Court Opinion

ID: 6973596
Source: CourtListenerOpinion
Date Created: 2022-07-24 02:06:58.60317+00
Date Added: 2024-06-11T16:08:53.317974
License: Public Domain

K.K. HALL, Circuit Judge,
dissenting:
The FDCA delegates to the FDA the duty of promulgating and enforcing regulations aimed at protecting the nation’s citizens from misbranded and unsafe drugs and food. After years of considering an array of evidence, much of it only recently brought to light, the FDA decided to regulate a product that is estimated to cause some 400,000 deaths a year. While not actually disputing that tobacco products deliver a drug, nicotine, into the body, the majority would deny to the FDA the authority to act to address this acknowledged health threat. I dissent.
Tobacco- products fit comfortably into the FDCA’s definitions of “drug” and “device.” Inasmuch as cigarettes and smokeless tobacco are responsible for illness and death on a vast scale, FDA regulations aimed at curbing tobacco use by children cannot possibly be contrary to the general intent of the FDCA to protect the public health. But even when we expand our search for legislative intent beyond the words of the statute, the evidence falls far short of demonstrating that Congress intended to deny or withdraw jurisdiction over tobacco from the FDA. Therefore, *177on the major question before us, I would affirm the district court’s denial of summary judgment to the companies to the extent such judgment turns on the issue of the FDA’s authority to regulate tobacco products.
As a consequence of this view, I must also reach those subordinate issues not discussed by the majority. I would affirm the denial of summary judgment to the companies on the issue of the FDA’s choice of the “combination-products” regulatory scheme. I believe, however, that the district court erred in ruling that the FDA cannot, as a matter of statutory law, restrict the advertising of tobacco pursuant to the agency’s authority to regulate the “sale” of such products.
I
When reviewing an agency’s construction of -a statute, we must first ask “whether Congress has directly spoken to the precise question at issue.” Chevron, U.S.A., Inc., v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). The usual rule is to enforce the plain language of a statute according to its terms. United States v. Ron Pair Enters., Inc., 489 U.S. 235, 241, 109 S.Ct. 1026, 103 L.Ed.2d 290 (1989). Whether the language is plain is “determined by reference to the language itself, the specific context in which the language is used, and the broader context of the statute as a whole.” Robinson v. Shell Oil Company, 519 U.S. 337, 117 S.Ct. 843, 846, 136 L.Ed.2d 808 (1997). Here, the language is plain, and the context does not command a result contrary to the plain meaning.
The majority devotes approximately three paragraphs to the words that form the heart of the FDA’s jurisdictional claim: “[T]he term ‘drug’ means ... articles (other than food) intended to affect the structure or function of the body.” 21 U.S.C. § 321(g)(1)(C). While as much as conceding that tobacco products fit the FDCA’s “literal” definition of drug, the majority concentrates instead on what it believes is abundant evidence elsewhere demonstrating that Congress has never intended that tobacco come under FDA authority. Despite the apparent agreement about the “literal” meaning of “drug” and “device,” a few words are necessary to set the stage before moving on to a discussion of the “context” of the FDCA.
A
The rulemaking record contains voluminous evidence of the pharmacological effects of nicotine; in addition to being highly addictive, nicotine acts as a stimulant, tranquilizer and appetite suppressant. See 61 Fed.Reg. 44665-66 (1996). Under these assumed facts, nicotine clearly “affect[s] the structure or function of the body of man ... ”, and I do not understand the majority to be saying otherwise. The only arguable impediment to a complete fit between the terms of the statute and tobacco products is the word “intended.”
B
Building on the conclusion that the nicotine in tobacco products is highly addictive, the FDA proffered four independent rationales to satisfy the additional requirement that tobacco products be “intended” to affect the body: (1) a reasonable manufacturer would foresee that consumers would use the product to satisfy addiction, see 61 Fed.Reg. 44634, 44701-39; (2) most consumers do in fact use tobacco products to satisfy addiction, see id. at 44233; (3) the manufacturers have long known that consumers use the.products for the pharmacological effects, see id. at 44849; and (4) the manufacturers design the products to deliver active doses of nicotine, see id. at 44951. On reasoning with which I agree, the district court held that the FDA could proffer evidence in support of the first and second of these rationales. Coyne Beahm, 966 F.Supp. at 1388-92. In addition, I would also permit the use of recently disclosed evidence, including heretofore-secret company documents, that establish that the companies have known about the addictive qualities of their products for years and that cigarettes are deliberately manipulated to create and sustain addiction to nicotine.
