GAITHERSBERG, MD, Nov. 18 As clinical studies continue to validate the use of probiotics to help promote general gastrointestinal health, a growing U.S. market1 for probiotics indicates that the U.S. healthcare community and consumers alike are recognizing the value of these beneficial microorganisms. However, because most probiotics are classified as dietary supplements, directing patients to the best probiotic for their individual needs can be challenging. And, as the category matures, one probiotic preparation -- VSL#3 -- stands apart and ahead because it is not a supplement; it has been classified as a refrigerated medical food designated for the dietary management of three major gastrointestinal conditions: Ulcerative Colitis, Ileal Pouch and Irritable Bowel Syndrome (IBS).
The World Health Organization (WHO) defines probiotics as "live microorganisms which, when administered in adequate amounts confer a health benefit to the host." But research also shows that probiotics are not "one size fits all."
"As the amount of research in the field of probiotics increases, clinical evidence continues to indicate that not all probiotics are the same; probiotic activity is strain-specific and unique, and some strains can have antagonistic or synergistic activities when mixed together," said Marc Tewey, vice president, commercial operations, at Sigma-Tau Pharmaceuticals, Inc., manufacturer of VSL#3. "VSL#3 is formulated with a precise mix of eight proprietary strains of live bacteria, and the result is a probiotic medical food so potent, it must be used under medical supervision and must be shipped and sold as a refrigerated product."
What are medical foods?
According to the FDA, medical foods are:
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Robin Leedy & Associates, Inc.