IS TOBACCO A DRUG?
articles intended for use as a component of any article specified inclause (A), (B), or (C) of this paragraph.
For purposes of the FDA’s assertion of jurisdiction over tobacco, thekey provision is clause (C), defining a drug as an “article[ ] . . . in-tended to affect the structure or any function of the body.” Is tobaccosuch an article? I will be urging here that the FDA has the legalauthority to answer this question either no or yes, and that its yes in1996 is therefore lawful.
B. Several Puzzles, and a Particular Dispute
The dispute over the authority of the FDA
to regulate tobaccoraises a number of questions—indeed, a remarkably high percentage
7.21 U.S.C. § 321(g)(1) (1994). This subsection goes on to explain that a “food or dietarysupplement . . . is not a drug solely because the label or the labeling contains such a claim.”
8.Ultimately, the FDA concluded that tobacco products are “combination products”involving drugs and devices.
note 4, at 44,403. I deal principallyhere with the issue of whether tobacco products qualify as “drugs.” An affirmative answer isthe basic predicate for FDA authority under the FDA’s conclusion that cigarettes are “devices”because “the primary purpose of parts of the cigarette . . . is to effectuate the delivery of a care-fully controlled amount of the nicotine to a site in the human body where it can be absorbed.”Analysis Regarding the Food and Drug Administration’s Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products, 60 Fed. Reg. 41,453, 41,522 (Aug. 11,1995) [hereinafter FDA Jurisdictional Analysis]. The statutory definition of “device” includes:[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro rea-gent, or other similar or related article, including any component, part, or accessory,which is –. . .(3) intended to affect the structure or any function of the body of man or other ani-mals, andwhich does not achieve its primary intended purposes through chemical action withinor on the body or man or other animals and which is not dependent upon being me-tabolized for the achievement of its primary intended purposes.21 U.S.C. § 321(h) (1994). I do not discuss this provision, except to suggest that if the FDA isauthorized to define tobacco products as a drug, it is almost certainly authorized to treat suchproducts as “combination products” subject to its device authority.
note 1, at 44,402 (explaining FDA jurisdiction over combination products).9.In its remarkably broad opinion, completed as this Article went to press, the court ofappeals invalidated the FDA regulation on various grounds.
Brown & Williamson TobaccoCorp. v. FDA, Nos. 97-1604, 97-1581, 97-1606, 97-1614, 97-1605, 1998 WL 473320, at *1 (4thCir. Aug. 14, 1998). The points made by the court are discussed at separate places below; Iidentify the elements of the court’s analysis here, and also the places where these are ad-dressed, and I make a few supplemental points.The most striking feature of the court’s approach is its failure to deal with the languageof the key provision of the statute, an especially striking omission in light of the court’s admis-sion that the “literal” language of the statute strongly supports the FDA.
See Brown & Wil- liamson
, 1998 WL 473320, at *4. An especially disturbing feature of the court’s opinion is the