AMEND SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT 5 Mills, Inc., Russell-Miller Refining Co., International Milling Co., King Midas Milling Co., Ballard & Ballard Milling Co., and Standard Milling Co., or a total capacity representation of approximately onethird of the milling industry of the United States. 3 Three witnesses who appeared before your commit represented milling companies in the West and Southwest. They expressed their approval of the Food and Drug Act and of the legislation here proposed but asked for a further amendment; namely, an amendment relating to the proof required in criminal proceedings under the act. This is a new proposal and in the opinion of your committee is not germane to the issue bere presented. Your committee wishes to reiterate that all of the witnesses recommending this additional change in the law have endorsed this bill. Mr. E. W. Morrison of Denton, Tex., one of the leading millers in that part of the country, who appeared in behalf of a substantial number of millers of Texas, Oklahoma, and Kansas, stated at the hearing: we have no objection to the Miller bill." Enactment of H. R. 4071 is urgent. There is a definite hazard to public health and welfare each day it remains unenacted. Therefore your committee recommends that new or additional amendments which are not germane to this legislation be handled as separate bills in order that the public and the regulated industries may have an opportunity thoroughly to appraise them. 66# * There is attached hereto and made a part of this report letters from the Federal Security Agency and the Federal Trade Commission offering their comments on the legislation. In the opinion of your committee the bill (H. R. 4071) is in the public interest and should be enacted without delay. For the information of the Senate, changes in existing law made by the bill are shown as follows (new matter is printed in italics, existing law in which no change is proposed is shown in roman): FEDERAL FOOD, Drug, and Cosmetic Act, as Amended PROHIBITED ACTS SEC. 301. The following acts and the causing thereof are hereby prohibited: * (k) The alteration. mutilation, destruction, obliteration, or removal of the whole or any part of the labeling, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded. SEIZURE SEC. 304. (a) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 404 or 505, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found: 6 AMEND SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT FEDERAL SECURITY AGENCY, The honorable the PRESIDENT PRO TEMPORE, DEAR MR. PRESIDENT: The enforcement operations under the Federal Food, Drug, and Cosmetic Act in an area vitally important to the public health and welfare have been drastically curtailed by a recent court decision. Prompt legislative action is necessary if this essential consumer protection is to be restored. commerce * Seizure of macaroni and spaghetti found to be adulterated with rodent excreta and insects was made under section 304 (a) of the act, which provides that articles which are "adulterated or misbranded when introduced into or while in interstate shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found The contamination in, this case occurred in the rodentand insect-infested warehouse of the interstate consignee where the food was stored in its original unbroken packages. The district court held that the defiled food was not adulterated "while in interstate commerce" and dismissed the libel. When the Circuit Court of Appeals affirmed, the Department of Justice petitioned the Supreme Court for writ of certiorari. The writ was denied. Thus ends an important protective public service that has been carried out for 40 years under the present law and the original pure food and drug law. Seizure and condemnation of foods and drugs that became adulterated or misbranded after interstate transportation, but which remained unloaded, unsold, or in the original unbroken packages, was authorized by the Food and Drugs Act of 1906; thousands of shipments of filthy, debased, and deteriorated foods and drugs were thereby prevented from reaching the consuming public. The record is replete with evidence that the Congress intended to make the 1938 act a more effective instrument of consumer protection than the old law. The Supreme Court in United States v. Dotterweich (320 U. S. 277), said: Nothing is clearer than that the later legislation was designed to enlarge and stiffen the penal net and not to narrow and loosen it. This purpose was unequivocally avowed by the two committees which reported the bills to the Congress. The House committee reported that the act 'seeks to set up effective provisions against abuses of consumer welfare growing out of inadequacies in the Food and Drugs Act of June 30, 1906' (H. Rept. No. 2139, 75th Cong., 3d sess., p. 1). And the Senate committee explicitly pointed out that the neu legislation 'must not weaken the existing laws,' but on the contrary 'it must strengthen and extend that law's protection of the consumer' (S. Rept. No. 