title: Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.
abstract: OBJECTIVE
  Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized.
  
  
  METHODS
  FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm.
  
  
  RESULTS
  A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine.
  
  
  CONCLUSIONS
  Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant.
authors.affiliation: Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE. andrewabe@ku.edu.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Abe
authors.affiliation: Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE.
authors.forename: Darren J
authors.initials: DJ
authors.lastname: Hein
authors.affiliation: Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Gregory
mesh_terms: D002170:Canada; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D019587:Dietary Supplements / Q000706:statistics & numerical data*; D004340:Drug Contamination / Q000706:statistics & numerical data; D004349:Drug Packaging; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*