Independent Cosmetic Manufacturers & Distributors, Inc. v. U.S. Dept. of Health, Ed. and Welfare, Nos. 75-1845

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtBefore ROBB and WILKEY; ROBB; WILKEY
Citation187 U.S.App.D.C. 342,574 F.2d 553
Decision Date11 April 1978
Docket Number76-1007,Nos. 75-1845
PartiesINDEPENDENT COSMETIC MANUFACTURERS AND DISTRIBUTORS, INC., Petitioner, v. UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, United States Food and Drug Administration and Donald Kennedy, Commissioner of Food and Drug Administration, Respondents. INDEPENDENT COSMETIC MANUFACTURERS AND DISTRIBUTORS, INC., Appellant, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education and Welfare, et al.

Page 553

574 F.2d 553
187 U.S.App.D.C. 342
INDEPENDENT COSMETIC MANUFACTURERS AND DISTRIBUTORS, INC., Petitioner,
v.
UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE,
United States Food and Drug Administration and Donald
Kennedy, Commissioner of Food and Drug
Administration, Respondents.
INDEPENDENT COSMETIC MANUFACTURERS AND DISTRIBUTORS, INC., Appellant,
v.
Joseph A. CALIFANO, Jr., Secretary of Health, Education and
Welfare, et al.
Nos. 75-1845, 76-1007.
United States Court of Appeals,
District of Columbia Circuit.
Argued Dec. 14, 1976.
Decided Feb. 13, 1978.
Rehearing Denied April 11, 1978.

Walter E. Byerley, Washington, D.C., for petitioner-appellant.

John R. Fleder, Atty., Dept. of Justice, Washington, D.C., with whom Charles R. McConachie, Chief, Consumer Affairs Section and Robert V. Allen, Atty., Dept. of Justice, Washington, D.C., were on the brief for respondent-appellee, Health, Education and Welfare.

Donald O. Beers, U. S. Food and Drug Administration, Rockville, Md., with whom Richard A. Merrill, Chief Counsel, U. S. Food and Drug Administration, Rockville, Md., were on the brief for respondent Food and Drug Administration.

Before ROBB and WILKEY, Circuit Judges, and GESELL, * United States District Judge for the United States District Court for the District of Columbia.

Opinion for the court filed by Circuit Judge ROBB.

Dissenting opinion filed by Circuit Judge WILKEY.

ROBB, Circuit Judge:

Independent Cosmetic Manufacturers and Distributors, Incorporated (ICMAD) challenges a regulation promulgated by the Food and Drug Administration. The regulation requires that all packaged cosmetics be identified by labels listing their ingredients. ICMAD challenged the regulation on two fronts. First, ICMAD sought declaratory and injunctive relief in the District Court. The District Court dismissed the suit for want of jurisdiction and ICMAD appeals. ICMAD's second front is a petition in this court for direct review of the regulation.

We affirm the District Court's holding that it lacked jurisdiction, for jurisdiction lies exclusively in the court of appeals. In exercising our jurisdiction, however, we decline to set aside the regulation. We turn first to the jurisdictional issue.

JURISDICTION OF THE DISTRICT COURT

The regulation may be challenged by petition to an appropriate United States Court of Appeals. 15 U.S.C. § 1455(a); 21 U.S.C. § 371(f). The statute does not specify whether district courts may exercise concurrent jurisdiction when an independent source of jurisdiction can be found. ICMAD asserts, however, that the trial court had concurrent jurisdiction by virtue of a savings clause in the statute, 21 U.S.C. § 371(f)(6). That clause provides:

The remedies provided for in this subsection (review in the court of appeals) shall be in addition to and not in substitution for any other remedies provided by law.

We think jurisdiction in this case is governed by our decision in Nader v. Volpe, 151 U.S.App.D.C. 90, 466 F.2d 261 (1972). In that case we considered a similar review provision of the National Traffic Motor Vehicle Safety Act, with an almost identical savings clause. See 15 U.S.C. § 1394(a). We concluded that when Congress has specified a procedure for judicial review of administrative action, that procedure is the exclusive means of review unless, because of some extraordinary circumstances, the procedure fails to provide an adequate remedy. 151 U.S.App.D.C. at 100, 466 F.2d at 271. Those extraordinary circumstances, we noted, were "instances of agency action which is ultra vires or damaging beyond the capability of the statutory procedure to repair." Id.

