Flemming v. Florida Citrus Exchange, No. 27

CourtUnited States Supreme Court
Writing for the CourtBRENNAN
Citation358 U.S. 153,3 L.Ed.2d 188,79 S.Ct. 160
PartiesArthur S. FLEMMING, Secretary of Health, Education, and Welfare, Petitioner, v. FLORIDA CITRUS EXCHANGE, Frank R. Schell, et al
Docket NumberNo. 27
Decision Date15 December 1958

358 U.S. 153
79 S.Ct. 160
3 L.Ed.2d 188
Arthur S. FLEMMING, Secretary of Health, Education, and Welfare, Petitioner,

v.

FLORIDA CITRUS EXCHANGE, Frank R. Schell, et al.

No. 27.
Argued Nov. 17, 1958.
Decided Dec. 15, 1958.
Rehearing Denied Jan. 26, 1959.

See 358 U.S. 948, 79 S.Ct. 349.

[Syllabus from pages 153-154 intentionally omitted]

Page 154

Mr. William W. Goodrich, New York City, for petitioner.

Messrs. J. Hardin Peterson, Lakeland, Fla., and J. Lewis Hall, Tallahassee, Fla., for respondents.

Mr. Justice BRENNAN delivered the opinion of the Court.

Commercially grown Florida and Texas oranges have for many years been colored with a red coal-tar color. In 1939

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the Food and Drug Administration, after testing and pursuant to § 406(b) of the Federal Food, Drug, and Cosmetic Act, 1 certified this color, FD&C Red No. 32 (hereafter Red 32), to be harmless and suitable for use in food. However, the Secretary of Health, Education, and Welfare, on November 10, 1955, ordered Red 32 and two other coaltar colors to be removed from the certified list, after new tests in 1951—1953 cast doubt whether Red 32 was harmless, and after public hearings were held upon the matter on notice published in the Federal Register. The consequence of the Secretary's order was that under § 402(c) of the Act2 any food bearing or containing such colors would be deemed to be adulterated.

The validity of the Secretary's order was attacked in petitions under § 701(f) of the Act3 filed in several

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Courts of Appeals4 by persons and organizations claiming to be adversely affected. The Court of Appeals for the Second Circuit sustained the order against a general attack. Certified Color Industry Committee v. Secretary of Health, Education and Welfare, 236 F.2d 866. In the instant case,5 however, the Court of Appeals for the Fifth Circuit, by a divided vote, set aside the order6 insofar as

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it removed the certification of Red 32 as harmless and suitable for use as external coloring on Florida and Texas oranges. 246 F.2d 850.

The Secretary did not determine that Red 32 in the quantities used in color-added oranges was harmful for human consumption, but rather determined on the basis of the 1951—1953 tests only that Red 32 and the other suspect coal-tar colors were toxic and therefore not 'harmless and suitable for use in food.' The Court of Appeals held that the 1939 finding that Red 32 was harmless 'should not be supplanted' by a contrary finding 'unless there is evidence that, in the amounts used, and in the manner of use, oranges colored with Red 32 are unsafe for human consumption.' 246 F.2d at pages 861—862. The word 'harmless' was construed to be a term 'of relation,' preventing the Secretary from denying the continued use of Red 32 in the quantities used in color-added oranges in the absence of evidence that such quantities could not be consumed 'without risk of injury or harm.' Id., at page 858. The Court of Appeals held further that in light of its premise that 'harmless' was a term of relation and because two congressional Committees had found that the practice of adding the color to oranges was an economic necessity, it would be incumbent upon the Secretary to determine whether the use of the color was 'required in the production' of food within the meaning of § 406(a),7

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and if so, promulgate a safe tolerance for Red 32 on oranges pursuant to that section. Until such a tolerance was promulgated, the court held that the Secretary was required to certify Red 32 as a safe color for use on oranges without one. Id., at pages 860 862. We granted certiorari to determine this controversial question of construction of this important statute designed for the protection of the public health. Folsom v. Florida Citrus Exchange, 356 U.S. 911, 78 S.Ct. 669, 2 L.Ed.2d 585.

