RELEASE OF THE FDA'S CIGARETTE REGULATIONS, NOW IMMINENT, RAISES A HOST OF LEGAL, POLITICAL, SOCIAL AND OTHER ISSUES [08/08]

The imminent release of new regulations by the FDA, classifying nicotine as an addictive drug, and limiting the sale, promotion, and advertising of cigarettes to children, raises many novel issues, says ASH, the antismoking organization the tobacco industry principally blames for these rules.

The anticipated regulations are based upon a new legal principle established in a case known as ASH v. HARRIS. Also, in an unsuccessful law suit designed to stop the FDA from issuing the rules, the major tobacco companies charge that ASH's "threats," "pressure," and "a carefully orchestrated public relations campaign" were behind the FDA's proposed regulations.

AN INJUNCTION

A crucial issue is whether cigarette makers can prevent the rules from going into effect while they litigate their legality, says law professor John Banzhaf, Executive Director of Action on Smoking and Health (ASH).

To achieve this the burden is on them to show that they: (1) are likely to prevail on the legal issues, (2) will suffer irreparable injury if the rules go into effect, and (3) that their injury outweighs the injuries to the public health the FDA rules are designed to prevent.

Banzhaf says the industry is unlikely to win on the legal issues because of the overwhelming evidence þ leaked and other industry documents, sworn testimony of insiders, patent applications, etc. þ that the manufacturers regarded nicotine as an addictive drug, as well as the great weight courts are required to give to the findings of agencies in their area of the expertise.

It will also be hard for them to show that they will lose sales from restrictions on advertising, because the industry has always maintained that their ads are designed only to shift customers from one brand to another, and have no effect on overall consumption.

Any decline in sales from taking tobacco products out of vending machines, or requiring purchasers to prove their age with photo IDs, will be from sales to kids þ about which the tobacco industry can hardly complain and seek legal protection, argues Banzhaf. Moreover, since at least two cigarette makers offered to abide by many of the FDA's proposed rules, it's now hard for the industry to argue that they are too onerous or too far reaching, he says.

As to the third legal requirement for a stay, Banzhaf says that there is no dispute that over 3,000 kids become hooked on nicotine every day, and that there has been a dramatic 30% increase in teen smoking over only the last two years þ factors the court must balance against small losses in industry profits.

IMPACT

Although the industry claims to be most concerned by the long-term prospect that FDA regulation of nicotine in cigarettes (nicotine in gum, patches, and other formulations has always been regulated as a drug) might lead to the need for prescriptions for purchases, limits on nicotine content, etc., Banzhaf says that is unlikely, and that their real concerns are much more immediate.

He notes that most of the major law suits against the cigarette manufacturers þ including those brought by states, cities and counties, as class actions, and as individual suits by smokers and their families þ are based in part on the argument that nicotine is addictive.

Regulation by the FDA of nicotine as an addictive drug, and of cigarettes as drug delivery devices, could have a major psychological effect in persuading jurors þ including the ones now hearing the case of GRADY CARTER V. BROWN & WILLIAMSON in Florida (being broadcast on Court TV) þ that smoking is an addiction, rather than simply a habit like chewing gum.

FDA action may also trigger other regulatory actions.

Massachusetts, for example, has just passed a statute requiring the disclosure of all cigarette ingredients þ a requirement usually imposed upon drugs. Other jurisdictions could well follow.

Health insurance companies which now routinely provide coverage for treatment of addiction to heroin, cocaine, and alcohol could easily find that coverage extended to nicotine by state regulatory authorities, or in private law suits brought by individual insured or health organizations.

But perhaps the most profound impact of the FDA's decision, says Banzhaf, is that nonsmokers as well as smokers may begin seeing the problem of smoking as one of a chemical, physiological, or pharmacological dependance upon a drug as addictive for many people as cocaine þ and not simply as a habit and a lack of will power.

Measures appropriate to this new understanding are sure to come, he predicts, whether from the FDA, the courts, or elsewhere.

The effect could be as profound as the realization, from the EPA's report several years ago, that even minute amounts of secondhand tobacco smoke can cause cancer in nonsmokers, and that there is no need for airlines or businesses generally to provide places where smokers can puff away.

The result has been a massive move towards banning smoking in public places, rather than just restricting it to so- called "no-smoking" sections.

ASH - ACTION ON SMOKING AND HEALTH 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310