FTC v. Pharmtech Research, Inc.

• Citation: 576 F. Supp. 294
• Decision Date: 30 November 1983
• Docket Number: Civ. A. No. 83-2247.
• Parties: FEDERAL TRADE COMMISSION, Plaintiff, v. PHARMTECH RESEARCH, INC., Defendant.
• Court: U.S. District Court — District of Columbia

576 F. Supp. 294

FEDERAL TRADE COMMISSION, Plaintiff, v. PHARMTECH RESEARCH, INC., Defendant.

Civ. A. No. 83-2247.

United States District Court, District of Columbia.

November 30, 1983.

Melvin Orlans, Leslie Rice Melman, Andrew Burton Sacks, Reid Brian Horwitz, Div. of Advertising Practices, F.T.C., Washington, D.C., for plaintiff.

Charles Lister, Covington & Burling, Washington, D.C., for defendant.

MEMORANDUM OPINION

BARRINGTON D. PARKER, District Judge:

In this proceeding, the Federal Trade Commission ("FTC" or "Commission") challenges certain advertisements disseminated by the defendant Pharmtech Research, Inc. ("Pharmtech"). The advertisements are challenged on the grounds that they are false, misleading and deceptive within the meaning of sections 5(a) and 12 of the Federal Trade Commission Act ("Act"). 15 U.S.C. §§ 45(a), 52. As provided by the statute, the FTC filed an administrative complaint in July 1983 against the defendant. The FTC now seeks an injunction under sections 13(a) and (b) of the Act, restraining Pharmtech from disseminating the challenged advertisements, pending the outcome of the administrative proceedings before the Commission. 15 U.S.C. § 53(a), (b). Pharmtech does not challenge the appropriateness of venue in the District of Columbia or the jurisdiction of this Court.

The Court has considered the legal memoranda, affidavits, and oral argument of counsel and concludes that the FTC's application for a preliminary injunction should be granted. The reasons for that determination are set out in this Memorandum.

FACTUAL BACKGROUND

Pharmtech, a California corporation, manufactures Daily Greens, a dietary or food supplement in tablet form.¹ The label affixed to the Daily Greens bottle indicates that the tablets contain vitamins A, C, and E, the mineral selenium, beta-carotene and dehydrated vegetables. Each tablet provides 3 calories and, taken daily, is at most equivalent to 4.2 servings of fresh cabbage per month. Thus, each tablet provides approximately a one-seventh serving of cabbage. Plaintiff's Motion for a Preliminary Injunction ("FTC Motion"), Ex. 26, Report of William Vaughan.²

Since March 1983 Pharmtech has placed advertisements for Daily Greens in various magazines and newspapers, and has disseminated similar television advertising since July 1983. A typical print advertisement states:

Cabbage, Brussels Sprouts, Carrots, Cauliflower, Spinach and Broccoli vs. Cancer....

According to the National Academy of Sciences, a regular diet of cruciferous (cabbage, brussels sprouts, broccoli, cauliflower) and carotene-rich (carrots and spinach) vegetables is associated with a reduction in the incidence of certain cancers.*

Of course you may not really like these vegetables. Or you may not cook them quite right. And even if you have all that worked out, you still have to contend with seasonal availability. That's why there are Daily Greens.

Daily Greens are concentrated servings of cruciferous and carotene-rich vegetables. Picked ripe. Carefully washed. And quickly dehydrated without cooking. Then they're fortified with vitamins A, C, E, betacarotene and selenium.... The National Academy of Sciences thinks a balanced diet may reduce your risk of cancer. Daily Greens were designed to be a part of that balanced diet .... Substantial evidence exists that regular consumption of cruciferous vegetables is associated with a reduction in the incidence of certain cancers. Thanks to the process of dehydration, Daily Greens allow you to eat cruciferous vegetables regularly, with the convenience of a food supplement....

* Diet, Nutrition and Cancer, Committee on Diet, Nutrition and Cancer, National Academy Press, 1982 ....

Exs. 1-4.

The photoboard of the television advertisements for Daily Greens states that:

The following message concerns a revolutionary new concept in diet and nutrition. According to this report, commissioned by the National Cancer Institute, a combination of chrysipherous, sic and carotene rich vegetables, have been proven to help our bodies build certain important biological defenses. Of course, to get the most benefit from any vegetable, you should eat them raw. But that's difficult to do everyday. So I'd like to introduce you to Daily Greens. Daily Greens are not just another vitamin pill. They're natural, fresh, chrysipherous sic and carotene rich vegetables, dehydrated and compressed, to give you the important nutritional supplements, that could be so vital to your future health .... So, if you're not getting enough raw vegetables, everyday, rely on Daily Greens ... To help your body defend itself.

