Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: A legislative and regulatory perspective

Nancy Collins, Ann P. Tighe, Stephen A. Brunton, Penny M. Kris-Etherton

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

Abstract

The medical management of many diseases and conditions can include either restriction or provision of specific essential nutrients. When such nutrients are needed, there are often both prescription and nonprescription products available, as in the case of nicotinic acid or omega-3 fatty acids. Although they may seem to contain similar ingredients, there may be important differences between the prescription and dietary-supplement preparations. The manufacturing of prescription pharmaceutical products is regulated by the US Food and Drug Administration (FDA), which mandates standards for consistency and quality assurance. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act of 1994, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturer prove that the supplement is safe. Consumers and medical professionals should be aware of the important qualitative and quantitative differences between the FDA-approved prescription formulations and dietary supplements, particularly when an essential nutrient is part of the medical management of a disease or condition.

Original languageEnglish (US)
Pages (from-to)659-666
Number of pages8
JournalJournal of the American College of Nutrition
Volume27
Issue number6
DOIs
StatePublished - Dec 1 2008

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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