. They are permitted only so long as the best available science is inadequate to meet the more rigorous standard for a specific health claim and even then are permitted only when: (1) the best available science demonstrates that a measurable and substantial reduction in risk is anticipated; and (2) the manufacturer can prove that consumers will not be misled into believing that the product has been proven less hazardous.

  • Gives the FDA the authority to set rules for how so called reduced risk products will be marketed, and requires post-market surveillance of their actual usage.5 This will encourage manufacturers to produce products that actually reduce the risk of disease by only permitting claims that can be proven and will eliminate the unproven claims now being used to mislead smokers.


Perhaps one reason for opposition is that there are misconceptions about the legislation. Contrary to the interpretation of some critics it does not focus on just new products or misleading claims. It gives the FDA broad authority over both current and new products to “to protect the public health”. The FDA is authorised to do what is necessary to reduce the number of people who die from tobacco use.

Other criticisms are also misplaced. Adoption of regulatory authority over the tobacco industry will not create the impression that the tobacco problem is resolved. Proponents of regulation recognise that regulation is not a panacea, but an additional tool. Regulation will also not add to the legitimacy of tobacco products that already arises from the government’s current acceptance of these products, but it can rein in tobacco company behaviour.*

Once Philip Morris endorsed the legislation, opposition arose from a number of individuals who had not opposed previous bills that were either similar or contained weaker authority to require changes in existing products or to regulate so called reduced risk products.

Underlying the opposition is a fundamental issue—a belief that any legislation endorsed by Philip Morris cannot be good for public health. Philip Morris broke with the rest of the industry when it supported this Bill. It accepted proposals the public health community had long sought and the company had opposed. Philip Morris’ support is cause for careful scrutiny but not a reason for rejection. Philip Morris has supported the Framework Convention for Tobacco Control and legislation to curb internet sales of tobacco and smuggling, yet these initiatives deserve support. This may be one case where what one company decides is in its interest may be bad for the industry as a whole and, therefore, good for public health.

Somehow, the critics of this legislation argue that giving the government authority to curtail tobacco marketing, expand youth access restrictions, modify current and existing tobacco products, improve health warnings, eliminate unsubstantiated and misleading health claims, and require tobacco industry disclosures is bad for public health. The alternative to government regulation is not the elimination of tobacco; it is the status quo. This Bill addresses longstanding problems and does so in ways that have long been endorsed by public health experts.

This Bill would provide the most comprehensive regulatory approach ever adopted. The one thing we know for certain: without this kind of legislation the tobacco industry will continue to manipulate its products without our knowledge and devise its marketing in ways that are designed to keep people smoking without regard to the harm that cigarettes cause.



  • * Some critics have expressed concern that this legislation will eliminate the litigation threat to tobacco companies. Section 917(b) states specifically that the Bill does not modify the liability of a tobacco company. More importantly, if the legislation resulted in less wrongdoing by tobacco companies and, therefore, gave consumers less of a reason to sue them while saving lives, the net impact would be positive.