In 1943, the War Production Board requested the Food and Drug Administration to assay samples of each batch of penicillin then being produced for use by the armed forces. In 1945, shortly before penicillin was to be made available for use in the civilian sector, Congress amended the 1938 Act by adding a section calling for the batch certification of penicillin products. This section of the Federal Food, Drug and Cosmetic Act has since been amended three times. In 1947, the batch certification requirements were extended to streptomycin. In 1949, Congress amended the antibiotics section of the law (Sec. 507) to include chloretracycline, bacitracin, chloramphenicol, and their derivatives. The Drug Amendments of 1962 extended the batch certification requirements to all antibiotics intended for use in man.8 V. REGULATORY AMENDMENTS OF 1948 In 1948, the Federal Food, Drug, and Cosmetic Act was amended to clarify the extent of the FDA's regulatory authority. The Act, based on the commerce clause of the Constitution, was intended to exclude from interstate commerce articles that are misbranded or adulterated. However, a number of court decisions raised the question, "where did interstate commerce begin and where did it end?" Enforcement officials were of the opinion it went all the way from the producer in one state to the consumer in another. In one of the cases raising this issue, the FDA instituted seizure of macaroni and spaghetti which had become contaminated while stored in a mining company warehouse. The goods were condemned and the claimant appealed. The court of appeals ruled that the food had ended its interstate journey when the adulteration occurred. The Supreme Court declined to review the decision." Congress was immediately asked to close this loophole in the law. The new legislation, also known as the Miller Amendment, after its principal sponsor, A. I. Miller, Representative from Nebraska, clearly gave the Government jurisdiction over products that became adulterated or misbranded after interstate shipment and at all levels of distribution, including retailing.' 10 VI. THE DELANEY COMMITTEE During the 1940's there was a substantial increase in the use of commercial pesticide chemicals, such as DDT, in the growing of raw agricultural products and in the use of chemical substances for flavoring, preserving, and packaging of standardized foods. In June of 1950, the House of Representatives adopted a resolution creating a Select Committee to Investigate the Use of Chemicals in Foods. The Select Committee was also known as the "Delaney Committee", after its chairman, Representative James J. Delaney of New York. The Committee began extensive hearings into the matter of pesticides and food additives during 1950, and as a result of a second Resolution 559 Stat. 462, 79th Cong., 1st sess.; July 6, 1945. 661 Stat. 11. 80th Cong., 1st sess.; Mar. 10, 1947. 763 Stat. 409, 81st Cong., 1st sess.; July 13, 1949. 8 76 Stat. 780, 87th Cong., 2d sess.: Oct. 10. 1962. 9 United States v. Phelps Dodge Mercantile Co., 157 F. 2d 453 (1946), cert. denied, 330 U.S. 818 (1947). 10 62 Stat. 582, 80th Cong., 2d sess.; June 24, 1948. extended its investigation through the 82nd Congress as well." Hearings were terminated a few months later in March 1952 and the Select Committee published its findings a few months later in four reports covering fertilizers, cosmetics, food and fluoridation. The third report of the Delaney Committee, entitled "Food", specifically recommended that chemicals used in or on foods be tested to establish their safety prior to their use in foods.12 Although Congress did not immediately enact legislation following publication of the Select Committee's reports, it is generally conceded that these reports and the hearings of the Committee had an important influence on the shape of the pesticide legislation in 1954, the food additives legislation of 1958, and the color additive amendments of 1960. VII. THE DURHAM-HUMPHREY AMENDMENT OF 1951 In 1951, the Congress passed another amendment to the Federal Food, Drug, and Cosmetic Act, popularly known as the DurhamHumphrey Amendment after the names of its sponsors.13 The statute contains a legal definition of the kinds of drugs for human use which may be dispensed by the pharmacist only upon the prescription of a "practitioner licensed by law to administer such drugs." Thus it leaves to State medical practice laws and medical practice boards to determine who is qualified to prescribe drugs, just as State pharmacy laws and boards determine who is qualified to dispense drugs. Under the amendment, it is unlawful to dispense a drug bearing the Rx Legend without a prescription or to refill a prescription for an Rx Legend drug without an authorization from the prescriber. The amendment is grounded in the principle that the physician should control the amount of medication given to his patients. A prescription or refill may be transmitted by telephone, but such authorizations must be promptly reduced to writing and be filed by the pharmacist. Certain