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UNITED STATES v. 7 CARTONS

December 16, 1968

UNITED STATES OF AMERICA
v.
7 CARTONS, MORE OR LESS * * * LABELED IN PART * * * "FERRO-LAC SWINE FORMULA CONCENTRATE (MEDICATED)".



The opinion of the court was delivered by: Robert D. Morgan, District Judge.

MEMORANDUM DECISION ON MOTION FOR PARTIAL SUMMARY JUDGMENT

This is a civil action in rem arising under the provisions of the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 301 ff.

This cause is now before the court upon the motion of the United States for partial summary judgment.

On or about March 22, 1966, claimant, Naremco, Inc., shipped 7 Cartons, each containing 12 bags, of a product labeled "Ferro-Lac Swine Formula Concentrate (Medicated)" in interstate commerce from Springfield, Missouri, to Atkinson, Illinois. This libel is directed against those 7 Cartons of Ferro-Lac.

The libel alleges that there were three violations of the Act in the shipment of the product in interstate commerce.

First, it alleges that Ferro-Lac is a new drug, within the meaning of 21 U.S.C. § 321(p), which was unlawfully introduced into interstate commerce without an approved "new-drug" application in effect with respect to the product in violation of 21 U.S.C. § 355(a).

Second, it alleges that Ferro-Lac is a food within the meaning of 21 U.S.C. § 321(f), and that the article is adulterated as a food within the meaning of 21 U.S.C. § 342(a) (2)(C), in that it contains a combination of food additives which are unsafe within the meaning of 21 U.S.C. § 348, because the use and intended use of the combination of additives are not in conformity with any regulation or exemption promulgated pursuant to 21 U.S.C. § 348.

Third, it alleges that the commodity is misbranded as a drug within the meaning of 21 U.S.C. § 352(a).

The government's motion for partial summary judgment is directed to the "new drug" and adulterated food issues.

The active ingredients of the product, labeled and sold by claimant for use as an additive to food for swine for the prevention and treatment of infectious nonspecific diarrhea and bacterial interitis, are sodium propionate, sodium phthalysulfacetamide and methylrosaniline chloride.

The parties have stipulated that the product is a drug within the meaning of 21 U.S.C. § 321(g) and that no new drug application is in effect with respect thereto. They further stipulate that the product is a food within the meaning of 21 U.S.C. § 321(f).

The test whether a drug is a "new drug" within the meaning of the statute is whether its composition is such that it "is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use" as prescribed by the labeling. 21 U.S.C. § 321(p). A like test of general recognition by qualified experts applies to the question whether any given product is an unsafe food additive. 21 U.S.C. § 321(s), 342(a) (2)(C), 348.

In addition to the pleadings and the answers of the parties to interrogatories, there are before the court on this motion for summary judgment affidavits submitted by the government in support of the motion, and by the claimant in opposition thereto.

To a degree, there is some conflict between the affidavits submitted by the government and those submitted by the claimant.

The government contends that any conflict between the affidavits of experts related to the question of general recognition proves the want of general recognition of the statutory factors. Three district court cases are cited by the government which do tend to lend support to that theory. Merritt Corp. v. Folsom, D.D.C., 165 F. Supp. 418, 421 (1958); United States v. 354 Bulk Cartons, etc., D.N.J., 178 F. Supp. 847, 853 (1959); United States v. Article of Drug, etc., N.D.Ga. 1968, 294 F. Supp. 1307.

Actually only two of those cases arose in the summary judgment context, and neither contains any well-reasoned basis for the conclusion that a conflict of relevant expert opinion is proof of a want of general recognition as a matter of law. In the Merritt case, that principle is stated as a conclusion of law, without any opinion or analysis. In 354 Bulk ...


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