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July 24, 1980


The opinion of the court was delivered by: POLLACK


Plaintiffs have applied for a preliminary injunction pursuant to Rule 65(a) of the Federal Rules of Civil Procedure, enjoining the Food and Drug Administration ("FDA") and its Commissioner from enforcing a regulation entitled "Protein Products; Warning Labelling", 21 C.F.R. § 101.17, as published at 45 Fed.Reg. 22913-14 (April 4, 1980), which is scheduled to go into effect August 4, 1980. This regulation requires that warning labels be put on certain food products deriving 50% or more of their caloric value from protein; the warning required varies according to the use for which the product in question is promoted, but in the case of protein products promoted for use in weight reduction the warning includes the statement that "Very low calorie protein diets . . . may cause serious illness or death."

 The substance involved in this dispute is not a toxic product.

 For the reasons shown hereafter a preliminary injunction will issue postponing the effective date of the regulation until September 4, 1980 and until such further time as the Court may order. A trial of the merits is set down for August 18, 1980 in Courtroom 1306 at 10:30 A.M.

 Plaintiffs (a trade association of producers of concentrated protein products, and a particular manufacturer thereof argue that the ominous and forbidding character of the warnings required in particular the death warning is unjustified and irreparably damaging to the marketability of concentrated protein products. Plaintiffs contend that the regulation in question exceeds FDA's statutory authority, is arbitrary and discriminatory, and has been promulgated without affording plaintiffs and the public at large a required and meaningful opportunity to participate in the rulemaking process.

 Defendants argue in opposition to the motion that plaintiffs have not made the requisite showings of irreparable harm, substantially meritorious questions, and a balance of hardships tipping in their favor to entitle them to preliminary relief.

 Events leading to the regulation in question

 Sometime in 1977, FDA began receiving reports of death and serious illness associated with the use of very low calorie liquid protein diets. FDA proceeded for the next two and a half years to study the role that the use of concentrated protein products played in these incidents. At the end of this investigatory period, it appears that FDA was unable to find any causal relationship between the use of protein concentrates per se and the reported deaths, and that it concluded instead that the "pathologic pattern of these deaths was highly suggestive of death by starvation." 45 Fed.Reg. 22907 (April 4, 1980).

 FDA concedes that the protein products at issue are themselves of unquestioned safety and nutrition, and "does not contend that protein concentration, per se, is one of the causes of the problems" that the regulation is intended to remedy. FDA also concedes that the last reported death from "starvation" dietary use of protein products occurred in the Spring of 1978, some two years ago. This lends considerable support to plaintiffs' contention that the deaths resulted from a fad diet (which was not promoted by the manufacturers of the product) that arose some years back a fad that has now subsided.

 Nonetheless, FDA promulgated the regulation at issue, purportedly on the ground that:

In light of the evidence of the risks to health associated with the use of protein products in very low calorie diets, failure to warn consumers of those risks on the label of the protein products constitutes omission of a material fact about the products. Omission of that fact renders the label for the products "false or misleading" and the products, therefore, misbranded (under 21 U.S.C. § 343(a)).

 To be entitled to preliminary injunctive relief, a plaintiff must make a showing of "(a) irreparable harm and (b) either (1) likelihood of success on the merits or (2) sufficiently serious questions going to the merits to make them a fair ground for litigation and a balance of hardships tipping decidedly toward" plaintiff. Jack Kahn Music Co. v. Baldwin Piano & Organ Co., 604 F.2d 755, 758 (2d Cir. 1979).

 In this case, plaintiff has certainly raised substantial questions concerning the propriety and validity of FDA's promulgation of the regulation in question. In order for a regulation not to be arbitrary, capricious or discriminatory, it must be sustainable on the administrative record, Camp v. Pitts, 411 U.S. 138, 143, 93 S. Ct. 1241, 1244, 36 L. Ed. 2d 106 (1973); moreover, a "regulation perfectly reasonable and appropriate in the face of a given problem may be highly capricious if that problem does not exist." Chicago v. F.P.C., 147 U.S. App. D.C. 312, 458 F.2d 731, 742 (D.C. Cir. 1971), cert. denied, 405 U.S. 1074, 92 S. Ct. 1495, 31 L. Ed. 2d 808 (1972).

 Thus, putting aside the substantial points raised by plaintiff concerning the procedures followed by FDA, it is seriously questionable and requires evidentiary support which has not been furnished that, despite the absence for two years of any deaths attributed to "starvation" dietary use of protein products, a "death warning" is required to prevent a seemingly safe food product from being "misbranded". This is particularly so where there is lacking any evidentiary foundation of a causal relationship between the protein products and the deaths that did occur, or any evidence before the Court that the producers of the goods in question promoted or were otherwise responsible for the abuse of ...

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