152, 75th Cong., 1st sess., p. 1)." (Emphasis added.) There is nothing in the extensive legislative history of the new act, including hearings, debates, and committee reports, or in the records made at hearings on appropriation: acts where this kind of enforcement has been Ciscussed, that revca's anything but approval by the Congress and the industries concerned of the longstanding practice of condemning goods which, after their interstate journey had ended, became adulterated while unsoid or in the original package. Apparently, the Congress was satisfied with the administrative interpretation that the language "while in interstate commerce" was at least as inclusive as the language of the old law, * * having been transported [froin one State to another], remains unloaded, unsold, or in original unbroken packages 44 The magnitude of the breach in consumer protection, if it should remain unrepaired, is worthy of attention. In the last fiscal year 2,458 seizures of adulterated or misbranded food products were made. Approximately 20 percent of these actions involved cases where the adulteration clearly resulted from insanitary conditions or other causes at the terminal warehouse. In many other cases, moreover, it would have been impossible to prove that contamination or deteriora tion occurred before transportation ended. Even where this fact could have been proved, it would often have required such time-consuming investigations that much unfit food would have reached consumers' tables before legal proceedings could have been instituted. With respect to cereal products alone, terminal contamination by rodents and insects was responsible for the scizure of 4,250 tous. A lesser proportion of the drug seizures was in this category. The absence of effective control in this arca may result in serious illness and fatalities. Recently a number of poisoning cases resulted from cheese contami AMEND SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT 7. nated with toxin-producing bacteria. Later an employee of the factory confessed --something that could not have been proved by any objective examination of the cheese that a mouse drowned in the milk during manufacture and that the mouse, but not the milk, was discarded. Since the cheese was shipped very soon after it was made, it is doubtful that the toxin had developed before interstate movement ceased. The botulinus organism occurs in soil and may thus be present in many foods. If processing does not kill it and conditions for its growth are favorable, it elaborates a lethal toxin, with the effect of a delayed-action bomb. Usually the toxin is produced only after the lapse of considerable time-ample for delivery of the food to interstate points. We strongly recommend that the Congress promptly amend section 304 (a) of the act to restore consumer protection to the extensive area of commerce now rendered immune from regulation under the act. This could be accomplished by inserting the italicized words in the quotation below from section 304 (a) of the act: "SEC. 304 (a). Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale after shipment in interstate commerce, or which may not, under the provisions of section 404 or 505, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found; The wording of the proposed amendment, which relates only to seizures, is similar to that in section 301 (k) of the act which makes it a criminal offense to do any act with respect to a food, drug, device, or cosmetic while it is being held for sale after shipment in interstate commerce if such act results in misbranding the article. Such an amendment would therefore be merely a further recognition of the fact that it makes no difference to consumers of goods from interstate sources whether adulteration or misbranding occurs before introduction into interstate commerce, or during transportation in interstate commerce, or while holding for sale after such transportation. The Congress has manifested concern in other laws that its purpose of keeping offending goods out of interstate commerce be not defeated after interstate shipment by the doing of acts to the goods which result in the proscribed offenses. The Federal Caustic Poison Act of 1927 contains a criminal provision comparable to section 301 (k), and in addition authorizes seizure and confiscation of substances which become misbranded while being held for sale or exchange after interstate shipment. The Federal Alcohol Administration Act of 1935, as amended, makes it unlawful to misbrand distilled spirits, wine, or malt beverages held for sale in interstate or foreign commerce, or after shipment therein. degree than either caustic poisons or alcoholic beverages, foods and drugs are the To a much greater daily concern of all our people. The need for eliminating products that become poisonous, deteriorated, or that are defiled by rodents and insects, after their transportation in interstate commerce has come to an end, is not less than the need for protecting the public against can tic poisons and