Radio T.V. Reports, FTC Reply, Attachment 1.

Although the challenged advertisements differ in minor respects, each makes the claim that the consumption of Daily Greens is associated with a reduction in the risk of certain cancers. The claim is also made that Daily Greens will contribute to certain biological defenses. The advertisements do not state that the use of Daily Greens will prevent cancer, nor does the FTC allege that Pharmtech makes this claim.

In making these claims, defendant relies solely on a report published by the National Academy of Sciences, entitled Diet, Nutrition and Cancer. Ex. 36. That publication ("the Report") presents the results of a comprehensive study conducted by a 13-member committee of the National Research Council, the Committee on Diet, Nutrition and Cancer ("Committee") on the relationship between eating habits and cancer. The Committee concluded that frequent consumption of certain fruits and vegetables is associated with a reduction in the incidence of cancer in human beings, and found that carotene-rich vegetables, such as carrots, and cruciferous vegetables, such as broccoli, cabbage and brussels sprouts, provide this benefit. Ex. 36 at 1-15, 15-9. Thus, it recommended that people consume carotene-rich and cruciferous vegetables daily. Ex. 36 at 1-15.

The Report, however, limited the application of its findings by several specific and cautionary warnings. First, the Committee stated that scientists have not identified the specific compounds responsible for the reduced incidence of cancer, Ex. 36 at 1-3, 15-1, 15-9, and in fact, this benefit may be completely unrelated to the chemical composition of the vegetables studied. Instead, the benefit may be due to the fact that people who eat vegetables eat fewer foods that cause cancer. Ex. 36 at A-12.

Second, the Report also warned that:

these recommendations apply only to foods as sources of nutrients — not to dietary supplements of individual nutrients. The vast literature examined in this report focuses on the relationship between the consumption of foods and the incidence of cancer in human populations. In contrast, there is very little information on the effects of various levels of individual nutrients on the risk of cancer in humans. Therefore, the committee is unable to predict the health effects of high and potentially toxic doses of isolated nutrients consumed in the form of supplements.

Ex. 36 at 1-15 (emphasis added). It further elaborated on the potential hazards of supplementation with vitamin A and selenium, Ex. 36 at 1-9 through 1-10, 9-7, and drew no firm conclusions about the effect of vitamin E and selenium on cancer in human beings. Ex. 36 at 1-8, 9-12, 10-7. These warnings are relevant because they emphasize that the findings apply to foods as people typically consume them, not to dietary supplements.³

Lastly, the Report relied on studies of the consumption of raw or whole vegetables. Ex. 36 at 15-1 through 15-2. The Report cautioned that the removal of water which occurs during dehydration may alter the protective effect of nutrients and other compounds. The Committee admonished that dehydrated foods are "processed" foods which "produce significant structural and possibly major chemical changes including nutrient loss." Ex. 36 at A-5 n. 1.

LEGAL ANALYSIS

1. The Standard for Injunctive Relief

The Court has the authority to issue a preliminary injunction under sections 13(a) and 13(b) of the Act. 15 U.S.C. § 53(a), (b). Section 13(a) authorizes the issuance of a preliminary injunction upon a proper showing that false advertising has been disseminated and that the public interest would be served by such an injunction.⁴ While section 13(b) similarly provides for the issuance of a preliminary injunction, the reach of 13(b) is broader than 13(a). An injunction may be issued under section 13(b) for the violation of any provision of law enforced by the FTC, including both false advertisements and misleading and deceptive advertisements.⁵

Congressional approval of these two sections governing injunctive relief has resulted in some uncertainty as to the applicable standards in false and deceptive advertising cases. The Seventh Circuit has firmly held that a proper showing under section 13(a), as distinct from 13(b), requires only that the FTC have "reasonable cause" to believe that the defendants were engaged in the dissemination of false advertisements. See FTC v. National Commission on Egg Nutrition, 517 F.2d 485, 488-89 (7th Cir.1975) (following FTC v. Rhodes Pharmacal Co., 191 F.2d 744, 747-48 (7th Cir.1951)), cert. denied, 426 U.S. 919, 96 S.Ct. 2623, 49 L.Ed.2d 372 (1976). The Ninth Circuit, in contrast, has held that the standards for a preliminary injunction under sections 13(a) and 13(b) are identical. See FTC v. Simeon Management Corp., 532 F.2d 708, 712-14 (9th Cir.1976). The United States Court of Appeals for the District of Columbia has not as yet decided whether the FTC's burden differs under the two sections. In this case, the issue need not be resolved for the reason that the evidence establishes that the Commission has met the arguably stricter standard set forth in section 13(b).

In addition to its broader reach, section 13(b) more specifically sets forth the standards governing the issuance of a preliminary injunction. A preliminary...