The Biologics Control Act or the Virus Toxin Act, was passed in 1902 after 13 children died in St. Louis from tetanus, which had contaminated the diphtheria antitoxin they had received in 1901. Dr. Joseph J. Kinyoun of Marine Hospital Service’s Hygienic Laboratory (the ancestor of the Division of Biologics Standards [DBS] and the NIH more broadly) recognized the danger posed by the availability of unstandardized and poorly tested diphtheria antitoxins. Kinyoun wanted to establish an independent testing laboratory, however it took an incident in 1901 in St. Louis to get Congress to act, when 13 children who had received the antitoxin died of tetanus. An investigation discovered that one of the horses used in the manufacture of the antitoxin had live tetanus organisms in its blood and was the source of the infection.
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Newspaper clipping from St. Louis Republic on November 2, 1901 with photo of the alleged horse used for diphtheria antitoxin.
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FDA History Office
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Congress then introduced two bills, both enacted on July 1, 1902. One bill established the Public Health and Marine Hospital Service, the other authorized this new service to regulate the sale and transportation of any virus, therapeutic serum, toxin, or analogous product in interstate commerce or from a foreign country. All establishments engaged in the sale, barter, or exchange, or offering for sale, barter, or exchange of biological products in interstate commerce must be licensed, and each product must be licensed individually. Each licensee must be inspected annually by agents and officers of the Federal government. The second act is known as the Biologics Control Act or the Virus-Toxin Act. This act has been amended by Congress several times to incorporate additional product classes, including blood, blood components, and blood derivatives. Today the regulated biologics include vaccines, blood and blood products, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
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An image of the 1902 Biologics Control Act or the Virus Toxin Act.
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The Division of Biologics Standards [Public Health Service Publication No. 1744] by Dr. Roderick Murray published in 1968.
