Dietary Supplemental Coalition, Inc. v. Sullivan, No. 91-36013

CourtUnited States Courts of Appeals. United States Court of Appeals (9th Circuit)
Writing for the CourtBEEZER
PartiesDIETARY SUPPLEMENTAL COALITION, INC.; the Health Haus, Inc., Plaintiffs-Appellants, v. Louis W. SULLIVAN, M.D.; David A. Kessler, Commissioner of Food and Drug Administration, Defendants-Appellees.
Docket NumberNo. 91-36013
Decision Date05 November 1992

Page 560

978 F.2d 560
DIETARY SUPPLEMENTAL COALITION, INC.; the Health Haus,
Inc., Plaintiffs-Appellants,
v.
Louis W. SULLIVAN, M.D.; David A. Kessler, Commissioner of
Food and Drug Administration, Defendants-Appellees.
No. 91-36013.
United States Court of Appeals,
Ninth Circuit.
Argued and Submitted Sept. 18, 1992.
Decided Nov. 5, 1992.

Page 561

I. Scott Bass, Piper & Marbury, New York City, for plaintiffs-appellants.

Heidi A. Garland, U.S. Dept. of Justice, Civ. Div., Jeffrey B. Chasnow, Office of Consumer Litigation, Washington, D.C., for defendants-appellees.

Page 562

Appeal from the United States District Court for the District of Oregon.

Before: BEEZER, NOONAN, and TROTT, Circuit Judges.

BEEZER, Circuit Judge:

We consider whether the Food and Drug Administration's classification of dietary supplement Co-enzyme Q10 ("CoQ10") is an issue ripe for judicial review. The district court dismissed plaintiff's action for declaratory judgment on the grounds that 1) the issue raised was not purely legal; 2) the challenged action was not final; and 3) the plaintiffs had not exhausted their administrative remedies, 796 F.Supp. 441. Plaintiffs timely appeal. We affirm.

I

Plaintiffs-appellants are a coalition of dietary supplement manufacturers, known as the Dietary Supplement Coalition, and an Oregon dietary supplement distributor called the Health Haus, Inc. (referred to collectively as "DSC").

In 1989, the Food and Drug Administration ("FDA") initiated two proceedings to seize bottles of CoQ10 from Natural Organics, Inc., and Bio-Energy Nutrient, Inc., both member companies of DSC. The FDA stated that under the provisions of the Food and Drug Act, 21 U.S.C. § 321(s) (1988), CoQ10 was an unsafe food additive because no FDA regulation prescribed the conditions under which it could be safely used. The FDA also issued regulatory letters concerning CoQ10 informing recipients that CoQ10 was an unapproved food additive whose continued marketing subjected its sellers to enforcement actions.

DSC filed an action in district court for declaratory judgment. DSC claims that their products which contain CoQ10 are "foods" and not "food additives," or are "generally recognized as safe" within the meaning of the Food and Drug Act.

The district court granted the government's motion to dismiss, holding that the issues presented were not ripe for judicial review. DSC appeals, claiming that despite the lack of a formal pronouncement on the general status of CoQ10, the FDA has made a decision regarding the product's classification that is sufficiently final for the purpose of judicial review.

II

A ruling on subject matter jurisdiction is a question of law subject to de novo review. Winter v. Calif. Medical Review, Inc., 900 F.2d 1322, 1324 (9th Cir.1990). In determining ripeness issues, we evaluate "both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Id. at 1325; see also Abbott Lab. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 1515-16, 18 L.Ed.2d 681 (1967). The fitness element requires that the issue be primarily legal, need no further factual development, and involve a final agency action. Winter, 900 F.2d at 1325. To meet the hardship requirement, a party must show that withholding judicial review would result in direct and immediate hardship and would entail more than possible financial loss. Id.

DSC says that the FDA has made a final determination regarding the classification of CoQ10. We first consider the element of the ripeness inquiry requiring "final agency action."

In interpreting the finality requirement, we look to whether the agency action represents the final administrative work. This requirement insures judicial review will not interfere with the agency's decision-making process. Winter, 900 F.2d at 1324-25. The finality element must be interpreted in a "pragmatic" and "flexible" manner. Abbott Lab., 387 U.S. at 149-50, 87 S.Ct. at 1516.

In support of its argument that the FDA has taken final administrative action, DSC points to the seizure actions, the FDA regulatory letters, and the testimony of an FDA expert in a separate case. Because the expert testimony was not before the district court, it is not a part of the record on appeal. See Kirshner v. Uniden Corp. of America, 842 F.2d 1074, 1077 (9th Cir.1988);

Page 563

Fed.R.App.P. 10(a); Ninth Cir.R. 10-2.

