FDA v. Brown & Williamson Tobacco Corp. - Opinion Announcement

Argument of Speaker

Mr. Speaker: The opinion of the Court in No. 98-1152, Food and Drug Administration versus Brown & Williams Tobacco Corporation will be announced by Justice O’Connor.

Argument of Justice O'Connor

Mr. O'Connor: This case comes to us on writ of certiorari to the Court of Appeals for the Fourth Circuit.

In August 1996, the Food and Drug Administration published a final rule imposing regulations on the sale and marketing of tobacco products.

The FDA found that nicotine is a drug and that cigarettes and smokeless tobacco are devices that deliver nicotine to the body.

It concluded that it had jurisdiction to regulate tobacco products under the Food, Drug and Cosmetic Act.

A group of tobacco manufacturers, retailers and advertisers filed suit claiming among other things that the FDA lack the authority to regulate tobacco.

The Federal District Court rejected this contention, but the Fourth Circuit Court of Appeals reversed.

In an opinion file with the Clerk of the Court today, we affirm the judgment of the Court of Appeals.

Tobacco is perhaps the single most troubling public health problem our nation faces today, according to the FDA’s findings more than 400,000 Americans die each year from tobacco related illnesses such as cancer, respiratory illnesses and heart disease.

Indeed tobacco use is the leading cause of preventable death in the United States resulting in more deaths annually than Aids, car accidents, alcohol, homicides, illegal drug, suicides and fires combined.

But no matter how important the issue a federal administrative agency seeks to address, its power to regulate in a public interest must always be grounded in a valid grant of authority from Congress.

And in examining the Act as a whole as well as Congress’ more specific efforts to address the problem of tobacco and health it is clear that Congress never intended to delegate to the FDA the authority to regulate tobacco.

First, FDA jurisdiction over tobacco is incompatible with the Food, Drug and Cosmetic Act's over all regulatory scheme.

A fundamental precept of the Act is that all drugs or devices must be safe and effective for their intended use to obtain FDA approval.

The FDA’s findings concerning the health hazards of tobacco demonstrate however, that tobacco products are not safe and effective for any use.

Accordingly, were tobacco products with in the FDA’s jurisdiction, they would have to be removed form the market entirely, but Congress’ tobacco-specific statutes are expressly premised on the continued sale of tobacco products.

They therefore foreclose a ban.

To avoid this dilemma, the FDA has found that tobacco products are actually safe under the Act because in its opinion banning them would cause greater harm then leaving them on the market.

But the Act requires the FDA to conclude that the drug or device is safe, not that one remedial measure taken by the agency is less dangerous than another, that is to permit a product to be sold, the FDA must determine that at least for some consumers the therapeutic benefits from using it outweigh its risks to health.

The FDA cannot make such a finding for tobacco products, because according to its own findings cigarettes and smokeless tobacco are an unsafe means to obtaining any benefit or pharmacological effect.

The inescapable conclusion is that they are not devices within the meaning of the Act.

If tobacco products cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they just don’t fit within the FDA’s jurisdiction.

Moreover, Congress has specifically addressed the problem of tobacco and health in a manner that precludes any role for FDA regulation.

Since 1965, Congress has enacted six separate statutes addressed to the marketing and sale of tobacco products.

That legislation establishes a distinct scheme for the regulation of cigarettes and smokeless tobacco that focuses on product labeling and advertising.

As Congress enacted this legislation each time the FDA consistently, repeatedly, and resolutely stated that it had no authority to regulate tobacco.

Indeed from the enactment of the first Pure Food and Drug Act in 1908 until this rule making preceding, the FDA never want stated it had such jurisdiction and in passing these tobacco-specific statutes Congress several times explicitly considered and rejected bills that would have granted the FDA this authority.

In fact Congress consistently evidence its intent to preclude any agency from exercising significant policy-making authority in this area.

Congress has expressly preempted any other regulation of tobacco product labeling even though the regulation of labeling is a central aspect of FDA oversight.

Under these circumstances, it is evident that Congress never intended the FDA to have the power to regulate tobacco and instead ratify the FDA’s long-held position that it lacks such jurisdiction.

We do not question the gravity of the issue that the FDA has sought to address.

The FDA has demonstrated that tobacco use particularly among children and adolescents is a very serious problem.

But in pursuing its mandate to promote public health, the FDA may only exercise the authority that it has been granted by Congress.

In reading the Food, Drug and Cosmetic Act as a whole and in light of Congress' more specific tobacco legislation, we find it clear that for better or for worse Congress has not given the FDA the power to regulate tobacco.

Justice Breyer has filed a dissenting opinion, which Justices Stevens, Souter and Ginsburg have joined.

Argument of Justice Breyer

Mr. Breyer: As Justice O’Connor said, Justice Stevens, Justice Souter, Justice Ginsburg and I dissent.

The Act that we are interpreting says that drugs include "articles other than food intended to affect the structure or any function of the body."

That language applies to chemicals that affect the body after being metabolized and it therefore applies to the chemical nicotine in cigarettes, which physically changes the brain and consequently stabilizes mood, suppresses apatite, and satisfies an addictive craving that the nicotine itself has created.

Cigarette manufacturers intend both means and ends.

An intent revealed many years ago by express advertisements and which is reveal today by internal memoranda stating for example “Think of the cigarette as a dispenser for a dose unit of nicotine.”

This court has previously said that the Acts’ words weren’t “a liberal construction consistent with the Acts’ overwriting purpose."

That purpose, protecting the public health, strongly supports our dissenting conclusion.

For as Justice O’Connor pointed out, tobacco products cause more deaths each year than AIDS, car accidents, alcohol, homicides, illegal drugs, suicides and fires combined.

The history of this 1938 New Deal Act offers further support.

The majority believes that the statute does not fit cigarettes because it requires the FDA to ban a dangerous product.

Well the FDA itself believes that a ban is inappropriate for cigarettes.

That argument suggests limits upon FDA’s remedial discretion not upon its jurisdiction, but even if we are wrong about that we do not think that the Act requires a ban.

Imagine an addictive sleeping pill, which turned out to be dangerous and not very effective.

The FDA might decide against an immediate ban for fear of dangerous black-market substitutes choosing instead lesser remedies that would promote a gradual withdraw.

Why would Congress want to force the FDA to choose a more dangerous remedy?

The language of the statute does not require that reverse result, the majority also points to other statutes enacted more recently against the legislative background in which the FDA itself denied it had jurisdiction.

Those denials at most may have created a legislative atmosphere in which many members of Congress did assume that the FDA would not take jurisdiction, but a legislative atmosphere is not a law unless it is embodied in statutory words and phrases.

The statutory words and phrases that are here at issue are silent, they do not reveal an intent to prevent the FDA ever from exercising jurisdiction; they simply leave the matter untouched where they found it.

According to the FDA only 2.5% of all smokers successfully stop smoking each year, even though 70% say they want to quit and 34% actually make an effort.

That fact helps illustrate a certain hard reality that nicotine in cigarettes creates a powerful physiological addiction, flowing from chemically induced changes in the brain.

That reality, the FDA’s finding of intent, the statute's language, the statute's purpose, and the statute's history are sufficient to show regulatory jurisdiction.

The majority today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug nicotine and a device a cigarette that the majority itself finds unsafe.

Far more than most, this particular drug and device, risks the life-threatening harms that administrative regulation seeks to rectify.

The majority’s conclusion is counter-intuitive and we believe, in dissent, that the law does not require that result.

That is why we dissent.