My dictionary contains the following definitions of “intend”: “1. To have in mind: PLAN. 2a. To design for a particular pur*178pose. b. To have in mind for a particular purpose.” WebsteR’s II New RiveRSIde University Dictionary (1984). As a matter of simple English, the resultant effect on the body — nicotine addiction — is intended when the manufacturer (as we are assuming for the purposes of this appeal) deliberately designs the product to have that effect. This meaning is the primary, literal, and most common one attached to the word “intend,” and it is ordinarily the one we should use. See Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187, 115 S.Ct. 788, 130 L.Ed.2d 682 (1995) (“When terms used in a statute are undefined, we give them their ordinary meaning.”). The majority’s argument does not convince me that we should abandon this common sense rule in this situation.
Prior to these rules, the FDA had “asserted jurisdiction over cigarettes only when health claims were made by the vendors or manufacturers.” Action on Smoking and Health v. Harris, 655 F.2d 236, 239 & n. 7 (D.C.Cir.1980) [hereinafter ASH] (citing as examples United States v. 354 Bulk Cartons Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D.N.J.1959), in which cigarettes were marketed as weight reduction aids, and United States v. 46 Cartons Fairfax Cigarettes, 113 F.Supp. 336 (D.N.J.1953), in which cigarettes were marketed as helping to prevent respiratory diseases). No other court, however, has been confronted with the type and quantity of evidence collected during the rulemaking process in this case; the strength of nicotine’s addictive qualities, the extent of the health problems created by tobacco products, and the complicity of the manufacturers bring us to a different place than we have been before.
Products deliberately designed to create and sustain addiction are not likely to be marketed as such; indeed, such products are more likely listed elsewhere in Title 21 among the illegal controlled substances. It strikes me as patently absurd to contend that cigarettes and smokeless tobacco, products that are (under the assumed facts) actually designed to exert powerful and quintessentially drug-like effects on the users, should escape FDA regulation because the products are marketed as essential accoutrements of a more exciting or more sophisticated lifestyle.
II
Tobacco products, then, come squarely within the plain terms of the FDCA. If the words of a statute are plain, “absent any ‘indication that doing so would frustrate Congress’s clear intention or yield patent absurdity, our obligation is to apply the statute as Congress wrote it.’” Hubbard v. United States, 514 U.S. 695, 703, 115 S.Ct. 1754, 131 L.Ed.2d 779 (1995) (quoting BFP v. Resolution Trust Corporation, 511 U.S. 531, 570, 114 S.Ct. 1757, 128 L.Ed.2d 556 (1994) (Souter, J., dissenting)), quoted in Dunn v. Commodity Futures Trading Commission, 519 U.S. 465, 117 S.Ct. 913, 916, 137 L.Ed.2d 93 (1997). The questions, then, should be: Does upholding FDA jurisdiction over tobacco frustrate clear congressional intent to withhold such jurisdiction? Is it patently absurd? Does it “conflict with any other section of the Code, or with any important state or federal interest, [or] is a contrary view suggested by the legislative history[?]” Ron Fair, 489 U.S. at 243, 109 S.Ct. 1026. In other words, given the plain language used in § 321(g)(1)(C), the question should be whether the intent manifested by the words used— that tobacco products are “drugs delivery devices” subject to FDA regulation — is trumped by evidence to the contrary.
The majority seeks to show that the “context” of these readily understood words demonstrates that Congress really meant something else where tobacco is concerned. This search for context takes us into “the overall regulatory scheme created by Congress” (Maj. op. at 163) and “the history of evolving congressional regulation in the area” (Maj. op. at 162) (citation omitted), the legislative history of the FDCA and related statutes, and even congressional inaction. I will address each avenue explored by the majority.
A
The majority opens with this argument: The FDA’s mandate is to prevent the marketing of any drug or device that is found to be unsafe; tobacco products are unsafe; to *179allow the continued sale of cigarettes is completely at odds with such mandate; ergo, the regulations must be struck down. But whether the regulations contravene the statute is a question wholly apart from whether any regulations could be issued. How the FDA has chosen to regulate tobacco has no bearing on the question of whether that agency has the authority to regulate it at all, particularly when it is agreed that the power to regulate under the FDCA includes the power (under the assumed facts) to ban tobacco products completely. The FDA made an eminently reasonable decision to focus on preventing addiction among children while permitting sales to adults. See Fed.Reg. 44398-99, 44412-13. It is no argument to say that the FDA can do nothing because it could have done more.
B
The majority’s analysis of the “extrinsic evidence” of congressional intent stands on three legs: The lack of any mention of tobacco in the statute itself or the legislative history of the 1938 Act; the FDA’s consistent disavowal of any intention of taking jurisdiction over tobacco, and, concomitantly, the general assumption that the agency was right; and the series of tobacco-related statutes enacted over the last thirty years.1