Senate and House Committees have reported that the practice of adding color is an economic necessity in the production of Florida and Texas oranges for market.8 When mature oranges are removed from the tree, their skins, for botanical reasons unnecessary to detail here, are frequently green in color. Since the consumer would be prone incorrectly to interpret this greenness as a sign of immaturity, oranges are put through a 'degreening' process which involves exposure to ethylene gas. In the case of certain California oranges, this gas process is sufficient to turn a green orange into one of the desired orange color. But the degreening process does not produce the desired color in Florida and Texas oranges; a light yellow shade results. The more desired color is therefore produced by immersing the oranges in, or spraying them with, a solution containing Red 32. The evidence at the hearings held by the Secretary was that the process infuses

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the peel of an orange with 0.0017% to 0.0034% of Red 32. Other evidence indicated that oranges taken as a whole, and candied peel, marmalade and orange juice would contain less—in many cases, much less—of the coal-tar color. It is conceded by the Secretary that there is no evidence that the level of ingestion of Red 32 involved in human consumption of color-added oranges is harmful.

However, the evidence at the Secretary's hearing did indicate that Red 32 had a poisonous effect on animals. Feeding the color to rats in quantities as small as 0.1% of their diet was deleterious and often fatal, with liver damage and enlargement of the heart in evidence. In larger quantities, 1.0% and 2.0% of the diet, ingestion of Red 32 by rats caused death within twelve days and a week, respectively. The health of dogs taking 0.2% of the color in their diets deteriorated rapidly; that of those taking 0.04% somewhat more slowly, but definitely; and ill effects were indicated at a feeding level as low as 0.01% of the diet. No safe level of administration of Red 32 to the test animals was established. These and similar tests, involving the administration of Red 32 and the other coal-tar colors involved to test animals generally as an item of diet, were the basis on which the Secretary's order rested.

The Secretary argues that the legislative history and the consistent administrative interpretation of the Act establish that his authority to list or continue the listing of coal-tar colors is confined to his authority under § 406(b) to certify 'harmless' coal-tar colors, those which are wholly innocuous and demonstrated to be without adverse physiological effect. The argument runs that a toxic coal-tar color, such as the Court of Appeals agreed that Red 32 was, was to be prohibited completely without regard to whether it might possibly be used in safe amounts on a particular food product. The Secretary argues further that since Congress made known its will

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specifically and precisely in § 406(b) that a toxic coal-tar color, that is, one not 'harmless,' was not to be certified under any circumstances, the tolerance provisions of § 406(a) have no relevance to the validity of his order.

We are of the opinion that the Court of Appeals erred and that its judgment cannot stand.

First. The provisions of §§ 402(c) and 406(b) dealing expressly with coal-tar colors were innovations in the Federal Food, Drug, and Cosmetic Act of 1938; there were no counterpart provisions in the original 1906 food and drug legislation. By these provisions, Congress carefully distinguished the treatment to be given by the Secretary to toxic coal-tar colors. The original Act dealt generally with poisonous and other deleterious substances in food, as are now treated under § 402(a), but it did not deal specifically with coal-tar colors. Section 7 of the original Food and Drugs Act, 34 Stat. 769, provided that an article of food should be deemed adulterated 'If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health * * *.' This Court held in United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658, following the 'plain meaning' of the statutory language, that this placed the burden upon the Government of establishing that the added substance was such as might render the food to which it was added injurious to health. This rule applied without distinction where coal-tar colors were involved. Congress was aware of the difficulties of this test which required that the questioned food product be evaluated as a whole, and of the existence in this area of an informal certification practice under the 1906 Act under which not food products but the coal-tar colors themselves were subjected to test to determine their poisonous or harmful character. Cf. S.Rep. No. 361, 74th Cong., 1st Sess., pp. 7—8. Of course, when litigation occurred, the Lexington Mill standard was applied.

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See W.B. Wood Manufacturing Co. v. United States, 7 Cir., 286 F. 84, 86—87.

