Action on Smoking and Health v. Harris, No. 79-1397

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtBefore TAMM, ROBB and MIKVA; TAMM
Citation655 F.2d 236
PartiesACTION ON SMOKING AND HEALTH, Appellant, v. Patricia Roberts HARRIS, Secretary of the Department of Health and Human Services et al.
Docket NumberNo. 79-1397
Decision Date19 December 1980

Page 236

655 F.2d 236
210 U.S.App.D.C. 123
ACTION ON SMOKING AND HEALTH, Appellant,
v.
Patricia Roberts HARRIS, Secretary of the Department of
Health and Human Services et al.
No. 79-1397.
United States Court of Appeals,
District of Columbia Circuit.
Argued May 13, 1980.
Decided Dec. 19, 1980.

John F. Banzhaf, III, Washington, D. C., with whom Peter N. Georgiades, Pittsburgh, Pa., was on the brief, for appellant.

Margaret Halpern, Atty., U. S. Dept. of Justice, with whom John J. Powers, Atty., U. S. Dept. of Justice, Washington, D. C., Richard M. Cooper, Chief Counsel, Food and Drug Administration, and Joanne S. Sisk, Associate Chief Counsel, Food and Drug Administration, Rockville, Md., were on the brief, for appellees.

Before TAMM, ROBB and MIKVA, Circuit Judges.

Opinion for the court filed by Circuit Judge TAMM.

TAMM, Circuit Judge:

In this case the organization Action on Smoking and Health (ASH) challenges the refusal by the Food and Drug Administration (FDA) to assert jurisdiction over cigarettes containing nicotine as a "drug" under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 321(g)(1)(C) (1976). According the Administration's interpretation proper deference, we do not find this agency action arbitrary, capricious, or contrary to law and therefore affirm the judgment of the district court.

Page 237

I. BACKGROUND

On May 26, 1977, Action on Smoking and Health, in conjunction with thirteen other organizations and individuals, filed a citizen petition with the Food and Drug Administration requesting: (1) that the agency assert jurisdiction over cigarettes containing nicotine as a "drug" or a "device"; (2) that the agency regulate cigarettes no less strictly than saccharin; and (3) that the agency restrict the sale of cigarettes to pharmacies. 1 Citizen Petition, reprinted in Joint Appendix (J.A.) 1-43. ASH contended that section 201(g)(1) (C) of the Food, Drug, and Cosmetic Act (Act) provided the agency with the requisite jurisdiction over cigarettes as a drug. 2 In a letter memorandum dated December 5, 1977, however, the Commissioner of Food and Drugs, Donald Kennedy, rejected ASH's contention. The Commissioner based his rejection upon the agency's consistent position that cigarettes will not be deemed a drug unless health claims are made by the vendors. 3 The Commissioner noted that he would respond to ASH's request that the FDA assert jurisdiction over cigarettes as a device in connection with ASH's planned separate petition. 4

Subsequent to the denial of its requests, ASH filed an action in the United States District Court for the District of Columbia on March 1, 1978, challenging the Commissioner's action. On cross-motions for summary judgment, the Honorable John H. Pratt granted defendants' motion and dismissed the case. Action on Smoking and Health (ASH) v. Califano, Civ. No. 78-338 (D.D.C. Jan. 16, 1979), reprinted in J.A. 285-90. Plaintiffs filed a timely appeal.

II. DISCUSSION

A. Standard of Review of the Commissioner's Action

ASH contends that cigarettes containing nicotine fall within the jurisdiction of the FDA as a matter of law under section 201(g)(1) of the Food, Drug, and Cosmetic Act, which states in relevant part as follows: "The term 'drug' means ... (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals ...." 21 U.S.C. § 321(g)(1)(C) (1976). In evaluating the Commissioner's disagreement with this contention, ASH would have this court substitute its judgment for that of the Commissioner, approaching the question of statutory interpretation de novo. We do not believe that such an approach is warranted in this case.