alcoholic beverages that have become misbranded after interstate shipment. The protection which Congress has carefully designed to insure the purity and wholesomeness of products during their interstate journey should not be thwarted by a failure to proscribe adulteration or misbranding which occurs after the transportation has ended but before the ultimate commercial transaction has been completed. Of the Food, Drug, and Cosmetic Act the Supreme Court has said: "The purposes of this legislation thus touch phases of the lives and health of the people which, in the circumstances of modern industrialism, are largely beyond selfprotection." The recent Court decision has revealed that, through failure to use sufficiently explicit language in the seizure section of the act, the purpose of Congress to effectuate consumer protection has been defeated in a substantial degree and its safeguards have to that extent been rendered futile. that the interests of the American public are of such magnitude as to require It is apparent prompt legislative action to assure the continuing wholesomeness and fitness for use of articles that have been transported interstate. The Bureau of the Budget advises that there is no objection to the submission of this proposed legislation to the Congress for its consideration. Sincerely yours, WATSON B. MILLER, Administrator. 8 AMEND SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT A BILL To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for seizure of foods, drugs, devices, and cosmetics that become adulterated or misbranded while held for sale after interstate shipment, and for other purposer Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 304 (a) of the Federal Food, Drug, and Cosmetic Act, as amended (21 U. S. C. 334 (a)), is amended by inserting im mediately after the words, "when introduced into or while in interstate commerce", the following: "or while held for sale after shipment in interstate commerce". Hon. CHARLES W. TOBEY, FEDERAL SECURITY AGENCY, Acting Chairman, Committee on Interstate and Foreign Commerce, United States Senate, Washington 25, D. C. DEAR MR. CHAIRMAN: This will acknowledge your letter of February 7, 1948, requesting our comments upon H. R. 4071, a bill to amend sections 301 (k) and 304 (a) of the Federal Food, Drug, and Cosmetic Act, as amended, with par ticular reference to the recent decision of the Supreme Court in United States v. Jordan James Sullivan. We previously had prepared a letter to Senator White discussing the relationship of that decision to this legislation, and it was awaiting clearance by the Bureau of the Budget when your letter was received. A copy of the letter is enclosed. Budget clearance of this and the enclosed letter has been secured. This Agency is strongly in favor of the legislation. Its purposes and the neces sities which prompted this Agency to recommend it are fully explained in H. R. Report No. 807. The Sullivan decision does not remove the need for the amendment. The regulated industries are overwhelmingly in favor of the legislation, and we are aware of no significant opposition. Recently, the section on food, drug, and cosmetic law of the New York Bar Association voted unanimously to support the bill and to urge its passage by the Senate. We respectfully request that your committee give prompt and favorable consideration to the proposed legislation. We are at the service of the Committee at all times to explain any feature of the bill. Sincerely yours, OSCAR R. EWING, Administrator. FEDERAL SECURITY AGENCY, Hon. WALLACE H. WHITE, Jr.. Chairman, Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: In its letter of April 17, 1947, to the President of the Senate and a similar letter to the Speaker of the House, this Agency recommended that Congress amend section 304 (a) of the Federal Food, Drug, and Cosmetic Act of 1938 so as to authorize seizure of foods, drugs, and cosmetics which are adulterated or misbranded "while held for sale after shipment in interstate cominerce." You were kind enough to introduce a bill in the Senate (S. 1190) proposing the amendment, and two similar bills were introduced in the House (H. R. 3128, H. R. 3147). These bills were referred to the respective committees on Interstate Commerce. The above-quoted language of the bills was drawn from section 301 (k) of the Act, a criminal provision (enacted as part of the statute in 1938), which, among other things, denounces the doing of certain acts or "any other act" with respect to a food, drug, device, or cosmetic, if done "while such article is held for sale after shipment in interstate commerce" and if it results in such article being misbranded. Since the introduction of S. 1190 and its companion bills, the rendition of certain judicial decisions and the passage of relevant House legislation has created a somewhat different situation for consideration by your committee. As fully explained in this Agency's letters of April 17, 1947, the purpose of the amendments proposed by us and subsequently embodied in S. 1190 