title: Quality of manufacturer provided information on safety and efficacy claims for dietary supplements for colonic health.
abstract: OBJECTIVE
  Food and Drug Administration (FDA) approval of dietary supplements is not required. However, manufacturers must ensure that data exist to support safety and efficacy claims of their product. This study was designed to evaluate accessibility and quality of such data from manufacturers of dietary supplements for 'colonic health.'
  
  
  METHODS
  Supplements promoting 'colonic health' were identified at area stores. A physician contacted the manufacturers by mail and telephone requesting data to substantiate claims of efficacy and safety. MEDLINE was searched to identify reports of adverse events or medication interactions.
  
  
  RESULTS
  Twelve manufacturers of 23 products were surveyed. Eight manufacturers responded, of whom four provided no clinical data to substantiate claims of efficacy or safety. No manufacturer provided data that directly evaluated their product. Our literature review identified a wide range of potential adverse events and drug-supplement interactions, albeit mostly as case reports, animal studies, or in vitro experiments.
  
  
  CONCLUSIONS
  There is a need to increase availability of supplement safety data to physicians and the general public. Consideration should be given to various responses, including legislative actions that address this issue.
authors.affiliation: Department of Medicine, Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hass
authors.forename: James D
authors.initials: JD
authors.lastname: Lewis
mesh_terms: D003108:Colonic Diseases / Q000517:prevention & control*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D003625:Data Collection; D019587:Dietary Supplements / Q000009:adverse effects* / Q000592:standards; D004347:Drug Interactions; D019649:Food Industry / Q000331:legislation & jurisprudence / Q000592:standards; D029001:Herbal Medicine; D007881:Legislation, Food; D010946:Plants, Medicinal / Q000009:adverse effects; D016896:Treatment Outcome