California Canners & Growers Ass'n v. United States

9 Cl. Ct. 774, 1986 U.S. Claims LEXIS 882
CourtUnited States Court of Claims
DecidedApril 18, 1986
DocketCong. Ref. No. 2-77
StatusPublished
Cited by29 cases

This text of 9 Cl. Ct. 774 (California Canners & Growers Ass'n v. United States) is published on Counsel Stack Legal Research, covering United States Court of Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
California Canners & Growers Ass'n v. United States, 9 Cl. Ct. 774, 1986 U.S. Claims LEXIS 882 (cc 1986).

Opinion

REPORT OF REVIEW PANEL

Senate Resolution No. 225, referred the pending bill S.1894, 95th Cong., 1st Sess., to the Chief Judge of the United States Claims Court for action in accordance with 28 U.S.C. §§ 1492 and 2509. After a trial of nearly twelve weeks, and compilation of a record of more than 5,000 pages of transcript and 1,000 exhibits, the hearing officer filed an exhaustive report which accompanies this review. Only so much of the substance of the report as is necessary to the review panel decision is recited here.

Background

An amendment of the Food, Drug, and Cosmetics Act (FDCA) in 1958 defined most food ingredients as “food additives,” and provided a statutory framework for pre-market safety testing by manufacturers and processors, and approval by the Food and Drug Administration (FDA) before those ingredients were used in food. The proponent of a food additive was required to prove its safety to the FDA which signified its approval by the issuance of a food additive regulation. The definition of food additive excluded any ingredient that is

generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use____

21 U.S.C. § 321(s). This exclusion resulted in FDA’s issuance of its “generally recognized as safe” or GRAS list. 21 C.F.R. § 121.101. Therefore, substances which are food additives and those which are GRAS are mutually exclusive.

By exempting GRAS substances from the definition of food additive, Congress allowed the marketing of GRAS substances without the pre-market safety testing and prior government approval required for food additives. This established that ingredients which had long been used in foods without apparent harmful effects, such as salt, sugar and other familiar substances, would not have to undergo extensive new testing to be used in food products.

Except for the definition, no further clarification of the term “generally recognized as safe” was provided. The new legislation required the courts, rather than the FDA, to determine if a substance is GRAS. Nevertheless, because whether or not a substance is GRAS determines if it can be marketed without the prescribed testing and approval, the FDA issued a list of substances which it believed were GRAS as a guide to its personnel and as advice to the regulated industries.

The regulation embodying the GRAS list, however, stated that

It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use. The lists in paragraph (d) of this section include additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner as safe for such uses.

21 C.F.R. § 121.101(a). The subparagraph (d) referred to in the regulation included the artificial, nonnutritive sweeteners, sodium cyclamate and calcium cyclamate.

At a press conference on October 18, 1969, the Secretary of Health, Education [777]*777and Welfare announced that he was “ordering the artificial sweetener, cyclamate, be removed from the list of substances generally recognized as safe for use in foods.” He continued, in relevant part, as follows:

Recent experiments conducted on laboratory animals disclosed the presence of malignant bladder tumors after animals had been subjected to strong dose levels of cyclamates for long periods. The findings of these experiments form the basis for my action.
The fact that cyclamates have induced cancer in animals was confirmed by a panel of the National Academy of Science, which unanimously reported its findings to me late yesterday. The academy met in special session at my request to review the results of various research projects involving cyclamates. Before I go any further, let me emphasize in the strongest possible terms that we have no evidence at this point that cyclamates have indeed caused cancer in humans.
Thus, my decision to remove cyclamates from the list of approved substances in no sense should be interpreted as a “life saving” or emergency measure. I have acted under the provisions of law because it is imperative to follow a prudent course in all matters concerning public health.

The Secretary also said the use of cyclamates in general purpose foods and beverages was to be discontinued immediately; that general purpose foods and beverages were to be withdrawn from the marketplace in accordance with a stated schedule; and products containing cyclamates would remain available to persons whose health depended upon them, if they were labelled as drugs to be consumed upon the advice of a physician. The Secretary made subsequent statements reported on television that there was “solid evidence that [cyclamates] produced cancer in the bladder of mice and rats” and that “cyclamates are very clearly carcinogenic.”

The same day, the United States Surgeon General made these remarks:

I want to begin by reinforcing as strongly as I can the statement by Secretary Finch on the meaning of the scientific findings which provide the basis for the action being taken here today. There is absolutely no evidence to demonstrate in any way that the use of cyclamates has caused cancer in man. There is no evidence that the use of cyclamates has caused malformation in children or any other abnormality in humans, other than a rare skin hypersensitivity.
The decisions being announced here today are based on bladder tumors obtained by feeding massive doses of cyclamates throughout the life span of rats. The dosage thus shown to cause these tumors in rats is 50 times the maximum amount previously proposed for adult human ingestion by the National Academy of Sciences and by the World Health Organization.
As I stated a few moments ago developments leading to our presence here today began on Monday of this week when Dr. Umberto Saffiotti, Associate Scientific Director for Carcinogenesis with the National Cancer Institute, notified me that Abbott Laboratories had important new data regarding cyclamates. On Tuesday, October 14, I met with Dr. James Price, Abbott Vice President for Experimental Therapy, and other Abbott officials. They reviewed data they obtained from University of Wisconsin studies in June 1969 which showed that cholesterol pellets with 20 percent sodium cyclamate produced significantly increased numbers of urinary bladder tumors when injected into the cavity of the urinary bladder of Swiss mice. The tumors were found when the mice were sacrificed after 16 months.

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9 Cl. Ct. 774, 1986 U.S. Claims LEXIS 882, Counsel Stack Legal Research, https://law.counselstack.com/opinion/california-canners-growers-assn-v-united-states-cc-1986.