and its companion bills was to counteract the effect of the decision of the Ninth Circuit Court of Appeals in United States v. Phelps-Dodge Mercantile Co. ((1946), 157 F. (2d) 453) which had held that the statute did not authorize seizure and condemnation of a food which became contaminated while stored in a warehouse where it had been placed after its interstate journey. The proposed amendment, as explained in AMEND SECTIONS OF FEDERAL FOOD, DRUG, AND COSMÉTIC ACT 9 our letters, would preclude frustration of the original congressional intent. Before further action was taken on these bills, however, the Circuit Court of Appeals for the Fifth Circuit, on May 12, 1947, handed down a decision (United States v. Sullivan, 161 F. (2d) 629) which held that the phrase in section 301 (k) of the act, "while held for sale after shipment in interstate commerce," applied only to the first sale; that is, to the holding for sale by the original interstate consignee. The court cast some doubt on the constitutional power of Congress to exercise control over articles which had been shipped in interstate commerce after they had left the hands of the original interstate consignce. In view of that decision it was felt that it would be desirable to delineate more clearly the area which the proposed amendment to section 304 (a) was designed to encompass and also to clarify section 301 (k) in this respect. At the same time it was considered desirable to make section 301 (k) coextensive with section 304 (a) by making it applicable to acts resulting in adulteration as well as acts resulting in misbranding. This question was discussed at the hearing before subcommittee of the House Committee on Interstate and Foreign Commerce. (See record of hearing of June 12, 1947, on H. R. 3128 and H. R. 3147.) As a result a new bill was introduced in the House (H. R. 4071), which amended section 301 (k) by inserting after the words "while held for sale" the parenthetical phrase "(whether or not the first sale)” and inserting the words "adulterated or" before the word "misbranded" at the end of the subsection, and amended section 304 (a) by authorizing seizure of goods which become adulterated or misbranded "while held for sale (whether or not the first sale) after shipment in interstate commerce.' The House committee reported this bill favorably (H. Rept. No. 807, July 8, 1947) and the House passed this bill on January 13, 1948. On petition of the Government the Supreme Court reviewed the decision in the Sullivan case and on January 19, 1948, reversed the holding of the Fifth Circuit (16 L. W. 4092), and held that the phrase "while held for sale after shipment in interstate commerce" is not restricted to the first sale. For your convenience a copy of the opinion is enclosed. This holding thus disposes of the legal difficulties created by the Sullivan decision in the administration of section 301 (k). The inclusion of adulteration within the scope of the bill, not involved in the Sullivan ca e, is, however, still desirable, and at the same time the parenthetical insertion of the phrase "(whether or not the first sale)" after "held for sale" would serve to make express what has heretofore been left to interpretation. The amendment to section 304 (a) which the bill would make is still necessary to counteract the Phelps-Dodge decision and would, moreover, make the two sections clearly coextensive. The Supreme Court also set at rest any doubts as to the constitutional power of Congress to regulate activities beyond the original interstate consignee. The Court, in holding that the exercise of power as expressed in section 301 (k) was constitutional, reiied on McDermott v. Wisconsin (228 U. S. 115), decided under the Food and Drugs Act of 1906. In comparing the McDermott case with the case at bar, the Court said: "In both cases alike the questions relate to the constitutional power of Congress under the commerce clause to regulate the branding of articles that have completed an interstate shipment and are being held for future sales in purely local or intrastate commerce. The reasons given for the McDermott holding are therefore equally applicable and persuasive here." In the light of the above, we would suggest that, notwithstanding the decision of the Supreme Court in the Sullivan case, your committee give favorable consideration to H. R. 4071 in the form in which it passed the House of Representatives. The Bureau of the Budget advises that there is no objection to the submission of this report to your committee. Sincerely yours, Administrator. HOD. WALLACE H. WHITE, Jr., FEDERAL TRADE COMMISSION, Washington, D. C., February 25, 1948. Chairman, Committee on Interstate and Foreign Commerce, United States Senate, Washington, D. C. MY DEAR MR. CHAIRMAN: In response to a letter from your committee dated January 15, relative to H. R. 4071, Eightieth Congress, second session, entitled, "An act to amend sections 301 (k) and 304 (a) of the Federal Food, Drug, and Cosmetic Act, as amended," which passed the House of Representatives on |