Under the authority of an Act of Congress, approved July 1, 1902, the Public Health Service maintains a supervision over the manufacture and interstate sale of viruses, serums, toxins and analogous products. In accordance with the provisions of this act, regulations have been promulgated in regard to the licensing, inspection and examination of the products, and also for the suspension or revocation of the licenses of those engaged in the production of biologic preparations for sale in interstate commerce or for importation into the United States.
While the law conveys very broad powers in respect to the supervision of manufacturers and their products and permits restriction of the interstate sale of evidently harmful articles of this kind, it does not give specific authority to refuse to issue a license for a product of unknown or doubtful therapeutic value. The possible abuses that may arise because of this omission are so
ANDERSON JF. FEDERAL CONTROL OVER THE MANUFACTURE OF SERUMS AND VACCINES. JAMA. 1913;61(9):659-661. doi:10.1001/jama.1913.04350090027009