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NATIONAL NUTRITIONAL FOODS ASSN. v. YOUNG

December 14, 1984

THE NATIONAL NUTRITIONAL FOODS ASSOCIATION AND SOLGAR CO., INC., Plaintiffs, v FRANK E. YOUNG, M.D., COMMISSIONER OF FOOD AND DRUGS, AND FOOD AND DRUG ADMINISTRATION, Defendants.


The opinion of the court was delivered by: POLLACK

DECISION AND OPINION

MILTON POLLACK, Senior United States District Judge

 MILTON POLLACK, Senior District Judge

 This is a suit for an injunction and declaratory judgment which seeks to invalidate regulations of the Food and Drug Administration ("FDA") promulgated on April 6, 1984 and applicable to high-concentrate food products deriving more than 50% of their caloric value from protein. Plaintiffs challenge the warning labels required on such food products as arbitrary and capricious, and as unsupported by the administrative record of the Agency.

 Jurisdiction of the Court over this suit resides in 28 U.S.C. §§ 1332 and 1391(a). In July, 1984, this Court denied plaintiff's application for a preliminary injunction which sought to hold up the effective date, August 6, 1984, of the regulations. The Court found, at that time, that defendant had demonstrated a "reasonable basis for addressing the hazards posed by the use of low caloried protein diets." National Nutritional Foods Ass'n. v. Novitch, 589 F.Supp 798, at 801 (SDNY 1984) (Pollack, J.). The issues were then presented at a Bench Trial concluded on December 10, 1984.

 The plaintiffs' contentions turn basically on the answer to the question whether the requirements of the regulations at issue are adequately supported by rational judgments as to relevant material to be found in the Agency's administrative record, which is comprised of 12,412 pages of material. 5 U.S.C. § 706 (2)(A); Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420, 28 L. Ed. 2d 136, 91 S. Ct. 814 (1971).

 Upon due deliberation, the Court finds and decides that the regulations of the Agency questioned herein establish rational thresholds as well as reasonable and proper warning and notices to be affixed to the protein products and that these are supported by substantial evidence in the administrative record and are reasonably and necessarily required in the protection of the public interest.

 In detail, the findings of fact and conclusions of the Court follow.

 Background

 Some seven years ago, an alarming incidence of illness and deaths was reported that was associated with persons who were on certain liquid protein diets which were being widely promoted and recommended at the time. Those reports prompted the FDA to conduct an investigation and ultimately to propose the predecessors of the current regulations. 42 Fed. Reg. 61285-61287, (December 2, 1977). The regulation at issue in this action, as modified, was promulgated by the FDA on April 6, 1984 (21 C.F.R. § 101.17(d)). It establishes three types of required label and labeling statements for:

 "any food product in liquid, powdered, tablet, capsule or similar forms that derives more than 40 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures or a combination of these, and that is represented for use in reducing weight" . . . (regulated protein products)

 (49 Fed. Reg. 13679-13689, April 6, 1984).

 The background which precipitated the original form of the regulations and of the modifications thereof over a period of seven years leading up to the 1984 version, is instructive. The findings and conclusions of the FDA giving the reasons and explanation for the promulgation of the regulations are set forth in the preambles to the various Federal Register announcements issued during the course of the administrative proceedings.

 In 1976 and 1977, a book entitled "The Last Chance Diet" was written by a Dr. Robert Linn popularizing the use of "pre-digested liquid protein supplements," and proclaiming them as essentially the only source of nourishment in a weight reduction program. This diet reached widespread fad proportions and involved the ingestion of less than 400 calories per day. As a result of this book and other promotional materials, some of the regulated protein products which were either specifically labeled for use in diets providing more than 400 calories per day, or as food supplements, were used in diets of less than 400 calories per day.

 The National Center for Disease Control ("CDC") conducted a portion of the investigation of the casualties reported following the protein dieting described and found inter alia that the death rate among people adhering to very low calorie diets in conjunction with regulated protein products was, while the diet was popular, 37 times greater than the death rate in the general population. The CDC further concluded that the clinical electrocardiographic pattern of the deaths reported was highly suggestive of death by starvation.

 As a result of such investigation, FDA had determined that use of the regulated protein products in diets of less than 400 calories per day ("very low calorie diets") may cause serious illness or sudden and unexpected death from cardiac arrest and that such diets should not be undertaken ...


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