Basis for FDA's Jurisdiction Over Cigarettes is ASH Decision:

Basis for FDA's Jurisdiction Over Cigarettes is ASH Decision:

New Evidence is Exactly What Court Had in Mind in Cigarette Ruling

The Food and Drug Administration's determination that it has jurisdiction over cigarettes is based upon a 1980 Court of Appeals decision which, ironically, is frequently cited by the tobacco industry as proof that the agency lacks any power to regulate nicotine in cigarettes, as compared to nicotine in chewing gum, nicotine patches, or inhalants.

The answer, says law professor John Banzhaf who argued the case, is that while the court upheld the FDA's determination at that time that there was no evidence upon which to base jurisdiction, it recognized for the first time that so-called "objective evidence," of the type which has now come to light, could provide the basis for agency assertion of jurisdiction in the future.

Under the FDA statute, the term "drug" includes "articles (other than food) intended to affect the structure or any function of the body of man or other animals." [21 U.S.C. s 321(g)(1)(C)] This says Banzhaf requires a 2-part test.

First, the FDA must determine that the substance does in fact affect the functioning of the body. Since an expert panel at the FDA has already unanimously determined that it does, and any physician can measure changes in pulse rate, blood pressure, EKG, etc. immediately after a smoker lights up, this part of the test has never presented a problem.

Second, the FDA must also determine that the manufacturer intended the product to be used to cause these changes, and that these effects are not a totally unexpected and unwanted property. For example, although inhaling rubber cement or paint thinners can likewise cause similar bodily changes, these substances are not "drugs," because the manufacturers clearly do not intend them to be used in any way for this purpose.

Prior to a case known as Action on Smoking and Health v. Harris [655 F.2d 236], the FDA believed that, in determining the intent of the manufacturer, it could look only at the claims the makers chose to make. In other words, if tobacco companies carefully refrained from publicly claiming that smoking cigarettes helped users to lose weight, calm anxieties, or produce pleasant bodily sensations, the FDA could not find the requisite intent required by the statute.

But the court held for the first time in the Harris case that, in addition to scrutinizing "subjective vendor claims," the agency could also look at what the opinion called "objective evidence" that the drug-like effect were something the companies desired to cause.

Moreover, the court said that if "consumers use the product predominantly and in fact nearly exclusively" in order to obtain the drug effects of nicotine, then manufacturer intent may likewise be inferred.

Although the court held in 1980 that this type of evidence was not presented, Banzhaf argues that the many recently-revealed tobacco-industry documents now provide for the first time the type of "objective evidence" of the manufactures' intent which the decision had in mind.

Moreover, he says, it is now clear -- although it was not in 1980 ¾ that most people smoke because of the addictive nature of nicotine. Thus we can also infer manufacturer intent from this predominant purpose by smokers.

Although the court upheld the agency's determination based upon the then-available evidence that it did not have jurisdiction over cigarettes, the court clearly stated that the Administration is not "irrevocably bound" and "is clearly free to revise its interpretations" if it provides "a reasoned explanation for its action." The new documentary evidence provides this basis, argues Banzhaf.

Finally Banzhaf notes that the court said that the courts must give significant deference to the decisions of administrative agencies, and overturn them only if there is no substantial evidence to support them.

In the Harris case the agency had ruled that it had no jurisdiction, and thus Banzhaf and ASH had a great burden to overcome that deferential treatment.

Now, when the agency determines on the basis of all of this new evidence that it does have jurisdiction, it is that decision which must be given deference, and the tobacco industry in the one which must shoulder the burden of overcoming it.

FOR IMMEDIATE RELEASE: Thursday, August 3, 1995

FOR MORE INFORMATION, CALL: John Banzhaf (202) 659-4310

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