News Release

VSL#3® passes consumer lab approval test for probiotics

Independent testing organization confirms 8-strain proprietary formulation of live bacteria from Sigma-Tau Pharmaceuticals

Business Announcement

Robin Leedy & Associates, Inc.

GAITHERSBURG, MD, July 8, 2014 – Probiotics have gained in popularity in recent years and consumers now have many to choose from. However, only 14 of 19 successfully tested through Consumer Lab's quality certification program probiotics. VSL#3®, a high potency probiotic medical food for the dietary management of irritable bowel syndrome (IBS), ulcerative colitis, and an ileal pouch, is included on the list. Consumerlab.com is the leading provider of independent test results and information to help consumers and healthcare professionals independently evaluate supplements that affect health, wellness and nutrition. VSL#3 is made in America and distributed by Sigma-Tau Pharmaceuticals, Inc. of Gaithersburg, MD.

"This independent endorsement supports the s VSL#3 claim that the product contains 112.5 to 900 billion live probiotic bacteria, which is essential in delivering enough microorganisms to beneficially affect the gut flora in patients with IBS or UC," says Mary Ocnean, group product director at Sigma-Tau. "The proprietary formulation has also been shown in the dietary management of IBS to reduce abdominal bloating in patients."

The Consumerlab.com report on quality testing was conducted on a randomly-selected group of top probiotic products in the U.S. It included confirmation that the product actually contained the number of live (viable) bacteria listed on the product label, and if there were at least one billion live microorganisms per suggested daily adult serving (the generally accepted minimum amount needed to deliver any significant health benefits). The products were also tested to determine if they were free of contamination from mold or types of bacteria with disease-causing potential. Products like VSL#3 that require cold-shipping were also tested to ensure the presence of the live bacteria.

The report revealed that only 14 of 19 probiotic products actually contained the labeled amounts of live microorganisms and is free of contamination from common "bad" bacteria and mold.

Products were also tested to see that they disintegrated properly (if in tablet form) so that their contents would be released, or if enteric-coated or delayed release, their contents would be released, respectively, after passing through the stomach.

"VSL#3 has been supported by extensive scientific data over the years along with being recognized by prestigious organizations, such as The World Organization of Gastroenterology," says Ocnean. "This validation by a reputable third party offers physicians and healthcare professional's added credibility in recommending VSL#3 to their patients and for consumers to have confidence taking the formulation."

Consumerlabs.com also advises consumers to choose a probiotic that is appropriate for the condition they have and provided a chart indicating which product and probiotic strains were studied in each condition. VSL#3, the testing lab says, shows current evidence for irritable bowel syndrome (IBS).

"IBS is a common problem in adults for which there is no cure," adds Ocnean. "It's a digestive disorder that does not discriminate among adults and children. As a high potency probiotic medical food, VSL#3 contains eight strains of live, freeze-dried lactic acid bacteria from 112.5 to 900 billion live bacteria per serving (depending on which VSL#3 formulation) making it up to 10 times more potent than the average probiotic. By adding VSL#3 to traditional therapies for the dietary management of ulcerative colitis or IBS, patients can help maintain their remission."

All VSL#3 formulations are refrigerated (to preserve potency) and kept behind the counter at pharmacies nationwide. Ask your doctor or pharmacist if VSL#3® is appropriate for you or your child. All forms of VSL#3® are medical foods and must be used under medical supervision.

There are five formulations:

    1. VSL#3 DS available by prescription in sachets/packets containing 900 billion bacteria
    2. VSL#3 packets containing 450 billion bacteria (comes in flavored and unflavored versions)
    3. VSL#3 JUNIOR packets containing 225 billion bacteria
    4. VSL#3 capsules containing 112.5 billion bacteria

All VSL#3 formulations are, gluten free, Kosher and Halal certified. Although they should be refrigerated when stored, VSL#3 can be kept for up to two weeks at room temperature unrefrigerated, allowing for easy use when traveling.

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Physicians and pharmacists interested in additional information about the product can call 1-866-634-2765, and consumers may call 1-866-GET-VSL3 or visit http://www.vsl3.com for more information. To learn more about probiotics and IBS, visit http://www.youtube.com/vsl3probiotic. For more information on Consumerlab testing, visit http://www.consumerlab.com.


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