The FDCA

In construing remedial legislation, we must be ever mindful of the salutary purpose of the statute.
The historical expansion of the definition of drug, and the creation of a parallel concept of devices, clearly show, we think, that Congress fully intended that the Act’s coverage be as broad as its literal language indicates — and equally clearly, broader than any strict medical definition, might otherwise allow. [W]e are all the more convinced that we must give effect to congressional intent in view of the well-accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act’s overriding purpose to protect the public health....
United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969).2 The majority starts off on the wrong foot when it asks “whether Congress intended to delegate jurisdiction over tobacco products to the FDA.” Maj. op. at 162.
Congress did not “intend” that any particular product be included; as. the district court noted, “[rjather than itemize each product subject to regulation under the FDCA, Congress defined these categories broadly , so that each encompasses a wide range,of products.” Coyne Beahm v. FDA, 966 F.Supp. at 1380. An exhaustive list of covered products was neither feasible nor necessary; effective regulation required flexibility within broad parameters.
Pointing out the obvious — that the FDCA was not originally directed at tobacco — gets us nowhere. No one contends that Congress foresaw in 1938 that tobacco was or might someday be included as a “drug”1 under the FDCA. The operative congressional intent at the outset was simply to confer broad discretionary powers on the FDA to regulate “drugs” and “devices.” The FDCA was written broadly enough to accommodate both new products and evolving knowledge about existing ones, and it was written that way on purpose.

