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