Page 555

Although ICMAD contends that the Commissioner's action in this case is ultra vires, we disagree. As our opinion in Nader v. Volpe makes clear, a party urging jurisdiction based on ultra vires action must show a patent violation of agency authority. Compare 151 U.S.App.D.C. at 100 & n. 66, 466 F.2d at 271 & n. 66, with 151 U.S.App.D.C. at 95 & n. 30, 466 F.2d at 266 & n. 30. ICMAD argues that the agency disregarded 21 U.S.C. § 371(e)(3) in failing to hold a hearing "as soon as practicable" after objections were filed regarding certain parts of the regulation promulgated on October 17, 1973. The objections none of which came from ICMAD asserted that exemptions to labeling and alternative means of compliance should be permitted. Instead of immediately convening a hearing the Commissioner began negotiations with the objectors. This informal procedure was, at least in part, invited by the objectors. 1 The negotiations resulted in the amendment of the regulation on March 3, 1975 (40 Fed.Reg. 8918), after which the objections were withdrawn and the need for a hearing obviated. 40 Fed.Reg. 23460 (1975). We need not determine whether upon closer scrutiny this informal procedure fully comported with the statute; it is sufficient that we decide that in these circumstances the failure to hold a hearing was not a patent violation of agency authority. Nor are any of the lesser irregularities alleged by ICMAD so patently defective as to warrant district court jurisdiction.

Our conclusion is consistent with settled principles of law 2 and the legislative history of the Food and Drug Act. 3 ICMAD contends, however, that the legislative history as set out in Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), is contrary to our conclusion and that the Court's holding there controls this case. We disagree. The Supreme Court in the Abbott Laboratories case noted that Congress intended in enacting the savings clause to preserve, not concurrent jurisdiction, but equitable remedies available when no adequate remedy at law exists. See id. at 142-43, 87 S.Ct. 1507. The Supreme Court did uphold district court jurisdiction in that case, for no special statutory review provisions applied to the challenged regulations, id. at 141, 87 S.Ct. 1507, and hence there was no adequate remedy at law. Nader v. Volpe, 151 U.S.App.D.C. at 100 n. 68, 466 F.2d at 271 n. 68 (distinguishing Abbott Laboratories v. Gardner on this basis). Indeed, the Supreme Court said in the Abbott Laboratories opinion, "when the special provisions (for review) apply, presumably they must

Page 556

be used and a court would not grant injunctive or declaratory judgment relief unless the appropriate administrative procedure is exhausted." Id. at 146, 87 S.Ct. at 1514; see Katzenbach v. McClung, 379 U.S. 294, 296, 85 S.Ct. 377, 13 L.Ed.2d 290 (1964). Here those special procedures for review do apply and as we noted in Nader v. Volpe:

The District Court had but limited jurisdiction of the case at the outset for the purpose of taking a peek to see whether it had jurisdiction of the subject matter by virtue of exceptional circumstances. When it found no such circumstances it rightly dismissed the action for lack of subject-matter jurisdiction.

151 U.S.App.D.C. at 101, 466 F.2d at 272.

That exclusive jurisdiction lies in the courts of appeals is further demonstrated by the scheme of the Act. Finding concurrent jurisdiction under some general jurisdictional mandate, such as federal question jurisdiction, would permit ICMAD to bypass the 90-day time limit that Congress imposed on petitions to review challenged regulations. See 21 U.S.C. § 371(f)(1). That is precisely what ICMAD seeks to do here; for as we demonstrate later, a major portion of ICMAD's petition for direct review in this court is untimely. 4

PETITION FOR REVIEW

In its petition to this court ICMAD challenges the Commissioner's regulation in two respects. First, on several different theories ICMAD argues that the substance of the original regulation contravenes the Fair Packaging and Labeling Act (F.P.L.A.).

Page 557

See Petitioner's Brief in 75-1845 at p. 3. Second, ICMAD contends that the procedure followed by the Commissioner in promulgating amendments to the regulation was deficient. Id. Because ICMAD's challenge to the original regulation is untimely and because ICMAD has not been prejudiced by the procedure followed in adopting the amendments, we deny its petition.

ICMAD argues that the cosmetic ingredient labeling regulation violates the F.P.L.A. because: section 1454 of the Act mandates that the Commissioner promulgate labeling regulations on a commodity-by-commodity, not a cosmetic-wide, basis; that the Commissioner, contrary to section 1454(c), made no determination that the regulation was necessary to prevent deception and to facilitate comparisons; 5 that contrary to section 1454(c)(3) the regulation requires divulgence of trade secrets; and that while section 1454(c) (3) requires labeling of only certain ingredients, the regulation requires labeling of all ingredients. See Petitioner's Brief at 13-23.

ICMAD's attack challenges the original regulation, which was published in final form in the Federal Register on October 17, 1973 (38 Fed.Reg. 28912). 6 Section 371(f)(1)

Page 558

of the Food and Drug Act requires that petitions for review of an FDA order be filed within 90 days from the date the order issues, and ICMAD's petition for review in 1975 clearly falls outside that 90-day boundary. Nor can ICMAD's challenge be deemed timely filed as an attack on the amendments promulgated in 1975. The amendments merely provided narrow exemptions to labeling and alternate means of compliance applicable in limited circumstances. 7 A comparison of the original regulation and the amendments makes clear that the amendments did not change the substance or thrust of the original regulation. See 40 Fed.Reg. 8918-24 (1975); note 6, supra. The attack on the original regulation is therefore untimely.

