![[ASH Logo]](/images/ash3.gif) | ASH -
ACTION ON SMOKING AND HEALTH 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |
President Clinton's scheduled Friday announcement declaring nicotine to be an addictive drug opens the door to regulation of cigarettes by the FDA, and helps protect the proposed rules designed to limit the sale, advertising, and promotion of cigarettes to children.
In addition, such a presidential declaration could impact smoker suits against the tobacco industry, help force health insurance carriers to pay for withdrawal programs from nicotine as they now often do for illegal drugs and alcohol, and affect both congressional and presidential elections in November.
The long-anticipated announcement, says ASH þ the antismoking organization the tobacco industry principally blames for these rules, and the group whose law suit established the legal principle upon which the FDA is relying þ is a major victory in the war on smoking.
The Food and Drug Administration -- which has jurisdiction over foods, drugs, and cosmetics -- can regulate cigarettes only if it is determined that nicotine meets the statutory definition of a "drug."
Thus a presidential determination that nicotine is a "drug" opens the door for the FDA to adopt rules similar to those it proposed a year ago, all designed to help reduce the number of teen smokers.
In the past, the FDA has exercised jurisdiction over nicotine when it was found in nicotine patches, nicotine gum, and in so-called "smokeless cigarettes" which provided nicotine to the user without lighting up.
However, since the agency hasn't previously asserted jurisdiction over nicotine when it was found in tobacco cigarettes, a determination by the President the nicotine is a drug, in addition to the determination made by the FDA itself, will also help to protect the FDA's rules in the all-but-certain court challenge by the tobacco industry.
Although courts are required by law to give great deference to agency decisions þ especially those like the FDA's which involve scientific and medical expertise þ they are required to give even more deference to presidential determinations.
Thus, while such a presidential determination isn't legally required before the FDA can regulate nicotine, Clinton's move will make it much more difficult for the tobacco industry to challenge the finding in court.
The president's announcement could also affect hundreds of suits against the tobacco industry already in the courts, including one in Indiana slated to go to the jury tomorrow, and those filed by some thirteen states and a growing number of cities and counties.
The underlying theory of the Yvonne Roger's suit þ which involves a lawyer who began smoking at the age of 5, and became addicted before he entered his teens þ as well as most of the individual, class action, state and city law suits, is that nicotine is an addictive drug.
An announcement to that effect by the president of the United States, as well as by the agency charged with regulating drugs, would certainly lend a great deal of credibility to such arguments by plaintiffs' attorneys.
An official federal classification of nicotine as an addictive drug could also lead to calls þ as well as law suits þ seeking to require health insurance companies to provide coverage for nicotine withdrawal clinics.
Many policies already provide coverage for withdrawal from other addictive drugs (including alcohol), so that it can be argued that they have a moral and possibly even a legal obligation to provide similar coverage to a newly-determined addictive drug.
Needless to say, the President's decision is also likely to have significant political repercussions. Bob Dole's public statements about nicotine, and particularly his widely-discussed interview with Katie Couric, have already proven to be an embarrassment to the Republican presidential candidate.
If he steadfastly refuses to back any federal action to deal with the growing epidemic of teen smoking, which is apparently one cause of the escalation in hard drug use by teens, Dole's position will stand in stark contrast to that of a President who is prepared to take decisive action.
Thus it's no surprise that TV commercials slamming Dole for this position on tobacco have already been prepared for use in the upcoming election.
Virtually all the polls show that protecting children from becoming addicted to tobacco is popular with voters, especially female voters where Dole seems to be the weakest.
Indeed, the Washington Post reported yesterday that Clinton in doing well even in major tobacco-growing states like Kentucky.
In the long run, says law professor John Banzhaf, Executive Director of ASH, the greatest effect of the President's announcement may be on public's perceptions of smokers.
Images of macho men and slim sexy women may give way to a reality of drug addicts so desperate for their next fix that they cannot even go the day without it, as most heroin and cocaine addicts do.
The FDA's 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.
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.
Banzhaf also predicts that the U.S. Supreme Court's recent decision striking down a total ban on the advertising of liquor prices in order to discourage alcohol consumption by adults will not affect the FDA's rules.
These rules, notes Banzhaf, are designing to protect children rather than adults. Even more importantly, they do not þ unlike the liquor rules þ prevent the tobacco industry from providing any factual information to potential buyers. "Marlboro men, Virginia Slim women, and baseball caps with Joe Camel's picture present only emotional appeals, not factual information."
| ASH -
ACTION ON SMOKING AND HEALTH 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |