Kellogg Co. v. Mattox

• Citation: 763 F. Supp. 1369
• Decision Date: 12 April 1991
• Docket Number: Civ. A. CA 3-90-2005-G.
• Parties: KELLOGG COMPANY, Plaintiff, v. Jim MATTOX, Attorney General of the State of Texas, et al., Defendants.
• Court: U.S. District Court — Northern District of Texas

763 F. Supp. 1369

KELLOGG COMPANY, Plaintiff, v. Jim MATTOX, Attorney General of the State of Texas, et al., Defendants.^*

Civ. A. CA 3-90-2005-G.

United States District Court, N.D. Texas, Dallas Division.

April 3, 1991.

As Amended April 12, 1991.

COPYRIGHT MATERIAL OMITTED

Terrell Wallace Oxford, Susman & Godfrey, Dallas, Tex., Frederick P. Furth, Daniel S. Mason, Bruce J. Wecker, Michael P. Lehmann, George F. Bishop, and Scott R. Campbell, Furth Fahrner & Mason, San Francisco, Cal., for plaintiff.

Joselle Marie Albracht, Stephen Henry Gardner, and Craig A. Jordan, Atty. Gen. of Texas, Dallas, Tex., and Dan Morales, Texas Atty. Gen., Austin, Tex., for defendants.

MEMORANDUM ORDER

FISH, District Judge.

This case is before the court on the motion of plaintiff Kellogg Company ("Kellogg") for a preliminary injunction. For the reasons stated below, the motion is denied.

FINDINGS OF FACT

I. Nature and Status of Suit

1. This suit was filed by Kellogg against Texas Attorney General Jim Mattox and Commissioner Robert Bernstein of the Texas Department of Health ("TDH") (collectively, the defendants will be referred to as "the State" or "Texas"). Kellogg's complaint alleges claims for injunctive and declaratory relief under the Commerce Clause of the United States Constitution (U.S. Const., Art. I, § 8); the Supremacy Clause of the Constitution (id., Art. VI, cl. 2), based on preemption by the Federal Food, Drug and Cosmetic Act ("FDCA") (21 U.S.C. § 301 et seq.); violation of the First Amendment; and violation of the Equal Protection Clause of the Fourteenth Amendment. Kellogg also seeks a declaration, pursuant to the Federal Declaratory Judgment Act (28 U.S.C. § 2201 et seq.), that its ready-to-eat ("RTE") cereal Heartwise is not being marketed in violation of the Texas Food, Drug, and Cosmetic Act ("Texas Act").

2. Kellogg's complaint was filed on August 30, 1990. On various dates in September, 1990, as will be explained below, TDH detained packages of Heartwise at warehouse locations in Texas. Kellogg responded by filing an application for a temporary restraining order, which was denied on September 7, 1990.

II. The Parties

3. Kellogg, a Delaware corporation, maintains its principal place of business at Battle Creek, Michigan. Its activities include the manufacture and sale of RTE breakfast cereals, including Heartwise.

4. Defendant Jim Mattox was the attorney general of Texas when this suit was filed. He has been succeeded in that office by Dan Morales.

5. Defendant Robert Bernstein is the Commissioner of TDH.

III. Analysis of the Evidence

A. The Introduction of Heartwise Cereal

6. Beginning on August 31, 1989, Kellogg introduced Heartwise cereal to the nationwide market. Affidavit of John R. Aubuchon ("Aubuchon aff.") ¶ 7.

7. Heartwise is an RTE cereal. It contains less than 3 grams of psyllium per serving. Deposition of Victor Fulgoni ("Fulgoni dep.") 34:13-35:5. Psyllium is a grain grown primarily in India. Psyllium is also the primary ingredient in various bulk-forming laxatives, including Metamucil and Fiberall. Affidavit of Victor Fulgoni ("Fulgoni aff.") ¶ 6.

8. Heartwise cereal is distributed and sold in the same manner as other RTE cereals manufactured and distributed by Kellogg. It is manufactured in the same facilities as other RTE cereals manufactured by Kellogg, and is shipped along with other RTE cereals to retail grocers and others. Heartwise cereal is displayed in retail grocery stores in the same section of the stores and alongside other Kellogg RTE cereals. The sale of Heartwise cereal in Texas and the advertising relating to that product are part of a national sales program. Aubuchon aff. ¶¶ 13-14.

9. According to Kellogg, it intended from the outset that Heartwise cereal would be sold and advertised exclusively as a food, not a drug, product. The State, on the other hand, maintains that Kellogg designed Heartwise cereal for use in the cure, mitigation, treatment, or prevention of elevated serum cholesterol and diseases of the circulatory system. Determination of intent, particularly the intent of a non-natural person such as Kellogg, cannot be resolved short of trial.

10. Kellogg has not shown that any state or federal agency or any court has ever determined that psyllium, at the levels found in Heartwise, is "generally recognized as safe" ("GRAS") for human consumption. Fulgoni dep. 61:5-66:25.

11. The United States Food and Drug Administration ("FDA") has never determined that psyllium is GRAS for foods at the levels found in Heartwise. Fulgoni dep. 65:21-66:3. Although Kellogg has requested such a finding from FDA, to date that agency has not made that determination. Indeed, in one document before the court that indicates the FDA's preliminary position, a high-ranking FDA official raises concerns about (1) the potentially misleading nature of claims on Heartwise labelling; (2) the introduction of significant amounts of psyllium into food without an appropriate safety review; (3) specific safety concerns associated with the use of psyllium, including allergic reactions; (4) the inapplicability of the conclusions of the SCOGS¹ committee; (5) the inadequacy of data with respect to drug use of psyllium to establish its safety in foods; and (6) whether, at the levels of psyllium in Heartwise, Heartwise may be a drug or a delivery vehicle for a drug. Fulgoni aff. exhibit C.

12. Kellogg has not shown that FDA has recognized psyllium as safe and effective for reducing serum cholesterol. In fact, the FDA rejected just such a request filed with it by the manufacturer of Metamucil. Fulgoni dep. 67:14-20; affidavit of Joselle M. Albracht ("Albracht aff.") exhibit 3 at 1.

13. The position of the FDA with respect to cholesterol reduction claims for foods is set forth in a recent regulatory letter sent to the Ralston Purina Company regarding Oat Chex cereal. The FDA said that the "potential hypocholesterolemic effects associated with intakes of dietary fibers ... are generally limited to the soluble components of dietary fibers when consumed by hyperlipidemic individuals at very high levels as part of a low fat, low saturated fatty acid and low cholesterol total diet.... To date the Food and Drug Administration has not yet made an independent determination as to whether there is an adequate scientific basis to support label claims that soluble fiber ... is effective in lowering serum blood cholesterol and risk of coronary heart disease in the U.S. population." Albracht aff. exhibit 2.

14. The cholesterol-lowering effect Kellogg asserts for psyllium is not attributable to its nutritional value when consumed over time, as is the case with a food, but rather as the result of an immediate pharmacological response, as is the case with a drug. Fulgoni aff. exhibit J at 3. The clinical studies relied upon by Kellogg are short term studies that purport to demonstrate an immediate cholesterol-reducing effect attributable to psyllium. See, e.g., Fulgoni aff. exhibit F at 550 (three-week study), 928 (eight-week study), and 1006 (five-week study).

B. Safety of Psyllium

15. Dr. Victor L. Fulgoni, III, vice president of research and nutrition for Kellogg, made a private determination in March of 1988 that psyllium is GRAS within the meaning of 21 U.S.C. § 321(s). He based his analysis on 19 items of published literature, including a 1982 report of the eleven member Select Committee on GRAS Substances. Fulgoni aff. ¶ 10 and exhibit B; Fulgoni dep. 54:11-55:5; 72:3-75:17 (confirming conclusion as to psyllium's GRAS status). He was unable, however, after a lengthy search of scientific articles on psyllium, to find any indication that psyllium was safe in food in the levels found in Heartwise. Fulgoni dep. 74:2-6.

16. SCOGS did not make a determination that psyllium was safe for use in foods at the levels found in Heartwise. On the contrary, SCOGS said only that psyllium in foods in a level one-twentieth that found in Heartwise was safe. Fulgoni dep. 66:13-23, 65:5-10. There is no indication that SCOGS anticipated the use of psyllium at the levels found in Heartwise. Fulgoni aff. exhibit J at 2.

17. Although psyllium was previously listed by the FDA as GRAS for consumption in food in a very small concentration as an ice cream stabilizer, even that use is not currently listed by the FDA as GRAS. Fulgoni dep. 64:10-65:4.

18. In reaching its conclusions regarding psyllium, SCOGS did not review any significant food use, but only drug use as a bulk laxative in products such as Metamucil and Fiberall. Fulgoni aff. exhibit D.

19. In fact, SCOGS found in 1982 that there were no current food uses of psyllium. Fulgoni aff. exhibit D and exhibit J at 2.

20. At this time, the only generally recognized use of psyllium for human consumption in this country is as a bulk laxative in products such as Metamucil and Fiberall. As such, psyllium is a known drug active, having been recognized by the FDA as safe as a bulk laxative. Fulgoni aff. ¶ 14 and Albracht aff. exhibit 3.

21. Heartwise, by virtue of the manner in which it has been produced and marketed, is a delivery medium for psyllium, a known drug active. Albracht aff. exhibit 3.

22. The Procter & Gamble Company, a competitor of Kellogg, has opposed any FDA determination that psyllium is GRAS for food use, despite the fact that Procter & Gamble sells a drug product, Metamucil, that contains psyllium in approximately the same levels as are present in Heartwise. Fulgoni aff. exhibit J and Albracht aff. exhibit 3. Procter & Gamble has also objected to the use of psyllium in food in connection with a cholesterol reduction claim, because it was previously prohibited from making such a claim. Albracht aff. exhibit 3.

23. The FDA has recently written to Kellogg with respect to statements Kellogg has made to the court in this lawsuit, in order "to correct certain statements or impressions ... about the meaning of FDA regulatory activity concerning...