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Review
. 2023 Feb:89:101103.
doi: 10.1016/j.mam.2022.101103. Epub 2022 Jul 17.

Have safety and efficacy assessments of bioactives come of age?

Johanna T Dwyer  1
Affiliations
Review

Have safety and efficacy assessments of bioactives come of age?

Johanna T Dwyer. Mol Aspects Med. 2023 Feb.

Abstract

This article describes why the safety and efficacy assessment of non-nutrient bioactives for reducing chronic disease risk is so complicated, especially for dietary supplements and traditional medicines. Scientists, regulators, and the public have different and sometimes opposing perspectives about bioactives. Drug, food, and traditional medicine models used for bioactive safety assessment are based on different assumptions and use different processes. Efficacy assessment is seldom based on clinical trials of boactives' effects in reducing chronic disease risk. It usually consists of application of quality assurance measures and evaluation of label claims and commercial speech about ingredients or products to ensure conformity to regulations. Harmonization of safety and efficacy assessment on a global basis is difficult because of differences within and between regulatory systems. The recommendations provided may open the way for bioactives to play a larger health role in the future, fill gaps in data needed for crafting authoritative dietary guidance on intakes, and speed harmonization of global standards.

Keywords: Bioactives; Dietary recommendations; Effectiveness; Functional ingredients; Nutraceuticals; Policy; Regulation; Safety.

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Conflict of interest statement

Declaration of competing interest Dr. Dwyer is Senior Nutrition Scientist (contractor) at the Office of Dietary Supplements, National Institutes of Health, and Senior Scientist, Senior Scientist at the Jean Mayer USDA Human Nutrition Research Center and a Professor at the School of Medicine, Tufts University. She is editor-in-chief of the journal Nutrition Today. She is a member of the Scientific Advisory Board of the McCormick Science Institute, the Mushroom Council, and Bay State Milling Inc, and the *STAR Singapore Institute of Science and Technology is a nonpaid advisor to a committee of the Institute of Food and Nutrition Science (IFANS) and chair of the governance committee of the International Life Sciences(ILSI) US-Canada Research Program. She holds stock in several food and drug companies and was a one-time consultant to Nestle Inc., in 2020, on an issue unrelated to the content of this article and holds no grants or contracts.

Figures

Figure 1
Figure 1
Different Regulatory Categories into which Bioactives are Placed in various countries
Figure 2
Figure 2
Framework for Developing Recommended Intakes of Bioactive Dietary Substances in Foods (courtesy of IFANS).
See this image and copyright information in PMC

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