*180
FDA’s Prior Position

Until the rulemaking began in 1995, the FDA had interpreted the FDCA to include tobacco products only when health claims were made. See Maj. op. at 168-69. The agency’s refusal even extended to opposing citizens’ petitions to regulate cigarettes on essentially the same basis that is used in the regulations today. See, e.g., ASH, 655 F.2d at 236. The agency’s current position is a response to the increasing level of knowledge about the addictive nature of nicotine and the manufacturer’s deliberate design to enhance and sustain the additive effect of tobacco products. When the early tobacco-specific statutes were being debated in Congress, the essential link between tobacco and illness had not yet been proven to the satisfaction of all. For instance, during the floor debate on amendments to the FCLAA, Rep. Perkins stated that
[i]t is my feeling that not one of the tobacco farmers in my district would knowingly produce any commodity which, when consumed, would cause the dread diseases which have been claimed to be associated with tobacco. But the claims ... are not proved. Tobacco has been impeached in passion but it had not been convicted in fact. Facts, cold hard facts are the basis upon which congress should legislate.
Cigarette Labeling and Advertising: Hearings Before the House Comm, on Interstate and Foreign Commerce, 91st Cong. 16 (1969). Well, the “cold hard facts” are now in.
It is a familiar canon of administrative law that an agency can change its view of what action is possible or necessary, particularly when new facts come to light. See Rust v. Sullivan, 500 U.S. 173, 186-87, 111 S.Ct. 1759, 114 L.Ed.2d 233 (1991) (“An agency ... must be given latitude to adapt its rules and policies to the demands of changing circumstances”) (citations and internal quotation marks omitted). Even when upholding the FDA’s earlier denial of its own power to regulate tobacco, the court added the following caveat:
Nothing in this opinion should suggest that the[FDA] is irrevocably bound by any long-standing interpretation and representations thereof to the legislative branch. An administrative agency is clearly free to revise its interpretations.... The very structure of the [FDCA] which the FDA must administer, moreover, calls for case-by-case analysis. Should an agency depart from its prior interpretations, however, it must provide a reasoned explanation for its action_[citations omitted],
ASH, 655 F.2d at 242 n. 10.
Under the facts found by the FDA during the rulemaking process, it is now a scientific certainty that nicotine is extremely addictive and that a large majority of tobacco users use the product to satisfy that addiction; even more important to my mind is the new evidence that the manufacturers design their products to sustain such addiction. The administrative record in this ease is a perfect illustration of why an agency’s opportunity to adopt a new position should remain open.

