Dietary Supplement Coalition, Inc. v. Sullivan

• Decision Date: 11 July 1991
• Docket Number: Civ. No. 91-126-RE.
• Citation: 796 F. Supp. 441
• Parties: DIETARY SUPPLEMENT COALITION, INC., et al., Plaintiffs, v. Louis W. SULLIVAN, M.D., Secretary of Health and Human Services, David A. Kessler, M.D., Commissioner of Food and Drugs, and Food and Drug Administration, Defendants.
• Court: U.S. District Court — District of Oregon

796 F. Supp. 441

DIETARY SUPPLEMENT COALITION, INC., et al., Plaintiffs, v. Louis W. SULLIVAN, M.D., Secretary of Health and Human Services, David A. Kessler, M.D., Commissioner of Food and Drugs, and Food and Drug Administration, Defendants.

Civ. No. 91-126-RE.

United States District Court, D. Oregon.

July 11, 1991.

Richard Botteri, Weiss, Jensen, Ellis & Botteri, Portland, Or., I. Scott Bass, Robert A. Sellers, Jr., Bass & Ullman, New York City, for plaintiffs.

Charles H. Turner, U.S. Atty., D. Or., Judith D. Kobbervig, Asst. U.S. Atty., Portland, Or., Darya Geetter, Atty., Office of Consumer Litigation, U.S. Dept. of Justice, Washington, D.C., for defendants.

OPINION

REDDEN, Chief Judge.

BACKGROUND

Plaintiffs filed this action for a declaratory judgment that their products which contain Co-enzyme Q10 (CoQ10) are "foods" and not "food additives," or, are "generally recognized as safe" within the meaning of the Food and Drug Act, 21 U.S.C. § 301 (the Act). Such a determination would exempt plaintiffs' products from premarket review by the Food and Drug Administration (FDA). Defendants filed a motion to dismiss alleging that since the FDA has not made a final determination regarding plaintiffs' CoQ10 products, there is no controversy for the court to decide, and plaintiffs' claim is not ripe for review. Further, defendants allege that plaintiffs have failed to exhaust their administrative remedies.

Plaintiff Dietary Supplement Coalition, Inc., is an incorporated trade association of "food and dietary supplement" manufacturers, whose purpose is to redress the FDA's alleged "improper attempts to eliminate safe dietary supplements from the market." Plaintiff Health Haus is a corporation that distributes products including those containing the ingredient CoQ10. Some of the member companies of plaintiff Dietary Supplement Coalition have also engaged in distributing CoQ10.

In 1989, the FDA initiated two proceedings to seize bottles of CoQ10 from Natural Organics, Inc., and Bio-Energy Nutrient, Inc.; member companies of plaintiff Dietary Supplement Coalition. The FDA stated that under the provisions of the Act, CoQ10 is an unsafe food additive because there is no FDA regulation prescribing the conditions under which it may be safely used. The FDA also issued regulatory letters concerning CoQ10 informing recipients that CoQ10 is an unapproved food additive whose continued marketing subjects it and its sellers to enforcement action.

I grant defendants' motion to dismiss and dismiss this action.

STANDARDS

Under Fed.R.Civ.P. 12(b)(6), dismissal for failure to state a claim is proper only when it appears to a certainty that the plaintiffs can prove no set of facts in support of their claim that would entitle them to relief. Litchfield v. Spielberg, 736 F.2d 1352, 1357 (9th Cir.1984), cert. denied, 470 U.S. 1052, 105 S.Ct. 1753, 84 L.Ed.2d 817 (1985). For the purpose of a motion to dismiss, the complaint is liberally construed in favor of the plaintiffs, and its allegations are taken as true. Rosen v. Walters, 719 F.2d 1422, 1424 (9th Cir.1983).

DISCUSSION

1. Ripeness

In deciding whether an issue is ripe for review, the courts must evaluate "both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Abbott Laboratories v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 1515, 18 L.Ed.2d 681 (1967).

A. ISSUES FIT FOR JUDICIAL RESOLUTION

(1) Food vs. Food Additive

A claim is fit for decision if the issues raised are purely legal and do not require further factual development, and the challenged action is final. Abbott Laboratories, 387 U.S. at 149, 87 S.Ct. at 1515-16. I find that plaintiffs' claims do not raise purely legal questions. Plaintiffs allege that CoQ10 is "normally sold in a capsule form without other nutrients," and that it "has enormous benefits for health by providing a rich source of nutrients...." Those allegations do not give this court a legal basis to determine that CoQ10 is a "food" and not a "food additive" within the meaning of the Act. The Ninth Circuit held:

classification of a product as a ... food involves the same complex chemical and pharmacological considerations, and determination of technical and scientific questions, that led the Supreme Court to conclude that new drug decisions are best left to agency expertise. We therefore conclude that it is appropriate for a district court to decline reviewing anything less than a final administrative determination on the classification of a product....

Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1377 (9th Cir.1983). I also rely on Estee Lauder, Inc. v. FDA, 727 F.Supp. 1, 4-5 (D.D.C.1989), where plaintiff sought a legal determination that its cosmetic products were not misbranded drugs under the Act. The court granted defendant's motion to dismiss holding:

ripeness and finality considerations prevent this court from declaring that the FDA's position is unreasonable, arbitrary, and capricious. First the issue of whether Lauder's skin creams are improperly making drug-like claims is not purely a legal question.... This court would also have to make a fact-based determination as to the "intended use" of each of the Lauder products. Such a factual review would deny the FDA the full opportunity to apply its expertise and to correct errors or modify positions in the course of a proceeding.... These considerations weigh strongly in favor of dismissal when the court is asked to rule on a factual question, particularly within the agency's bailiwick as opposed to a purely legal question within the primary competence of the courts.

Id. at 4 (citations omitted).

Therefore, determining whether plaintiffs' CoQ10 products are "foods," rather than "food additives," is not a purely legal question, and therefore is not an issue ripe for this court.

Plaintiffs respond that the determination is purely a legal one and "turns entirely on a reading of the legislative history behind the Act as well as an analysis of the relevant case law and a determination of whether a CoQ10 capsule can truthfully be classified as a substance used to flavor, stabilize or sterilize food." Plaintiffs' Memo in Opposition, p. 13.

Plaintiffs contend that Estee Lauder can be distinguished because the court there found that judicial review would have interrupted an "ongoing" agency decision-making process that involved merely a "tentative" agency position. Id. at 4-5. However, the court also held that the issue of whether Lauder's skin creams are improperly making drug-like claims was not a purely legal question. The court found it would be necessary to engage in an extensive fact-based determination in order to resolve the dispute. "Such a factual review would deny the Administration the full opportunity to apply its expertise and to correct errors or modify positions in the course of a proceeding." Id. at 4. The court held that these considerations "weigh strongly in favor of dismissal when the court is asked to rule on a factual question particularly within the agency's bailiwick as opposed to a purely legal question within the primary competence of the courts." Id.

Plaintiffs here also argue that the Biotics case "rested its entire decision" on the finding that the agency was not committed to an enforcement action. Plaintiffs' Memo in Opposition, p. 15. However, Biotics did not address the existence of any factual dispute regarding the classification of a product by the FDA. Biotics focused only on whether there had been final agency action, and after concluding there had not been, did not reach the issue of whether the FDA had properly classified the product.

Here, defendants contend that a factual issue exists as to the proper classification of the food or food additive that should not be resolved by the courts. I agree that a factual issue does exist as to whether plaintiffs' product is properly classified as a food or food additive and that that issue is properly resolved by the agency, not the courts. As in Estee Lauder, this court would be put in the position of having to make a factual determination in an area where the FDA holds the expertise and the courts do not. In the cases relied on by plaintiffs, the courts state that the parties agree that there is no factual dispute about whether the proposed classification or rule is purely a legal question. Here, there is clearly a dispute by defendants, who argue that the classification is not a legal question, but one of factual determination.

(2) Issue Ripe for Judicial Review

Defendants also argue that this issue is not fit for judicial decision because there has been no final agency action. "In interpreting the finality requirement, a court looks to whether the agency action represents the final administrative work to insure that judicial review will not interfere with the agency's decision-making process." Winter v. Cal. Medical Review, 900 F.2d 1322, 1324-25 (9th Cir.1990). Defendants assert that the FDA's actions to enforce the Act, the issuance of regulatory letters and the two seizures of CoQ10, do not constitute final agency action. See Biotics, 710 F.2d at 1377 ("the 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...."); and Estee Lauder, 727 F.Supp. at 4-5 ("by its very nature the FDA regulatory letter was informal and advisory," and did not constitute final agency action).

Defendants assert that the seizures also do not represent final agency action. Schering v. Heckler, 779 F.2d 683 (D.C.Cir. 1985). In Schering, the FDA instituted a seizure action against a new animal drug (for chicks), secured a default judgment, and destroyed a quantity of the new drug. The court held that these actions "do not constitute final agency action...." Id. at 686 n. 18.

Plaintiffs argue that seizure by the FDA does constitute final agency action making the issue...