title: Lead in pharmaceutical products and dietary supplements.
abstract: The objective of this study is to determine lead concentrations in a variety of widely used pharmaceutical products, and to assess the risk of lead exposure from using these products. Lead concentrations of 45 products were measured with inductively-coupled plasma mass spectrometry. Six products had lead concentrations greater than 100 parts per billion (ppb), and the highest measured concentration was 500 ppb. The average mass of lead delivered to consumers by all products examined in this study when taken as directed was 0.22 micrograms per day, which is expected to increase the blood lead level of an adult by less than 1%. Five products were found to deliver more than 1 microg of lead per day when used as directed. Current tolerable lead limits in pharmaceutical substances vary widely, and in some cases exceed 10,000 ppb. The products examined in this study have lead concentrations far below these levels. However, in light of recent research demonstrating adverse effects in both children and adults from low level lead exposure, current lead limits for pharmaceutical substances are unacceptably high. Uniform lead limits that reflect current manufacturing capabilities are needed to insure the lowest achievable exposure to lead from these products.
authors.affiliation: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences, Division of Pharmaceutical Analysis, 1114 Market St., St. Louis, MO 63101, USA. John.Kauffman@fda.hhs.gov
authors.forename: John F
authors.initials: JF
authors.lastname: Kauffman
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Westenberger
authors.forename: J David
authors.initials: JD
authors.lastname: Robertson
authors.forename: James
authors.initials: J
authors.lastname: Guthrie
authors.forename: Abigail
authors.initials: A
authors.lastname: Jacobs
authors.forename: Susan K
authors.initials: SK
authors.lastname: Cummins
mesh_terms: D000328:Adult; D002648:Child; D003257:Consumer Product Safety; D019587:Dietary Supplements / Q000592:standards*; D004340:Drug Contamination; D005506:Food Contamination / Q000032:analysis*; D006801:Humans; D007854:Lead / Q000032:analysis* / Q000633:toxicity; D013058:Mass Spectrometry; D008452:Maximum Allowable Concentration; D018570:Risk Assessment
chemical_list: D007854:Lead