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The Use of Radioisotopes Under Federal Food and Drug Laws
The Use of Radioisotopes
Und
The peacetime, civilian uses of radioisotopes by the biological industries warrant our closest atterz,tion-and control-according to Mr. Rankin, in this address first delivered at Oak Ridge, Tenn., April 28, 1903.
BY
w.
B. RANKIN
Assistant Director, Division of Field Operations. Food and Drug Administration, U.S. Department of Health, Education, and Welfare
ago the United States was engaged N in an intensive search for defensive measures OT LONG
which would protect the food and drug supply of the Nation in the event of atomic attack. This has yielded reasonably satisfactory test procedures for beta-gamma contamination following an atomic burst. Now is the time to consider the peacetime, civilian uses of radioisotopes by the biological industries. Radioisotopes have been available for a long time in the form of uranium, radium, and related, naturally occurring materials. X-rays have had their place in medicine and industry for years. N either isotopes nor radiations were present in sufficient quantity, however, to suggest that they might be employed in volume in biological industries. This is changed today. Millions of curies of radioactivity are produced by the nuclear reactors, both intentionalJy and as by-products. Very properly the Atomic Energy Commission sponsors studies to determine what worthwhile use can be made of vast stores of waste products from the atomic piles. What is the role of the Food and Drug Administration in this search for profitable civilian applications of atomic energy? 556
The Role of the FDA
The administration enforces the Federal Food, Drug, and Cosmetic Act, which regulates interstate commerce in food, drugs, devices and cosmetics. The Act safeguards the consumer by requiring these products to be pure, wholesome and safe. Although it does not specifically provide for the Administration to sponsor research to develop outl~ts or uses for new processes or tools such as atomic energy, the Administratign does work with industry as such technological advancements come along, so that the maximum benefit may be realized from them consistent with sound consumer protection. Many st~tes have comparable food and drug laws which apply to intrastate traffic as the Federal Act applies to interstate traffic. Let us define radioactivity, from the standpoint of the law, before trying to decide what the law requires of it. Remember that radioactivity is harmful to living material. Even small amounts of radiation are injurious to plant and animal cells. Radiation is a poison. Radioisotopes are poisons not only because, many of them are heavy metals but also because their radiations are toxic. Vol. XIV, No.9
~deral
Food and Drug Laws
Are these potentially useful tools to be barred then from food and drug manufacturing because they are poisons? Not at all. Other poisons are used by biological industries with real benefit to agriculture, industry, and the consumer. It is essential, though, to determine carefully what safeguards must be placed around the use of radioisotopes in the interest of the consuming public. Other more common poisons are used only where necessary and then so that the use dots not endanger the consumer. For example, insecticides containing lead, arsenic, fluorides, organic chlorides, and more recently the organic phosphates are used widely in agriculture. However, their commercial use must be preceded by careful research which shows the conditions under which the material may be employed with safety. Similarly, the biological industries have an obligation to conduct the same sort of fundamental study and research before employing radioisotopes or radiations cOlnmercially. The food and drug law enforcement official is concerned with the employment of a radioisotope: 1. 2. 3. 4. 5.
As a drug As a device In a cosmetic In a food For sterilizing food or drugs
A radioisotope intended for or used as a drug is a "new drug" under the law. The Act provides that a new drug shall be distributed in interstate commerce for general therapeutic use only after its safety for such use has been established by carefully controlled tests under the supervision of experts qualified to make such determinations. When the tests have been made, the evidence of safety should be submitted to the Department of Health, Education, and Welt'are as a "new drug application." Only after the application becomes effective, is the manufacturer of the new drug privileged to ship it freely in interstate commerce. Septemb~r,
1953
Obviously, there is legitimate need for some new drugs to be shipped interstate for use in investigations to establish their safety. One section of the Act, Section 505 (i), and the regulations developed under it, specify the manner in which new drugs may be distributed to experts for such investigations.
Atomic energy research goes forward in buildings such as this at Oak Ridge, Tenn.
Radioisotopes are shipped in interstate commerce today under effective new drug applications. One firm is producing and distributing material quantities of iodine 131 to be used in the study and treatment of certain thyroid disorders. As the safety of other therapeutic uses of radioisotopes is established, through the new drug procedure, general distribution of the drugs will be sanctioned by the Department. The Schemers
Radioisotopes also may be employed in therapeutic devices. When so employed with adequate directions for their use and precautions (Continued on page 600)
557
Und
The peacetime, civilian uses of radioisotopes by the biological industries warrant our closest atterz,tion-and control-according to Mr. Rankin, in this address first delivered at Oak Ridge, Tenn., April 28, 1903.
