INNOVATIONS in pharmacy

A Comparison of Current Regulatory Frameworks for Nutraceuticals in Australia, Canada, Japan, and the United States.

Jessica Blaze

Nova Southeastern University

DOI: https://doi.org/10.24926/iip.v12i2.3694

Keywords: Regulatory framework, regulation, nutraceuticals, Vitamins, minerals, Dietary supplements, Probiotics, Herbal supplements

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Abstract

The nutraceutical market is growing and the demand for products is increasing. Consumers are looking for cheaper alternatives to prescription medications as well as health products to supplement their dietary intake on a regular basis. Many countries classify these products into different categories based on their health claims. The purpose of this review is to compare and contrast the differences of regulatory frameworks in countries of similar status in regard to nutraceutical products: vitamins, minerals, herbal supplements, and probiotics. This review also takes into consideration the aspects of nutraceutical safety in relation to government regulations. It is evident that further discussion is indicated with regard to the harmonization of nutraceutical product regulation in a global context in order to promote and protect public health.

 This literature review selected 27 documents for a review using a systematic search of internet databases and search engines including PUBMED and Google Scholar. These documents were reviewed and synthesized for data relating to nutraceutical regulation within the four different countries of focus. Outcomes included information on safety and toxicity, drug interactions, classification of products, and regulatory processes for nutraceutical product approval in each country.