narcotic drugs can only be dispensed upon written order of the practitioner. The law further required that prescription-restricted drugs be labeled with the Rx Legend, and that it is illegal to place this legend on drugs not so restricted. The fundamental purpose of the legislation was to provide the pharmacist with clear guidance as to which drugs may not be sold, or refilled, without a prescriber's authorization, as distinguished from those products which may be sold to the layman for self-medication (known as over-the-counter, or OTC drugs). The Durham-Humphrey Amendment defined three categories of prescription drugs: hypnotic or habit-forming drugs that are specifically named in the law, and their derivatives, unless specifically exempted by regulation; a drug which is not safe for self-medication "because of its toxicity or other potentiality for harmful effect, or the method of use, or collateral measures necessary to its use"; 11 "Chemicals in Food Products," Hearing before the House Select Committee to Investigate the Use of Chemicals in Food Products, 81st Cong., 2d sess.; created pursuant to House Resolution 323 (1 vol.); also, "Chemicals in Food Products," 82d Cong., 1st and 2d sess.: pursuant to House Resolutions 74 and 447 (4 vols.); 1950-52. 12 "Foods," H. Rept. No. 2356; 82d Cong., 2d sess.; June 30, 1952. 13 65 Stat. 648, 82d Cong., 1st sess.; Oct. 26, 1951. and a "new drug" which has not been shown safe for use in self-medication, and which, under the terms of an effective new-drug application, is limited to prescription dispensing. Many drugs which are considered "safe," insofar as their inherent toxicity is concerned, must be restricted to prescription sale because of the conditions for which they are intended to be used, because of diagnostic techniques, or because of collateral therapeutic techniques which are required in connection with their use. În brief, the Rx Legend drugs are not safe enough for a layman to use in self-medication. The labels on such drugs do not, therefore, contain detailed directions for use, precautions, and so forth, which would be needed by the layman to use the drugs safely and effectively. The physician and the pharmacist, however, must be provided with such information and the Amendment requires that that manufacturer provide them with such data. Drugs which are not restricted to prescription sale (over-the-counter-drugs) must bear adequate directions for safe and effective use and warnings against misuse which the layman needs to know. The distributor of OTC drugs is required by law to label the product with such information. Drugs which may legally be sold over-thecounter must bear a "7-point label:" 1. the name of the product. 2. the name and address of the manufacturer, packer, or distributor. 3. the net contents of the package. 4. the established name of all active ingredients and the quantity of certain other ingredients whether active or not. 5. the name of any habit-forming drug contained in the preparation. 6. cautions and warnings needed for the protection of the user. 7. adequate directions for safe and effective use. Typical warnings tell how to use the medication safely-"Do not apply to broken skin;" when not to use the medication-"Do not drive or operate machinery;" and when to stop taking the drug-"Discontinue use if rapid pulse, dizziness, or blurring of vision occurs." Other warning statements answer questions for the layman, such as whether he should see a physician-"If pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately." Any drug which does not bear the Rx Legend can be sold without a prescription, and the consumer has the responsibility for reading and heeding the directions and warnings. VIII. FACTORY INSPECTION AMENDMENTS OF 1953 14 In 1952, the Supreme Court held that the 1938 Act did not clearly permit mandatory factory inspection. One section of the Act made it a criminal offense to refuse permission to inspect. However, another section provided that a factory could be inspected only with permission. of the operator. The Court found these two sections to be "fatally inconsistent." 14 United States v. Cardiff, 344 U.S. 174. As a result of the Supreme Court ruling, Congress passed an amendment in 1953 to permit the FDA inspection, after written notice to the owner, without a warrant and without permission of the owner.15 Although the mandatory inspection provision was passed, the legislative history developed during the floor debate on the bill made it clear that inspection should not include access to records other than shipping records and that inspectors should not be allowed to check formula cards, complaints files, personnel records, or prescription files. Although the 1953 Amendment authorized factory inspection without a warrant, the Supreme Court held in 1967 that a business proprietor can refuse to admit a government inspector unless he has a search warrant. This decision led the FDA to issue guidelines for obtaining a warrant when an owner or manager refused to consent to inspection voluntarily. IX. FOOD