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“Ingredient safety is paramount to all of our products from microbial strains to digestive enzymes.”
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“We have been selling this safe and remarkably stable ingredient in the dietary supplement and food market for a number of years. This unopposed letter opens the door to more formulation options, including functional foods and beverages,” said BIO-CAT CEO and Co-Founder Chris Schuler said in a company publication.
In fact, microbial ingredients can be found in a variety of formats, including cereals, pasta, baked goods, seltzer, and juices. BIO-CAT Microbials OPTI-BIOME® MB40 is particularly well suited for food and beverage formulation as this ingredient naturally contains a thick layer of protein that withstands the harmful effects of high heat, low pH and days in retail.
The positive reaction of the FDA follows the publication of the safety assessment OPTI-BIOME® MB40 in February in the journal Nutrients2. In addition to bioinformatic and in-vitro studies, the safety assessment included strict tests of the safety and tolerability of OPTI-BIOME® MB40 in animals and humans. Overall, the studies support the safe use of OPTI-BIOME® MB40 in food supplements with up to 10 billion CFU per day and in foods with up to 2 billion CFU per serving.
“For human nutrition, ingredient safety is of paramount importance to all of our products from microbial strains to digestive enzymes. We are committed to safety tests that exceed minimum expectations, especially for probiotic strains of species that are relatively new to the market “confirms Schuler.
The announcement by BIO-CAT Microbials, LLC is in line with an increased industry focus on probiotic studies. PubMed states that published probiotic research has doubled from 2,234 peer-reviewed publications in 2015 to 4,442 publications in 2020.3 The industry is researching not only the benefits of probiotics, but the NIH budget as well $ 812 million also for probiotic research in 20204.
Please direct all inquiries to BIO-CAT Microbials at (877) 912-4622 or to [email protected]
1. Recently published GRAS notices and FDA letters | FDA
2. Spears JL et al. Safety assessment of Bacillus subtilis OPTI-BIOME® MB40 for use in food and dietary supplements. Nutrient. 2021.
3. https://pubmed.ncbi.nlm.nih.gov/?term=probiotics&filter=years.2000-2021
4. https://report.nih.gov/funding/categorical-spending#/
About BIO-CAT Microbials LLC: BIO-CAT Microbials LLC, based in Shakopee, Minnesotawas founded in 2004 by BIO-CAT Inc., a leading company in the enzyme industry in Troy. Virginia. BIO-CAT Microbials LLC has focused on three core areas of life sciences for 17 years: human nutrition, animal nutrition and plant nutrition. BIO-CAT Microbials LLC continues to be an innovative global biotech leader supporting customers with advanced microbial solutions. As industry experts, her scientifically led team specializes in strain development, fermentation and product development. More information is available at www.bcmicrobials.com.
SOURCE BIO-CAT Microbials LLC
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