By a narrow 5-4 vote, the top U.S. court has thrown out attempts by the U.S. FDA to regulate tobacco products as a combination drug/drug delivery advice.

The Supreme Court majority accepted the tobacco industry’s rather astonishing arguments that tobacco products are simply too dangerous to regulate, and that the FDA would be forced to ban them outright if it was able to assert jurisdiction:

“...once the FDA fulfilled its statutory obligation to classify tobacco products, it could not allow them to be marketed.”

The FDA has always stated that it has no intention of banning tobacco products, given the expected negative effects of such a ban (a huge black market, etc.). The Supreme Court majority rejected this view:

“Several provisions in the Act require the FDA to determine that the product itself is safe as used by consumers. That is, the product’s probable benefits must outweigh its risk of harm... [A]lthough the FDA has concluded that a ban would be ‘dangerous,’ it has not concluded that tobacco products are ‘safe’ as that term is used throughout the Act.”

But since there is lots of evidence that Congress does not want an outright ban on tobacco products, Congress clearly does not intend to give the FDA jurisdiction over tobacco products, the majority ruled.

Nicotine is a drug, minority says

The dissenting minority rejected this line of argument outright:

“This argument is curious because it leads with similarly ‘inescapable’ force to precisely the opposite conclusion, namely, that the FDA does have jurisdiction but that it must ban cigarettes. More importantly, the argument fails to take into account the fact that a statute interpreted as requiring the FDA to pick a more dangerous over a less dangerous remedy would be a perverse statute, causing, rather than preventing, unnecessary harm whenever a total ban is likely the most dangerous response.”

The minority also ruled that nicotine meets the legal test to qualify as a drug, in particular because it is a chemical agent designed to affect the body. It rejected the manufacturers’ claim that tobacco products were outside FDA jurisdiction because the manufacturers are not making explicit health claims for their products. The important test, the minority ruled, is whether a product is intended to affect the body:

“[C]onsumers have come to understand what the companies no longer need to express—that through chemical action cigarettes stabilize mood, sedate, stimulate, and help suppress appetite.”

What happens next, and what does this mean for Canada?

As soon as the Supreme Court decision was announced, U.S. tobacco stocks rose sharply, only to fall off again within a few hours, reflecting ongoing worry about a slew of other legal cases, including a California lawsuit that is going against the industry.

The U.S. Supreme Court decision essentially puts the job of regulating tobacco products into the hands of legislators; the narrowness of the decision will doubtless help keep the issue high on the political agenda. Given the tobaccco industry’s ongoing decline in public favour, a bill giving the FDA or some other government authority the right to regulate tobacco would have a much better chance of passing than it would have had in the past.

In Canada, it is worth noting, Health Canada already has the authority under the Tobacco Act (Bill C-71) to do essentially everything the FDA was claiming jurisdiction over in the United States. For example, the government could decide tomorrow that it wished to impose product modifications on the industry via regulation.

In the long term, then, the tobacco industry’s successful argument that cigarettes are simply too dangerous to regulate in the way that analogous products are treated is likely to do more harm than good to the industry’s interests.

Full text of the U.S. Supreme Court decision, as well as the dissenting opinion, are available on-line at the Legal Information Institute: FDA v. Brown & Williamson Tobacco Corp.