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Report Recommends FDA to Regulate Probiotics

Update Date: Oct 17, 2013 02:15 PM EDT
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Probiotics are bacteria that assist in creating a natural balance of organisms living in the intestines. People usually take probiotic supplements for regulating stomach health. Even though probiotics are supposed to do just that, a new article written by Diane Hoffmann, JD, director of the Law and Health Care Program at the University of Maryland Francis King Carey School of Law and colleagues believe that the U.S. Food and Drug Administration (FDA) should regulate and market probiotics.

Due to the fact that the FDA does not regulate how probiotics should be used, Hoffmann, along with faculty members from the University of Maryland School of Medicine's Institute for Genomics Sciences, the University of Maryland School of Pharmacy and the University of Maryland Carey School of Law gathered a group of scientists, legal academics, food and drug law attorneys, government representative, bioethicists and consumer advocates to research probiotics. They focused on whether the current regulations account for any risks involved with taking probiotics, the effectiveness of probiotics and the flexibility of researching new probiotic products.

This type of research article started after the researches were given a three-year grant from the National Institutes of Health (NIH). The study was created to be a part of the Ethical, Legal and Social Issues (ELSI) section to the Human Microbiome Project. The Human Microbiome Project helped increased interest in using probiotics to improve health and diseases.

"There is confusion about the regulatory process, in particular knowing within which product category different types of probiotics fall, and the current regulatory framework discourages the development of probiotic food in preventing disease, improving health, or possibly treating disease," commented professor of microbiology and immunology Jacques Ravel, Ph.D.

In the new article, the research team concluded that the FDA should consider altering the way it currently characterizes probiotics. Currently, numerous food products and supplements market themselves as probiotics that can improve health even though the FDA has never approved any therapeutic effects of probiotics that these products are stating. The report recommends the FDA to take an "abbreviated" process for a select few probiotic products, which would allow these products to skip phase I trials and go straight into clinical testing. The products the report included were probiotic foods, dietary supplements and dietary ingredients that have been deemed sage to use.

The report, "Probiotics: Finding the Right Regulatory Balance," was published in Science.

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