The Supreme Court has set the stage for a momentous ruling next year not only on whether the Food and Drug Administration can regulate tobacco — and perhaps even ban it someday — but also, more broadly, on the powers of the President and his appointees to make law without a clear congressional mandate.
     
This is one of those hard cases that is likely to make bad law no matter how well the Justices do their jobs. A win for either side might well have important — and troubling — consequences.

A victory for the Clinton FDA could indirectly diminish the role and stature of the legislative branch by pushing to new heights the powers of executive branch agencies to make law. An FDA loss, on the other hand, could result in more tobacco addiction and tobacco-related deaths than would otherwise occur, and could cast a legal cloud over other agencies’ bold initiatives.

The best (if least likely) outcome would be for Congress to moot this case by shaking off the partisan paralysis into which it has sunk — on issues ranging from Kosovo to Social Security — and passing a comprehensive, regulatory regime specifying how the FDA and other agencies should seek to cut down the tobacco death toll of 400,000 Americans a year.

But Congress failed to do that last year — in part because so many members are addicted to tobacco money. One result was a policy vacuum, which was partially filled by the far-from-perfect $208 billion financial settlement last November to end the lawsuits by 46 state attorneys general against the tobacco industry. The settlement included some advertising restrictions but no comprehensive plan to protect children from tobacco addiction.

Another result was to prolong unnecessarily the lawsuit to determine whether Congress unwittingly gave the FDA jurisdiction to regulate tobacco 61 years ago when it passed a statute that was long thought to do nothing of the sort.

The Justices signaled their intention to decide that lawsuit on April 26, when they granted the Clinton Administration’s petition (supported by 39 states) to review a 2- 1 federal appeals court ruling last August that the FDA had no jurisdiction to regulate tobacco in any way. The immediate effect was to void the FDA’s 1996 restrictions on the retailing and display of tobacco to minors. The Court will hear arguments this fall in the case FDA vs. Brown and Williamson Tobacco Corp.

The FDA’s related ban on the types of tobacco advertising and promotion that it determined were the most attractive to minors (set aside on narrower grounds in 1997, by a federal district judge) is not currently before the Court. If the Justices uphold the FDA’s basic jurisdiction to regulate tobacco, the agency could then ask the appeals court to reinstate the advertising ban. That would mean a new round of judicial proceedings, leaving the legality of the advertising rules unresolved until 2001 or 2002.

Such is the pace of litigation in America — especially when Congress leaves the law unclear.

The high-powered legal teams representing both sides in the FDA vs. tobacco case have taken the raw materials of legislative history, evidence, and legal precedent and crafted powerful arguments of policy and principle.

"Unless reversed by this Court," Solicitor General Seth P. Waxman wrote in the FDA’s petition for review, "the panel’s ruling will deprive the public of an unparalleled opportunity to prevent millions of children from beginning a highly addictive habit that often leads to premature death…. Every year, approximately one million children and adolescents begin to smoke, and one out of every three such persons will eventually die prematurely from a tobacco-related disease."

"To the contrary," retorted a joint brief by tobacco companies and retailers, " ‘the public’ — through its elected representatives in Congress — has already addressed the complex and highly political issues of tobacco and health, including underage access. In a series of tobacco-specific statutes in 1965, 1970, 1983, 1984, 1986, and 1992, Congress crafted a national regulatory policy premised on the continued availability of tobacco products, even though they are deemed to be unsafe. .. . Congress gave FDA no role in the Administration of these statutes or this policy…. FDA simply seeks to supplant enacted policy by disregarding statutes with which it disagrees and short-circuiting an on-going political process…. This is not consistent with democratic lawmaking."

Down in the details, the FDA may have the better of the legal argument, but not by much.

It’s true, as the tobacco companies stress, that Congress has never passed a law with any specific intention of authorizing the FDA to regulate tobacco products; that Congress did not have tobacco in mind when it specified the FDA’s regulatory powers in the Federal Food, Drug, and Cosmetic Act of 1938; that the FDA itself consistently denied for many years that it had any jurisdiction over tobacco; and that Congress has apparently proceeded on the same assumption when it has passed laws such as the one that requires warning labels on tobacco products.

All of this casts some doubt on the FDA’s current view that in the 1938 law, Congress gave it the power to regulate tobacco products and even (if the FDA chooses) to ban them.

But it’s also true, as Waxman points out, that the 1938 law is worded broadly enough to give the FDA jurisdiction over tobacco products, given what we have learned since 1938 about the workings of tobacco inside the human body and the long-secret internal workings of the tobacco industry.

The 1938 law authorizes the FDA to regulate as "drugs" or "devices" any products that are "intended to affect the structure or any function of the body." Tobacco (we now know) affects the structure and functioning of the human body by causing and sustaining nicotine addiction and by acting as a sedative, stimulant, and appetite suppressant. We also know — from thousands of previously hidden documents that have come to light in recent years — that for decades tobacco companies have "intended" these drug-like effects, in the sense that, with full awareness of them, the companies have carefully engineered tobacco products to deliver nicotine in addiction-sustaining amounts.

All this, the FDA argues, brings tobacco within the 1938 law’s grant of broad generic jurisdiction to the FDA to regulate any product that is intended to have such drug-like effects, regardless of whether Congress had that particular product in mind when it adopted the law. And under Supreme Court precedents, the FDA argues, the various tobacco-specific laws passed by Congress since 1965 have little bearing on the case because none explicitly negated any part of the FDA’s jurisdiction under the 1938 law. Other precedents establish that agencies are free to change their minds about such matters if they have a reasonable explanation — in this case, the evidence that has come to light in recent years.

While the tobacco companies dispute all this, the most perversely persuasive point they make is that the regulatory regime set up by the 1938 law — aimed mainly at barring the prescription of drugs that had not been proven safe and effective — was not designed to deal with a clearly unsafe drug- delivery device such as tobacco.

In particular, the tobacco companies stress, the 1938 statute requires the FDA not to regulate but to ban any unsafe "drugs" within its jurisdiction. Since the FDA has found tobacco to be unsafe, the argument goes, it must either ban tobacco sales — a radical step that hardly anyone advocates — or recognize that tobacco is entirely outside of its jurisdiction.

The FDA’s answer is that a ban would endanger addicted users’ health, by forcing them into mass withdrawal or tempting them to buy especially unsafe black market cigarettes.

It’s not a very satisfying answer. Perhaps the best that can be said for it is that such twisting and turning by the FDA to fit tobacco into the 1938 law’s regulatory framework is the least-bad alternative to leaving a clearly dangerous drug- delivery device — the biggest cause of preventable death in America — totally untouched by the federal agency that Congress created to protect Americans from dangerous drugs.

The fundamental point is that no outcome in this case can be very satisfying as long as the FDA and the courts alike are forced to maneuver through a confusing and ambiguous patchwork of outdated statutes. The policy challenges posed by tobacco, which involve far-reaching economic as well as health consequences, call for the kind of coherent, national regulatory program that can most effectively and legitimately be devised by the legislative branch.