STANDARD AMENDMENTS OF 1954 In 1954, the Food, Drug, and Cosmetic Act was amended to simplify the procedure for establishing standards of identity, quality and fill of containers for foods. The existing law required a formal hearing upon any proposal to issue, amend, or repeal regulations regarding several sections of the Act, including definitions and standards for foods. The Amendment eliminated the requirement for a formal hearing when there was no controversy over the proposed rule.16 X. THE PESTICIDE CHEMICAL AMENDMENT OF 1954 In 1954, Congress passed the Pesticide Chemical Amendment to the Federal Food, Drug, and Cosmetic Act, sometimes known as the "Miller Act", after its principal sponsor, A. I. Miller, Representative from Nebraska." The amendment was designed to provide a new, more effective procedure for controlling the residues of pesticide chemicals used in connection with the growing of raw agricultural commodities. Under the provisions of the 1938 Act, food which contained chemical residues could be deemed adulterated and prohibited in interstate commerce. However, it was generally acknowledged that the method was slow and inadequate due to the large number of pesticides in use. The Miller Act incorporated a pre-market testing principle advocated by the Delaney Committee in 1952. The procedure used for the pre-market testing made use of the 1947 Insecticide, Fungicide and Rodenticide Act which required a manufacturer to register the label of a pesticide with the Department of Agriculture.18 Under the new amendment to the Food, Drug, and Cosmetic Act, the manufacturer had to obtain from the FDA, prior to registering the label, a "tolerance" for a pesticide to determine how much pesticide chemical might remain on or in the raw agricultural product. The burden for proving that the residue levels were safe was made the responsibility of the manufacturer. If the FDA, on the basis of the scientific data 15 67 Stat. 476, 83d Cong., 1st sess.; Aug. 7, 1953. presented, decided that any amount of residue would be dangerous to health, they could refuse to establish a tolerance level. Consequently, the manufacturer could not register the pesticide with the Department of Agriculture. Any raw agricultural product which had a residue exceeding that set by the FDA was subject to seizure and condemnation by the FDA. The 1954 amendment also provided procedures for determining tolerance levels for pesticides registered prior to enactment of the legislation. The FDA was given the authority to exempt any pesticide chemical from the tolerance requirement when the safety of the consumer was not affected. The FDA no longer has the responsibility for setting tolerance levels for pesticide residues. The President's Reorganization Plan of July 9, 1970, established the Environmental Protection Agency and transferred the function of establishing tolerances from FDA to the new agency. Authority was also transferred for (1) monitoring compliance with the tolerances and the effectiveness of surveillance and enforcement, and (2) providing technical assistance to the States and conducting research under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. XI. ORANGE COLORING AMENDMENT OF 1956 The 1938 Act placed two restrictions on the use of coal-tar dyes: (1) the dye must be found harmless by the FDA, and (2) it must be from a batch certified by the FDA. In 1956, Congress legislated an exception to the requirement of safety. The exception was a dye, FD&C Red No. 32, which was the only coloring suitable for giving certain varieties of ripe oranges the color expected by consumers. This dye was found to be toxic and was subsequently removed from the list of coal-tar dyes approved by the FDA. Without the use of this dye, the orange growers in Florida and Texas expected to suffer great financial loss due to a decrease in the attractiveness of the fresh fruit. Since there was no evidence that the use of the dye in coloring orange peels was harmful, Congress passed a bill to allow such limited use.19 The Committee report on the bill stated that the legislation was to provide time to develop an alternative coloring which would meet the requirements of the 1938 Act regarding coal-tar dyes. XII. FOOD STANDARD AMENDMENTS OF 1956 In 1956, legislation was passed to further simplify the rulemaking process for food standards.20 Amendments in 1954 had eliminated the requirement for formal hearings prior to issuance of standards on identity, quality and fill of container when there was no controversy over the proposal. The new amendment applied this simplified procedure to the regulations on foods for special dietary uses, tolerances for poisonous ingredients, use of emergency permits, and certain other areas requiring rule-making. XIII. THE FOOD ADDITIVES AMENDMENTS OF 1958 A number of bills were introduced into the 83rd, 84th, and 85th Congresses to implement the recommendations of the Delaney Committee. 19 70 Stat. 512, 84th Cong., 2d sess.; July 9, 1956. 20 70 Stat. 919, 84th Cong., 2d sess.; Aug. 1, 1956. |