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Biotechnology Regulations and Ethics

FDA Regulation of Probiotics

One of the most significant implications of the Human microbiome project (HMP) is the expansion of number of probiotic products available on the commercial market. As, it is new area of study, new claims are being made about the role and the value of probiotics in promoting human health and well-being. However there is some uncertainty about the how these products should be regulated. The Goal of this paper is to discuss the current legal and regulatory issues raised by probiotics and to determine whether the current regulatory framework is a good fit for the products that are available on the market which may be developed in the future as a result of HMP. This paper discusses the current regulatory structure of probiotics, issues, concerns and broad recommendations.

According to the Joint Food and Agriculture Organization/World Health Working group, probiotics are defined as “live microorganisms which, when administered in adequate amounts, confer a health benefit in the host”. However no legal definition of probiotics exists, in the U.S or in other countries which allows the marketing of products labelled as “probiotics” that do not meet the fundamental criteria stipulated in the scientific definition. Probiotics are live nonpathogenic microorganisms administered to improve microbial balance, particularly in the gastrointestinal tract. They consists of Saccaromyces boulardii yeast or lactic acid bacteria, such as Lactobacillis and Bifidobacterium species, and are regulated as dietary supplements and foods. There are available commercially in many products but primarily as foods and dietary supplements. However a wider variety of probiotic strains, either singly or in combination, is used in supplements than in foods. Supplement formulations may also contain other active…...

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