ICMAD's procedural attack must also fail. ICMAD urges that because of alleged irregularities in amending the regulation, it was foreclosed from challenging the basic regulation. We believe however that if any irregularity occurred, ICMAD was not prejudiced thereby and hence no...

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30 practice notes
  • Environmental Defense Fund, Inc. v. Gorsuch, Nos. 81-2025
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • July 26, 1983
    ...Court and Court of Appeals over identical litigation is not favored." Id. at 660. See also Ind. Cosmetic Mfr. v. U.S. Dept. of H.E.W., 574 F.2d 553, 555 n. 2 (D.C.Cir.1978). We similarly conclude with respect to the matter of jurisdiction that EDF's present claim falls within this court's e......
  • CONSORTIUM OF COM. BASED ORGANIZATIONS v. Donovan, Civ. No. S-81-135 LKK.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 11, 1982
    ...617 F.2d 611, 621 (D.C.Cir.1979); Independent Cosmetic Mfgs. & Distributors, Inc. v. United States Dept. of Health, Education & Welfare, 574 F.2d 553, 554 (D.C.Cir.1978), cert. denied, 439 U.S. 893, 99 S.Ct. 250, 58 L.Ed.2d 238 (1978).href="#fn14" name="14">14 This conclusion makes it unnec......
  • N. Am. Butterfly Ass'n v. Wolf, No. 19-5052
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • October 13, 2020
    ...authority.’ " Am. Clinical , 931 F.3d at 1208 (quoting Indep. Cosmetic Mfrs. & Distribs., Inc. v. U.S. Dep't of Health, Educ. & Welfare , 574 F.2d 553, 555 (D.C. Cir. 1978) ). Second, it argues that the funding restrictions in the 2019 and 2020 Appropriations Acts render the Waiver Determin......
  • City of Rochester v. Bond, No. 78-1352
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • May 25, 1979
    ...Congress that district court jurisdiction be preserved under certain circumstances. See Indep. Cosmetic Mfrs. v. U. S. Dept. of HEW, 187 U.S.App.D.C. 342, 361-362, 574 F.2d 553, 571-73, Cert. denied, 439 U.S. 893, 99 S.Ct. 250, 58 L.Ed.2d 238 (1978) (Wilkey, J., dissenting) (saving clause p......
  • Request a trial to view additional results
29 cases
  • Environmental Defense Fund, Inc. v. Gorsuch, Nos. 81-2025
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • July 26, 1983
    ...Court and Court of Appeals over identical litigation is not favored." Id. at 660. See also Ind. Cosmetic Mfr. v. U.S. Dept. of H.E.W., 574 F.2d 553, 555 n. 2 (D.C.Cir.1978). We similarly conclude with respect to the matter of jurisdiction that EDF's present claim falls within this court's e......
  • CONSORTIUM OF COM. BASED ORGANIZATIONS v. Donovan, Civ. No. S-81-135 LKK.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 11, 1982
    ...617 F.2d 611, 621 (D.C.Cir.1979); Independent Cosmetic Mfgs. & Distributors, Inc. v. United States Dept. of Health, Education & Welfare, 574 F.2d 553, 554 (D.C.Cir.1978), cert. denied, 439 U.S. 893, 99 S.Ct. 250, 58 L.Ed.2d 238 (1978).href="#fn14" name="14">14 This conclusion makes it unnec......
  • N. Am. Butterfly Ass'n v. Wolf, No. 19-5052
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • October 13, 2020
    ...authority.’ " Am. Clinical , 931 F.3d at 1208 (quoting Indep. Cosmetic Mfrs. & Distribs., Inc. v. U.S. Dep't of Health, Educ. & Welfare , 574 F.2d 553, 555 (D.C. Cir. 1978) ). Second, it argues that the funding restrictions in the 2019 and 2020 Appropriations Acts render the Waiver Determin......
  • City of Rochester v. Bond, No. 78-1352
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • May 25, 1979
    ...Congress that district court jurisdiction be preserved under certain circumstances. See Indep. Cosmetic Mfrs. v. U. S. Dept. of HEW, 187 U.S.App.D.C. 342, 361-362, 574 F.2d 553, 571-73, Cert. denied, 439 U.S. 893, 99 S.Ct. 250, 58 L.Ed.2d 238 (1978) (Wilkey, J., dissenting) (saving clause p......
  • Request a trial to view additional results

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