United States v. Alberty Food Products

• Decision Date: 08 June 1951
• Docket Number: No. 10322.,10322.
• Citation: 98 F. Supp. 23
• Court: U.S. District Court — Southern District of California
• Parties: UNITED STATES v. ALBERTY FOOD PRODUCTS et al.

98 F. Supp. 23

UNITED STATES v. ALBERTY FOOD PRODUCTS et al.

No. 10322.

United States District Court S. D. California, Central Division.

June 8, 1951.

Ernest A. Tolin, U. S. Atty., Max F. Deutz, Asst. U. S. Atty., Los Angeles, Cal., for plaintiff.

O'Connor & O'Connor, Los Angeles, Cal., for defendants.

MATHES, District Judge.

The Government invokes the jurisdiction of this Court under § 302(a) of the Federal Food, Drug and Cosmetic Act, 52 Stat. 1043, 21 U.S.C.A. § 332(a), to enjoin alleged violations by defendants of § 301 which prohibits "introduction * * * into interstate commerce of any * * * drug * * * that is * * * misbranded." 21 U.S.C.A. § 331(a).

The amended complaint for injunction alleges inter alia:

That defendants are "the manufacturers, packers and distributors of certain articles of drug * * *";

That "For some years, defendants have introduced said articles of * * * drug into interstate commerce, and have caused said articles to be accompanied by various leaflets and booklets when introduced into and while in interstate commerce and while held for sale after shipment in interstate commerce. Said leaflets and booklets are entitled `Calcium, The Staff of Life' Exhibit 30; `Dynamic Digests' Exhibit 31; `Is There Hope That Graying Hair Can Be Restored? Read What Science Says — Pandora' Exhibit 32; `Health Mysteries' Exhibit 33; `Reduce! Streamline Your Figure — Follow the 5 Factor Cheno Plan' Exhibit 34; `Happy Figures by the Cheno Plan' Exhibit 35. Each of these booklets and leaflets relates to one or more of the above mentioned articles of drug * * *";

That "At all times, the aforesaid articles of drug, when introduced into interstate commerce, have been and are now misbranded within the meaning of section 502(f) (1) of the Act, 21 U.S.C.A. § 352(f) (1), in that their labelings fail to bear adequate directions for use for the purposes and conditions for which they are intended."

At pretrial hearing the parties stipulated:

(1) That "defendants' products referred to in the Amended Complaint for Injunction are drugs and are shipped interstate by the defendants."

(2) That "Defendants ship all of their products in interstate commerce to health food retail outlets and intend to continue so shipping these products. Defendants also ship these products interstate direct to ultimate consumers in response to mail orders from such persons."

(3) That "Defendants are currently distributing the above mentioned literature interstate in the following ways * * *:

"(a) Defendants obtain the names and addresses of prospective customers from the retail outlets to which they sell their products. Defendants mail said literature to said prospective customers, and on such literature defendants print the name and address of the retail outlet that furnished such names and addresses.

"(b) Defendants also obtain the names and addresses of prospective customers from demonstrators who are hired by the defendants to work in retail outlets and there promote the sale of defendants' products. Defendants mail the aforesaid literature to said prospective customers, and on such literature defendants print the name and address of a retail outlet located in the same area as the prospective customer.

"(c) Defendants also obtain the names and addresses of prospective customers when individuals write in to the defendants for literature or to submit mail orders. Defendants mail the aforesaid literature to said prospective customers, and on such literature defendants print the name and address of a retail outlet located in the same area as the prospective customer."

Section 201 of the Act provides in part that:

"(k) The term `label' means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement * * * that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

"(l) The term `immediate container' does not include package liners.

"(m) The term `labeling' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article."

The parties have stipulated to the identity and content of the label used "upon the immediate container" of each article, and further that such "label", 21 U.S.C.A. § 321(k, l), constitutes the entire "labeling", 21 U.S.C.A. § 321(m), as to each article, unless the above mentioned "literature" is to be considered as "accompanying such article" in interstate commerce within the meaning of § 201(m) (2) of the Act, 21 U.S.C.A. § 321(m) (2).

Based upon the facts established by the pleadings and the pretrial stipulations, the Government has moved for summary judgment upon the ground: "That there are no facts in dispute with respect to that portion of the Amended Complaint which seeks an injunction under 21 U.S.C.A. § 332(a) to restrain defendants from violating 21 U.S.C.A. § 331(a) through the continued interstate shipment of drugs that are misbranded in violation of 21 U.S.C.A. § 352(f) (1)", which provides that: "A drug * * * shall be deemed to be misbranded * * * (f) unless its labeling bears (1) adequate directions for use * * *."

In order to determine whether the labeling as to any "drug", 21 U.S.C.A. § 321(g), bears "adequate directions for use" within the meaning of the Act it is necessary of course first to ascertain what comprises "its labeling." Section 201(m) declares that: "The term `labeling' means all labels (see 21 U.S.C.A. § 321 (k, l) and other written, printed or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." 21 U.S.C.A. § 321(m).

In Kordel v. United States, 1948, 335 U.S. 345, 347, 348, 69 S.Ct. 106, 108, 93 L.Ed. 52, where "the literature involved * * * was shipped separately from the drugs and at different times" but "had a common origin and a common destination", the literature was held to accompany the drugs in interstate commerce within the meaning of the Act, 21 U.S.C.A. § 321 (m), and so to comprise a part of the "labeling." See also United States v. Urbuteit, 1948, 335 U.S. 355, 69 S.Ct. 112, 93 L.Ed. 61; United States v. Research Laboratories, Inc., 9 Cir., 1942, 126 F.2d 42, 45.

As in the cases just cited, the literature involved at bar explains the claimed beneficial uses of each drug and was obviously "designed for use in the distribution and sale"; while the "label" itself is either totally or practically silent as to the purpose for which the drug is to be used; and usually, but not invariably, both the drug and the literature describing it have a common point of origin in interstate commerce. The point of difference in the case at bar is that generally speaking the article and the literature do not have a common destination, since defendants usually ship the drugs to a retail outlet, while the literature is shipped directly to prospective consumers.

Thus the precise question on this phase of the case is whether the literature may properly be held to accompany the drug in interstate commerce within the meaning of 21 U.S.C.A. § 321(m) (2), where the destination of the literature when shipped is not the distributor or consumer of the drug.

The policy of the Act seems clearly to require that "labeling", 21 U.S.C.A. § 321(m), which bears "adequate directions for use", 21 U.S.C.A. § 352(f) (1), of the drug be placed "upon the immediate container", 21 U.S.C.A. § 321(k, l), or accompany the container so closely that the ordinary consumer will be apprised of all directions, cautions and other information appearing thereon.

Section 201(k) provides that "a requirement * * * that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper." 21 U.S.C.A. § 321(k).

Section 201(n) provides that: "If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual." 21 U.S.C.A. § 321(n).

And § 502 declares that: "A drug or device shall be deemed to be misbranded —

"(a) If its labeling is false or misleading in any particular. * * *

"(c) If any word, statement, or other information required * * * to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. * * *

"(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: * * *

"(j) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or...