On the contrary, the construction and application of a statute by those charged with its administration is entitled to substantial deference. United States v. Rutherford,

Page 238

442 U.S. 544, 553, 99 S.Ct. 2470, 2476, 61 L.Ed.2d 68 (1979); Udall v. Tallman, 380 U.S. 1, 16, 85 S.Ct. 792, 801, 13 L.Ed.2d 662 (1965). See Federation of Homemakers v. Schmidt, 539 F.2d 740, 743 (D.C.Cir.1976). This court has noted two basic rationales justifying a deferential regard for administrative interpretation of statutes: administrative expertise and congressional acquiescence in the administrative interpretation. Wilderness Society v. Morton, 479 F.2d 842, 866 (D.C.Cir.) (en banc), cert. denied, 411 U.S. 917, 93 S.Ct. 1550, 36 L.Ed.2d 309 (1973). We believe that the latter basis is relevant to the consideration of the administrative interpretation at issue here and agree with the district court, ASH v. Califano, Civ. No. 78-338 (D.D.C. Jan. 16, 1979), memorandum op. at 3, reprinted in J.A. 287, that a deferential approach is mandated. 5 United States v. Rutherford, 442 U.S. 544, 554 n.10, 99 S.Ct. 2470, 2476, 61 L.Ed.2d 68 (1979).

B. Legislative History

The statutory provision in question here has not been modified since its enactment in 1938. Food, Drug, and Cosmetic Act, ch. 675, § 201, 52 Stat. 1040 (1938). Under prior law, the Federal Food and Drug Act of 1906, "drug" had been defined as follows:

all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease in man or other animals.

Federal Food and Drug Act, ch. 3915, 34 Stat. 768 (1906). The limited scope of this definition made it difficult to control such substances as cosmetics, mechanical devices, and fraudulent remedies for obesity. Weitzman, Drug, Device, Cosmetic? Part I, 24 Food Drug Cosm.L.J. 226, 230 n.20 (1969).

Consequently, a legislative effort to secure better protection of the public health began in June of 1933 with the introduction of S. 1944. S.Rep.No.152, 75th Cong., 1st Sess. 2 (1937). Superseding this bill was S. 2800 on which a week of public hearings was held in early 1934. Foods, Drugs, and Cosmetics: Hearings on S. 2800 Before the Senate Comm. on Commerce, 73d Cong., 2d Sess. (1934). These bills contained expanded definitions of drugs. Such expansion, according to W. G. Campbell, Chief of the Food and Drug Administration at that time, would enable the FDA to assert jurisdiction over slenderizing remedies and other harmful products. Id. at 516 (statement of W. G. Campbell). In cases in which FDA jurisdiction was not clearly appropriate, he emphasized, the Administration's jurisdictional analysis would focus upon the existence of representations made by the manufacturer. Thus, as Mr. Campbell explained to one Senator, a chiropractor's table would not be a drug under the Act unless the manufacturer "were to ship that table into interstate commerce, and say that that table would cure various ills." Id. at 517. This concept was further developed in the following exchange between Mr. Campbell and Senator Copeland, the sponsor of the bill:

Senator COPELAND. This is true, too, is it not, Mr. Campbell, that if such devices were shipped without advertising to a legitimate practitioner, and if he chose in his practice, legalized as he is under the law, to use that device, that is his privilege.

Mr. CAMPBELL. Quite right. There is no interference at all with the manufacture, with the marketing, with the use of such product. This is only when someone goes to the extreme of converting that thing into a drug, according to this definition, and making preposterous and ridiculous representations about it that there would be any jurisdiction under this law, and I cannot conceive of that occurrence.

Id. at 518.

These comments reveal the understanding even in 1934 that the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their

Page 239

intent. 6 See also S.Rep.No.361, 74th Cong., 1st Sess. 4 (1935) ("The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put."). Such an understanding has now been accepted as a matter of statutory interpretation. As the Second Circuit has noted, "(t)he vendors' intent in selling the product to the public is the key element in this statutory definition." National Nutritional Foods Association v. Mathews, 557 F.2d 325, 333 (2d Cir. 1977).