The Tobacco Statutes

As products of the democratic process, each tobacco-specific statute is a balance of health, economic, and other concerns. The majority cites this body of legislation as “corroborating evidence of established congressional intent” to withhold jurisdiction over tobacco from the FDA. Maj. op. at 171. Again, I think the majority’s approach ignores the fundamental source of intent, the words of the statute itself. Nevertheless, closer examination of these tobacco statutes reveals that they form something less than Congress’s “comprehensive program” to address the tobacco problem. Absent a dis-cernable intent to exclude future FDA action,3 that these statutes were written with knowledge that the FDA forswore jurisdiction over tobacco does not supply that intent.
*181The first in this series, the Federal Cigarette Labeling and Advertising Act (FCLAA),4 was enacted in response to the Surgeon General’s ground-breaking 1964 report linking smoking to health problems. The companies describe it as a statute that “set the boundaries of the federal regulatory role,” “clearly expresses a congressional intent that precludes FDA jurisdiction over tobacco products,” “embodied the view that Congress, itself, should retain all policy making authority as to tobacco, even in areas open to regulation,” “ratified the established understanding that FDA does not have jurisdiction over tobacco products,” “ruled out any later reading of the FDCA as an ‘implicit’ delegation to FDA ... of authority to decide whether or how to regulate tobacco products and whether to ban them.” Companies’ Opening br. 13, 18-20. An examination of the statute reveals something considerably more modest, something that will not bear anything approaching the weight placed upon it by the companies or the majority.
The majority’s focus- is § 1331, which reads:
It is the policy of the Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby—
(1) the public may be adequately informed about any adverse health effects of cigarette smoking by inclusion of warning noT tices on each package of cigarettes and in each advertisement of cigarettes; and
(2) commerce and the national economy may be (A) protected to the maximum extent consistent with this declared policy and (B) not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.
This is a far cry from a comprehensive federal tobacco program; it is little more than a mild response to one of the earliest official recognitions of an emerging health issue.
The narrowness of the FCLAA was emphasized in Banzhaf v. FCC, 405 F.2d 1082 (D.C.Cir.1968), where the court was confronted with a post-FCLAA ruling by the FCC that required radio and television stations that carried cigarette commercials to devote significant broadcast time to permit the case to be made against smoking. Then, as they do today, the tobacco companies argued that the FCLAA embodied a clear congressional intent to preclude intrusions into the regulation of tobacco by any agency. See id. at 1088. Judge Bazelon, however, saw things differently:
[Tjhere are positive indications that Congress’s “comprehensive program” was directed at the relatively narrow specific issue of regulation of “cigarette labeling and advertising.” ... Nothing ■ in the [FCLAA] indicates that Congress had any intent at all with respect to other types of regulation by other agencies — much less that it specifically meant to foreclose all such regulation. If it meant to do anything so dramatic, it might reasonably be expected to have said so directly....
Id. at 1089 (footnotes omitted) (quotations in original).5 The next thirty years would see several more small steps that, even when considered together, fall far short of a comprehensive program, and even shorter of a demonstration that Congress intended to preclude the exercise of jurisdiction now being asserted by the FDA. '
Following the FCLAA, the next step in what the companies characterize as Congress’s ongoing program was the Public Health Cigarette Smoking Act of 1969, which amended the FCLAA in response to proposed incursions into the field by the FCC and FTC by way of proposed regulations that would have restricted tobacco advertising. Again, Congress addressed only advertising, this time in the electronic media, and *182short-circuited the roles proposed by the agencies for themselves.
Thirteen years later, Congress enacted the Alcohol and Drug Abuse Amendments of 1983, which simply directs the Secretary of HHS to report to Congress every three years on “the health consequences of drug abuse in the United States [and] current research findings made with respect to drug abuse, including current findings on ... the addictive property of tobacco” and to' include recommendations for “legislation and administrative action as the Secretary may deem appropriate.” 42 U.S.C. § 290aa-2(b). This does not, as the majority asserts, “evidence[ ] Congress’ ... intent to retain control over further regulatory action.” Maj. op. at 174. It is more an acknowledgment that because the HHS (and the FDA), as‘the experts in the complex field of drug abuse, had and would continue to have a crucial role to play, the Secretary was required to ask Congress for any additional tools it needed get to perform that role effectively.
The Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 [ADAMHA], the last brick in the purported congressional tobacco program, provides financial incentives to the States to enforce their own restrictions on access to tobacco by minors. The majority argues that the FDA regulations would conflict with this congressional determination that the States should take an active role in addressing the youth access problem because the FDCA preempts any different restrictions on devices. See 21 U.S.C. § 360k(a). This overstates the case.
ADAMHA restructured block grant programs aimed at substance abuse and mental health services; only a few provisions relate to underage smoking. See 42 U.S.C. § 300x-26. ADAMHA does not demonstrate an intent on Congress’s part -that the states “take the primary role” in addressing the problem of underage smoking, and it certainly does not “establish” a regulatory role for the states. Maj. op. at 175-76. Although the FDA’s proposed regulations would preempt some state laws, the exercise of FDA authority over tobacco would not “prohibit the States from addressing the problem of youth access.” Id. The proposed rule can co-exist with most of the states’ separate laws prohibiting sales to minors and imposing other restrictions on tobacco sales. Even the few more stringent state or local restrictions that are preempted by the FDA’s proposed regulations (see 61 Fed.Reg. 44548-50) might qualify for an exemption from preemption, thereby further minimizing conflicts. See 21 U.S.C. § 360k(b). An overlap between two regulatory systems does not require wholesale jettisoning of one in favor of the other. See Connecticut Nat’l Bank v. Germain, 503 U.S. 249, 253, 112 S.Ct. 1146, 117 L.Ed.2d 391 (1992) (“Redundancies across statutes are not unusual events in drafting, and so long as there is no ‘positive repugnancy’ between two laws, a court must give effect to both”) (internal citation omitted).
