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Journal of the American College of Nutrition, Vol. 27, No. 6, 659-666 (2008)
Published by the American College of Nutrition

REVIEW

Differences between Dietary Supplement and Prescription Drug Omega-3 Fatty Acid Formulations: A Legislative and Regulatory Perspective

Nancy Collins, PhD, RD, LD/N, Ann P. Tighe, PhD, RD, Stephen A. Brunton, MD and Penny M. Kris-Etherton, PhD, RD

RD411.com, Inc., Weston, Florida (N.C.)
Scientiae, New York, New York (A.P.T.)
Cabarrus Family Medicine Residency, Concord, North Carolina (S.A.B.)
Penn State University, University Park, Pennsylvania (P.M.K.-E.)

Address reprint requests to: Dr. Penny M. Kris-Etherton, Distinguished Professor of Nutrition, Department of Nutritional Sciences, 319 Chandlee Labs, Penn State University, University Park, PA 16802. E-mail: pmk3{at}psu.edu

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.

Key words: Omega-3 fatty acids, LOVAZA®, Food and Drug Administration, dietary supplements, Good Manufacturing Practices, Dietary Supplement Health and Education Act of 1994 (DSHEA)

Abbreviations: AHA = American Heart Association • DART = diet and reinfarction trial • DHA = docosahexaenoic acid • DSHEA = Dietary Supplement Health and Education Act of 1994 • EPA = eicosapentaenoic acid • FD&C = Food, Drug, and Cosmetic Act • GMPs = FDA's Good Manufacturing Practices • IND = investigational new drug • IRBs = institutional review boards • PhRMA=Pharmaceutical Research and Manufacturers of America • USP = United States Pharmacopeial Convention, Inc






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