C. The Commissioner's Interpretation

Donald Kennedy, Commissioner of Food and Drugs, denied ASH's request that the FDA assert jurisdiction over cigarettes as a drug in a letter memorandum dated December 5, 1977. J.A. 139-42. The Commissioner pointed out initially that FDA jurisdiction could not be predicated upon either evidence of a serious health hazard or the clear absence of authority in any other federal agency to regulate cigarettes. Rather, consistent with the agency's focus upon manufacturers' representations, the FDA has asserted jurisdiction over cigarettes only when health claims were made by the vendors or manufacturers. 7 Absent such claims, the Commissioner stated, cigarettes are not a drug within the meaning of the Act. In answering ASH's contention that cigarettes fall squarely within the statutory definition, the Commissioner stated as follows:

The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are "intended to affect the structure or any function of the body of man..." 21 U.S.C. § 321(g)(1)(C). Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies are not evidence of such intent by the manufacturers or vendors of cigarettes, as required under the provisions of 21 U.S.C. § 321(g)(1)(C) ....

J.A. 142.

Unlike petitioners, we do not read these statements to mean either that the Commissioner will never consider evidence of consumer intent on this question or that he simply ignored the evidence presented to him in this petition. Rather, by failing to introduce...

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    • United States
    • Federal Register January 06, 2000
    • January 6, 2000
    ...must use the product predominantly or nearly exclusively for that purpose. (See, e.g., Action on Smoking and Health (ASH) v. Harris, 655 F.2d 236, 239-240 (D.C. Cir. 1980); National Nutritional Foods (NNFA) v. Weinberger, 512 F.2d 688, 702 (2d Cir. 1975), cert. denied, 423 U.S. 827 (1975).)......
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    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • April 25, 1997
    ...Dkt. No. 77P-0185 at 4-11 (May 26, 1977). FDA rejected ASH's petition and the circuit court upheld FDA's decision. See ASH v. Harris, 655 F.2d 236 (D.C.Cir.1980). One year later, ASH petitioned FDA to regulate cigarettes as "devices," Citizen Petition, Dkt. No. 78P-0338 (Oct. 2, 1978), and ......
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
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    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • August 14, 1998
    ...indicating that the Act did not apply to cigarettes marketed without specific health claims. FDA/Dep't of Justice Brief in ASH v. Harris, 655 F.2d 236 (D.C.Cir.1980), at 16. Again, in 1963, an FDA Bureau of Enforcement Guideline stated that "[t]he statutory basis for the exclusion of tobacc......
  • F.D.A. v Brown & Williamson Tobacco, 981152
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    • United States Supreme Court
    • March 21, 2000
    ...the regulations at issue here. See Brief for Petitioners 37; see also Brief for Appellee (FDA) in Action on Smoking and Health v. Harris, 655 F.2d 236 (CADC 1980), in 9 Rec. in No. 97-1604 (CA4), Tab No. 4, pp. 14-15 ("In the 73 years since the enactment of the original Food and Drug Act, a......
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20 cases
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • April 25, 1997
    ...Dkt. No. 77P-0185 at 4-11 (May 26, 1977). FDA rejected ASH's petition and the circuit court upheld FDA's decision. See ASH v. Harris, 655 F.2d 236 (D.C.Cir.1980). One year later, ASH petitioned FDA to regulate cigarettes as "devices," Citizen Petition, Dkt. No. 78P-0338 (Oct. 2, 1978), and ......
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • August 14, 1998
    ...indicating that the Act did not apply to cigarettes marketed without specific health claims. FDA/Dep't of Justice Brief in ASH v. Harris, 655 F.2d 236 (D.C.Cir.1980), at 16. Again, in 1963, an FDA Bureau of Enforcement Guideline stated that "[t]he statutory basis for the exclusion of tobacc......
  • F.D.A. v Brown & Williamson Tobacco, 981152
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    • United States Supreme Court
    • March 21, 2000
    ...the regulations at issue here. See Brief for Petitioners 37; see also Brief for Appellee (FDA) in Action on Smoking and Health v. Harris, 655 F.2d 236 (CADC 1980), in 9 Rec. in No. 97-1604 (CA4), Tab No. 4, pp. 14-15 ("In the 73 years since the enactment of the original Food and Drug Act, a......
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    • July 23, 2012
    ...its label, accompanying labeling, promotional claims, advertising, and any other relevant source.” Action on Smoking & Health v. Harris, 655 F.2d 236, 239 (D.C.Cir.1980) (internal quotation marks and citations omitted); see21 C.F.R. § 201.128 (“The words intended uses or words of similar im......
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