We have held that regulatory letters do not constitute final agency action. See Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1377 (9th Cir.1983) (" '[T]he type of informal letter issued by the FDA ... does not constitute the kind of formal or final agency action the Supreme Court had in mind....' ") (quoting IMS Ltd. v. Califano, 453 F.Supp. 157, 160 (C.D.Cal.1977)); see also Estee Lauder, Inc. v. United States Food and Drug Admin., 727 F.Supp. 1, 5 (D.D.C.1989) (FDA regulatory letter was "informal and advisory" and...

To continue reading

Request your trial
34 practice notes
  • Exela Pharma Scis., LLC v. Sandoz, Inc., CIVIL CASE NO. 1:19-cv-00318-MR
    • United States
    • United States District Courts. 4th Circuit. Western District of North Carolina
    • September 15, 2020
    ...No. 07-CV-642, 2009 WL 151573 (E.D. Wis. Jan. 22, 2009) (collecting cases); see also Dietary Supplemental Coal., Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir. 1992) (stating that "regulatory letters do not constitute final agency action."). Indeed, the FDA later explained to the Plaintiff t......
  • Lacey v. C.S.P. Solano Medical Staff, No. Civ S-96-1452 LKK DAD P.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • December 22, 1997
    ...the decision rendered in the administrative proceedings created by the statute itself); Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 564 (9th Cir.1992), cert. denied sub nom. Dietary Supplement Coalition, Inc. v. Shalala, 508 U.S. 906, 113 S.Ct. 2333, 124 L.Ed.2d 245 Cali......
  • Summit Tech. v. High-Line Med. Instruments Co., No. CV 95-6491 ABC (SHx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • July 16, 1996
    ...letters do not constitute final agency action. Summit, 922 F.Supp. at 306 (citing Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir.1992), cert. denied, 508 U.S. 906, 113 S.Ct. 2333, 124 L.Ed.2d 245 (1993)). "Indeed, after further review, the FDA could ultimately ......
  • Oregon Natural Desert Ass'n v. U.S. Forest Service, No. 05-35637.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • September 21, 2006
    ...manner.'" Or. Natural Res. Council v. Harrell, 52 F.3d 1499, 1504 (9th Cir.1995) (quoting Dietary Supplemental Coal., Inc. v. Sullivan, 978 F.2d 560 (9th Cir.1992)); Cal. Dep't of Educ. v. Bennett, 833 F.2d 827, 833 (9th Cir.1987) ("The requirement of finality is interpreted The Forest Serv......
  • Request a trial to view additional results
34 cases
  • Exela Pharma Scis., LLC v. Sandoz, Inc., CIVIL CASE NO. 1:19-cv-00318-MR
    • United States
    • United States District Courts. 4th Circuit. Western District of North Carolina
    • September 15, 2020
    ...No. 07-CV-642, 2009 WL 151573 (E.D. Wis. Jan. 22, 2009) (collecting cases); see also Dietary Supplemental Coal., Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir. 1992) (stating that "regulatory letters do not constitute final agency action."). Indeed, the FDA later explained to the Plaintiff t......
  • Lacey v. C.S.P. Solano Medical Staff, No. Civ S-96-1452 LKK DAD P.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • December 22, 1997
    ...the decision rendered in the administrative proceedings created by the statute itself); Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 564 (9th Cir.1992), cert. denied sub nom. Dietary Supplement Coalition, Inc. v. Shalala, 508 U.S. 906, 113 S.Ct. 2333, 124 L.Ed.2d 245 Cali......
  • Summit Tech. v. High-Line Med. Instruments Co., No. CV 95-6491 ABC (SHx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • July 16, 1996
    ...letters do not constitute final agency action. Summit, 922 F.Supp. at 306 (citing Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir.1992), cert. denied, 508 U.S. 906, 113 S.Ct. 2333, 124 L.Ed.2d 245 (1993)). "Indeed, after further review, the FDA could ultimately ......
  • Oregon Natural Desert Ass'n v. U.S. Forest Service, No. 05-35637.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • September 21, 2006
    ...manner.'" Or. Natural Res. Council v. Harrell, 52 F.3d 1499, 1504 (9th Cir.1995) (quoting Dietary Supplemental Coal., Inc. v. Sullivan, 978 F.2d 560 (9th Cir.1992)); Cal. Dep't of Educ. v. Bennett, 833 F.2d 827, 833 (9th Cir.1987) ("The requirement of finality is interpreted The Forest Serv......
  • Request a trial to view additional results

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT