Why doesn the FDA recall all thimerosal-containing vaccines intended for use in infants and small children?
A. A recall of thimerosal-containing vaccines is not warranted because currently, available data show that these products are safe and effective. Federal law is specific about the criteria that must be met before FDA can enforce a mandatory recall of a regulated product. Under section 351(d) of the Public Health Service Act, a licensed vaccine (or other biological product) shall be recalled if FDA determines that it “presents an imminent or substantial hazard to the public health…” FDA does not believe that thimerosal-containing vaccines present an imminent or substantial hazard to the public health because available scientific data do not establish that exposure to thimerosal in vaccines can cause neurodevelopmental disorders. Additional studies on the potential for adverse effects of mercury in vaccines are continuing. Results of these studies will be closely monitored. FDA regulations also provide for a voluntary recall of products regulated by the FDA (21 CFR, Part 7). A firm may