C
Tobacco is different from the articles commonly associated with the word “drugs,” the FDA regulations are indeed the result of turnaround in agency thinking, and tobacco was most probably not on anyone’s mind when the FDCA was enacted. But the FDCA was broadly worded by design. In an area in which complex new products (and old products, seen in the light of new evidence) pose the potential for grievous harm, Congress' deemed it necessary to delegate to an expert — the FDA — the job of monitoring drugs. Cigarettes and smokeless tobacco clearly fit within the literal terms of the FDCA. Absent a showing that following these statutory terms would be absurd or somehow frustrate congressional intent, we are bound to uphold FDA jurisdiction.
The FDA’s denials that it had any authority over tobacco were certainly part of the background against which Congress passed tobacco-related legislation in the thirty years following the Surgeon General’s 1964 report, but this series of statutes is hardly an argument for “legislative ratification” (Maj. op. at 170 n.18) of the FDA’s prior position that the agency was powerless to act. It is agreed, moreover, that an agency is permitted to change its mind, particularly in response to new facts, so the real question is whether all *183that has gone before — the tobacco statutes, the consistent .denials by :the FDA — is sufficient to demonstrate a clear intent on Congress’s part to preclude FDA jurisdiction. The evidence offered by the companies falls far short.
III
Having decided that the FDA has no jurisdiction over tobacco products, the majority had no reason to address whether cigarettes and smokeless tobacco were “devices” and whether the choice of regulatory regime — as-a combination product, pursuant to the device authorities — was permissible. I agree with and adopt the district court’s reasoning on these points entirely. See Coyne Beahm, 966 F.Supp. at 1393-97.
IV
Another issue not reached by the majority is whether the FDA may restrict the advertising of tobacco products.6 On this point, I disagree with the district court’s conclusion that the advertising regulations exceeded the FDA’s statutory authority.
The FDA found that “cigarette and smokeless tobacco use begins almost exclusively in childhood and adolescence.” 61 Fed.Reg. 46239. Minors are particularly vulnerable to Madison Avenue’s exhortations, plastered on racing cars and outfield fences, to be cool and smoke, be manly and chew, and the FDA found “compelling evidence that promotional campaigns can be extremely effective in attracting young people to tobacco products.” Id. at 45247.7 The FDA chose to attack the problem by attempting to reduce the pressures to start using tobacco in the first place.
The pertinent portion of the of the 1976 Medical Device Amendments, 21 U.S.C. § 360j(e), provides:
The Secretary may by regulation require that a device be restricted to sale, distribution, or use ... [by prescription] or upon such other -conditions as. the Secretary may prescribe in such regulation, if, .because of its potentiality for harmful effect or the- collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness.
The FDA relies on this section as authority for the regulations restricting the advertising of tobacco products, its rationale being that the authority to restrict the “sale” of or to impose “other conditions” on a product includes within it the authority to restrict the means by which such sales are generated.
Examples of obviously permissible restrictions of the “sale” of a product are regulations regarding where, when, by whom, and to whom a product can be sold. But is a restriction on advertising a restriction of the “sale” of a product? The district court found that the plain meaning of the words precluded advertising restrictions: “Both as ordinarily defined and as used in the phrase ‘may .. -be restricted to sale, distribution, or use,’ the word ‘sale’ does not encompass the advertising or promotion of a product.” Coyne Beahm, 966 F.Supp. at 1398 (footnote omitted). But even the dictionary entiy cited in the district court’s opinion defines “sale” as “the act of selling”; the term “sales” is defined as “[ajctivities involved in the selling of goods and services.” Id. at 174 n. 23. Under a Chevron step-two analysis — “if the statute is silent or ambiguous with respect to the specific issue, the question is whether the agency’s answer is based on a permissible construction of the statute[,]” Chevron, 467 U.S. at 843, 104 S.Ct. 2778 (footnote omitted) — we need only find that the. agency construction is a reasonable one, not the best one. See id. at 163 n. 11. I believe the term “sale” is ambiguous enough to encompass the concept of “offer for sale.”
*184The district court also distilled an intent to withhold the authority asserted by the FDA from the use of the terms “offer for sale” and “advertising” elsewhere in 1976 legislation. See Coyne Beahm, 966 F.Supp. at 1398-99. However, while the “language and design of the statute as a whole” (K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 291, 108 S.Ct. 1811, 100 L.Ed.2d 313 (1988)) might raise a question about the extent of the FDA’s authority in this area, it does not mandate a conclusion that Congress intended to foreclose the FDA from imposing advertising restrictions. There is simply no conclusive evidence of intent either way; the phrase is sim ply ambiguous, both in isolation and with reference to the context in which it is used.
The term “sale, distribution and use,” which is used only once in the entire FDCA, can reasonably be construed to include all aspects of a product’s journey from the factory to the store and to the home. As I have noted above, tobacco is different from the run-of-the-mine drugs and devices in the FDA’s bailiwick, and the nature of the differences dictate new approaches to fight the dangers posed. Because the precise approach chosen might not have been considered by the drafters of the statute does not necessarily preclude it. The interpretation is a reasonable one and, therefore, we must defer to the agency.
V
I would affirm the district court’s judgment to the extent that it denies summary judgment to the tobacco companies on the issues of the FDA’s authority to regulate tobacco products under the FDCA and to regulate such products as “combination products.” I would vacate the judgment below to the extent it grants summary judgment to the companies on the issue of the FDA’s authority to regulate the advertising of tobacco products.