It was against this background that the 1938 statute was proposed and enacted. It is obvious to us that an approach different from the rule in Lexington Mill was intended by Congress when in § 402(c)9 and § 406(b) it addressed itself to the severable and narrow problem of coal-tar colors. The language involved in Lexington Mill survived generally in the Act's broadest and most general test of food adulteration, § 402(a)(1).10 Section 402(c) provided a separate test: that a food should be deemed adulterated 'If it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 406 * * *.' Plainly Congress banned any addition to foods of coal-tar colors not certified by the Secretary. The standard established for the Secretary was set forth in § 406(b): 'The Secretary shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food and for the certification of batches of such colors * * *.' There appears in Sena-

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27 practice notes
  • Clark v. Valeo, No. 76-1825
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 6 Junio 1977
    ...(parties must show that injury alleged "is more than an abstract possibility at this time"). See also Flemming v. Florida Citrus Exchange, 358 U.S. 153, 167-168, 79 S.Ct. 160, 168-169, 3 L.Ed.2d 188, 196-197 66 Independent Bankers Ass'n v. Smith, supra note 64, 175 U.S.App.D.C. at 190, 534 ......
  • Marrache v. Bacardi U.S.A., Inc., 20-10677
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • 8 Noviembre 2021
    ...years later, in 1938, Congress enacted the FFDCA. Pub. L. No. 75-717, 52 Stat. 1040 (1938); Flemming v. Fla. Citrus Exch. , 358 U.S. 153, 160–61, 79 S.Ct. 160, 3 L.Ed.2d 188 (1958). The FFDCA "was designed primarily to protect consumers from dangerous products," i.e., "to safeguard the cons......
  • Dow Chemical v. Consumer Product Safety Com'n, No. 781166.
    • United States
    • U.S. District Court — Western District of Louisiana
    • 1 Noviembre 1978
    ...the injury need not occur prior to judicial review has been clearly announced in the jurisprudence. E. g., Flemming v. Florida Exchange, 358 U.S. 153, 167-68, 79 S.Ct. 160, 3 L.Ed.2d 188 (1958); Citizens Communications Center v. FCC, 145 U.S.App.D.C. 32, 447 F.2d 1201 (1971); Commonwealth o......
  • Marrache v. Bacardi U.S., Inc., 20-10677
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • 8 Noviembre 2021
    ...Seventy years later, in 1938, Congress enacted the FFDCA. Pub. L. No. 75-717, 52 Stat. 1040 (1938); Flemming v. Fla. Citrus Exch., 358 U.S. 153, 160-61 (1958). The FFDCA "was designed primarily to protect consumers from dangerous products," i.e., "to safeguard the consumer by applying the [......
  • Request a trial to view additional results
27 cases
  • Clark v. Valeo, No. 76-1825
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 6 Junio 1977
    ...(parties must show that injury alleged "is more than an abstract possibility at this time"). See also Flemming v. Florida Citrus Exchange, 358 U.S. 153, 167-168, 79 S.Ct. 160, 168-169, 3 L.Ed.2d 188, 196-197 66 Independent Bankers Ass'n v. Smith, supra note 64, 175 U.S.App.D.C. at 190, 534 ......
  • Marrache v. Bacardi U.S.A., Inc., 20-10677
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • 8 Noviembre 2021
    ...years later, in 1938, Congress enacted the FFDCA. Pub. L. No. 75-717, 52 Stat. 1040 (1938); Flemming v. Fla. Citrus Exch. , 358 U.S. 153, 160–61, 79 S.Ct. 160, 3 L.Ed.2d 188 (1958). The FFDCA "was designed primarily to protect consumers from dangerous products," i.e., "to safeguard the cons......
  • Dow Chemical v. Consumer Product Safety Com'n, No. 781166.
    • United States
    • U.S. District Court — Western District of Louisiana
    • 1 Noviembre 1978
    ...the injury need not occur prior to judicial review has been clearly announced in the jurisprudence. E. g., Flemming v. Florida Exchange, 358 U.S. 153, 167-68, 79 S.Ct. 160, 3 L.Ed.2d 188 (1958); Citizens Communications Center v. FCC, 145 U.S.App.D.C. 32, 447 F.2d 1201 (1971); Commonwealth o......
  • Marrache v. Bacardi U.S., Inc., 20-10677
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • 8 Noviembre 2021
    ...Seventy years later, in 1938, Congress enacted the FFDCA. Pub. L. No. 75-717, 52 Stat. 1040 (1938); Flemming v. Fla. Citrus Exch., 358 U.S. 153, 160-61 (1958). The FFDCA "was designed primarily to protect consumers from dangerous products," i.e., "to safeguard the consumer by applying the [......
  • Request a trial to view additional results

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