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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