With this understanding of a normal microbiome as the basis, researchers around the world, including many supported by NIH, are now exploring the links between changes in the microbiome and various diseases.
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The Human Microbiome Project, supported by the National Institutes of Health (NIH) from 2007 to 2016, played a key role in this research by mapping the normal bacteria that live in and on the healthy human body. The community of microorganisms that lives on us and in us is called the “microbiome,” and it’s a hot topic for research. It must be proven safe and effective for its intended use through clinical trials and be approved by the FDA before it can be sold. If a probiotic is going to be marketed as a drug for treatment of a disease or disorder, it has to meet stricter requirements. Dietary supplement labels may make claims about how the product affects the structure or function of the body without FDA approval, but they aren’t allowed to make health claims, such as saying the supplement lowers your risk of getting a disease, without the FDA’s consent.
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Many probiotics are sold as dietary supplements, which don’t require FDA approval before they are marketed. Food and Drug Administration (FDA) might regulate it as a dietary supplement, a food ingredient, or a drug. Depending on a probiotic product’s intended use, the U.S. Government regulation of probiotics in the United States is complex. How are probiotics regulated in the United States?
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What types of bacteria are in probiotics? Many of the microorganisms in probiotic products are the same as or similar to microorganisms that naturally live in our bodies. Some bacteria help digest food, destroy disease-causing cells, or produce vitamins. They can be found in yogurt and other fermented foods, dietary supplements, and beauty products.Īlthough people often think of bacteria and other microorganisms as harmful “germs,” many are actually helpful. Probiotics are live microorganisms that are intended to have health benefits when consumed or applied to the body.