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February 07, 2017

Mercury in Vaccines

Over-the-counter (OTC) products and vaccines are regulated by different branches of the FDA. OTCs are regulated by the Center for Drug Evaluation and Research (CDER). Vaccines are regulated by the Center for Biologics Evaluation and Research (CBER). The FDA’s determination that mercury was unsafe and should be removed from over-the-counter medications was published in the Federal Register no fewer than five times prior to the FDA’s belated review of mercury in vaccines. What finally prompted the FDA to review mercury in vaccines was not its own regulatory process, but rather an act of Congress. In 1997, Congress passed and the President signed into law, the Food and Drug Administration Modernization Act (FDAMA) of 1997 requiring the study of the “adverse effects on health of children and other sensitive populations from exposure to mercury.” At that time the FDA requested information from the pharmaceutical industry and conducted a review of the use of thimerosal in childhood vaccines.

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