Regulatory alerts for dietary supplements in Canada and the United States, 2005-13

Andrew M. Abe, Darren J. Hein, Philip J. Gregory

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Purpose. 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. Conclusion. 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.

Original languageEnglish (US)
Pages (from-to)966-971
Number of pages6
JournalAmerican Journal of Health-System Pharmacy
Volume72
Issue number11
DOIs
StatePublished - Jun 1 2015

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Dietary Supplements
Canada
United States Food and Drug Administration
Patient Harm
Athletic Performance
sibutramine
Health
Weight Loss
Phosphodiesterase 5 Inhibitors
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Health Policy

Cite this

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13. / Abe, Andrew M.; Hein, Darren J.; Gregory, Philip J.

In: American Journal of Health-System Pharmacy, Vol. 72, No. 11, 01.06.2015, p. 966-971.

Research output: Contribution to journalArticle

Abe, Andrew M. ; Hein, Darren J. ; Gregory, Philip J. / Regulatory alerts for dietary supplements in Canada and the United States, 2005-13. In: American Journal of Health-System Pharmacy. 2015 ; Vol. 72, No. 11. pp. 966-971.
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abstract = "Purpose. 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. Conclusion. 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.",
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