BY
w.
B. RANKIN
Assistant Director, Division of Field Operations. Food and Drug Administration, U.S. Department of Health, Education, and Welfare
ago the United States was engaged N in an intensive search for defensive measures OT LONG
which would protect the food and drug supply of the Nation in the event of atomic attack. This has yielded reasonably satisfactory test procedures for beta-gamma contamination following an atomic burst. Now is the time to consider the peacetime, civilian uses of radioisotopes by the biological industries. Radioisotopes have been available for a long time in the form of uranium, radium, and related, naturally occurring materials. X-rays have had their place in medicine and industry for years. N either isotopes nor radiations were present in sufficient quantity, however, to suggest that they might be employed in volume in biological industries. This is changed today. Millions of curies of radioactivity are produced by the nuclear reactors, both intentionalJy and as by-products. Very properly the Atomic Energy Commission sponsors studies to determine what worthwhile use can be made of vast stores of waste products from the atomic piles. What is the role of the Food and Drug Administration in this search for profitable civilian applications of atomic energy? 556
The Role of the FDA
The administration enforces the Federal Food, Drug, and Cosmetic Act, which regulates interstate commerce in food, drugs, devices and cosmetics. The Act safeguards the consumer by requiring these products to be pure, wholesome and safe. Although it does not specifically provide for the Administration to sponsor research to develop outl~ts or uses for new processes or tools such as atomic energy, the Administratign does work with industry as such technological advancements come along, so that the maximum benefit may be realized from them consistent with sound consumer protection. Many st~tes have comparable food and drug laws which apply to intrastate traffic as the Federal Act applies to interstate traffic. Let us define radioactivity, from the standpoint of the law, before trying to decide what the law requires of it. Remember that radioactivity is harmful to living material. Even small amounts of radiation are injurious to plant and animal cells. Radiation is a poison. Radioisotopes are poisons not only because, many of them are heavy metals but also because their radiations are toxic. Vol. XIV, No.9
~deral
Food and Drug Laws
Are these potentially useful tools to be barred then from food and drug manufacturing because they are poisons? Not at all. Other poisons are used by biological industries with real benefit to agriculture, industry, and the consumer. It is essential, though, to determine carefully what safeguards must be placed around the use of radioisotopes in the interest of the consuming public. Other more common poisons are used only where necessary and then so that the use dots not endanger the consumer. For example, insecticides containing lead, arsenic, fluorides, organic chlorides, and more recently the organic phosphates are used widely in agriculture. However, their commercial use must be preceded by careful research which shows the conditions under which the material may be employed with safety. Similarly, the biological industries have an obligation to conduct the same sort of fundamental study and research before employing radioisotopes or radiations cOlnmercially. The food and drug law enforcement official is concerned with the employment of a radioisotope: 1. 2. 3. 4. 5.
As a drug As a device In a cosmetic In a food For sterilizing food or drugs
A radioisotope intended for or used as a drug is a "new drug" under the law. The Act provides that a new drug shall be distributed in interstate commerce for general therapeutic use only after its safety for such use has been established by carefully controlled tests under the supervision of experts qualified to make such determinations. When the tests have been made, the evidence of safety should be submitted to the Department of Health, Education, and Welt'are as a "new drug application." Only after the application becomes effective, is the manufacturer of the new drug privileged to ship it freely in interstate commerce. Septemb~r,
1953
Obviously, there is legitimate need for some new drugs to be shipped interstate for use in investigations to establish their safety. One section of the Act, Section 505 (i), and the regulations developed under it, specify the manner in which new drugs may be distributed to experts for such investigations.
Atomic energy research goes forward in buildings such as this at Oak Ridge, Tenn.
Radioisotopes are shipped in interstate commerce today under effective new drug applications. One firm is producing and distributing material quantities of iodine 131 to be used in the study and treatment of certain thyroid disorders. As the safety of other therapeutic uses of radioisotopes is established, through the new drug procedure, general distribution of the drugs will be sanctioned by the Department. The Schemers
Radioisotopes also may be employed in therapeutic devices. When so employed with adequate directions for their use and precautions (Continued on page 600)
557