. As a corollary to this third point, the majority also relies on congressional refusal to enact legislation that would have expressly given the FDA the authority it now claims. See Maj. op. at 169-71. To whatever extent this inaction may be interpreted as "ratification” of the FDA’s prior (no tobacco jurisdiction) position, it would appear that Congress's continued inaction in the face of all that has followed the FDA’s announcement of the proposed rule three years ago (see 60 Fed.Reg. 41314) would more than offset any ratification effect to be gleaned from the earlier inaction.

. Justice Frankfurter put it this way:
The purposes of this legislation [FDCA] thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.
United States v. Dotterweich, 320 U.S. 277, 280, 64 S.Ct. 134, 88 L.Ed. 48 (1943).

. Congress certainly knows how to exempt tobacco. The only mention of tobacco in the FDCA was added in 1994 to explicitly remove tobacco from the new exemption of "dietary supplements” from the definition of "drug.” See Pub.L. No. 103-407, § 3(a), 108 Stat. 4325, 4327 (codified at 21 U.S.C. § 321(ff)). The criminal laws regarding narcotics incorporate the definition of "drug” found in the FDCA, see 21 U.S.C. § 802(12), but the definition of “controlled substance,” which includes "a drug,” specifically excludes tobacco. See 21 U.S.C. § 802(6).

. The Comprehensive Smokeless Tobacco Health and Education Act, 15 U.S.C. §§ 4401-4407, more or less mirrors the FCLAA.

. In Cipollone v. Liggett Group, Inc., 505 U.S. 504, 514, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), the Court described the purposes of the FCLAA as informing the public of the health risks and "protecting the national economy from the burden imposed by diverse, nonuniform, and confusing cigarette labeling advertising regulations" [footnote omitted].

. In view of its ruling on statutory grounds, it was unnecessary for the district court to reach the companies’ constitutional objections to the advertising restrictions. Coyne Beahm, 966 F.Supp. at 1400 n. 33. Because neither party has briefed the First Amendment issue, I do not discuss it here.

. For example, one study cited in the rulemaking record found that "30% of 3-year-olds and 91% of 6-year-olds could identify Joe Camel as a symbol for smoking.” Id. at 45246 (citing Fischer, Schwartz & Richards, Brand Logo Recognition by Children Aged 3 to 6 Years, Mickey Mouse and Old Joe the Camel, Journal of the American Medical Association, 1991).