Specialty Enzymes & Probiotics’ SEBclausii probiotic gets GRAS pass from FDA
14 Mar 2022 --- SEBclausii, a brand of Bacillus clausii made by Specialty Enzymes & Probiotics, has obtained “Generally Recognized as Safe” (GRAS) status by the US Food and Drugs Administration (FDA) following a review. Specialty Enzymes & Probiotics says the strain is suitable for nutraceutical, food and beverage applications, and more.
SEBclausii’s GRAS designation comes along with a No Further Questions letter by the FDA. This means the FDA evaluated information supplied by Specialty Enzymes & Probiotics and found nothing that conflicted with the FDA’s general safety guidelines. This allows Specialty Enzymes & Probiotics to legally sell the ingredient in the US.
The GRAS label is not the same as full approval by the FDA; the FDA has only stated the product does not contain anything known to be hazardous based on the company’s own reporting. However, the GRAS label may indicate a future path to full approval by the FDA, pending clinical trials of the branded ingredient.
Resourceful ingredient
The ingredient is vegan, kosher and halal-friendly and has been certified by the Non-GMO Project. The company assures the probiotic can be used with antibiotics without impacting efficacy. Bacillus clausii is one of the company’s more than 25 probiotic strains, including Lactobacillus, Saccharomyces, Bacillus and Bifidobacterium, all GRAS.
The brand of Bacillus clausii is shelf-stable and spore-forming. According to Specialty Enzymes & Probiotics, the ingredient creates a “protective endospore” around itself. This allows the ingredient to survive the journey to the gut without denaturing.
Innova Market Insights notes probiotics are a fluctuating category depending on application.The company says the probiotic can handle manufacturing and distribution processes without needing refrigeration. This means using the ingredient over non-shelf-stable alternatives can help save manufacturers money on resources, the company notes.
Experts have flagged functional F&B as largely unexploited territory with ample potential for probiotics.
Probiotic demands spurring innovation
In 2020, Innova Market Insights highlighted that consumers were increasingly looking to probiotics as a part of rising concerns for immunity amid the COVID-19 global pandemic. Gut health has been a rising category since before COVID-19. Innova Market Insights also reports that F&B launches making digestive/gut health claims rose 21% in 2018.
An industry roundtable in 2021 found the push for gut health support was largely fueled by rising consumer awareness of the role of the gut beyond digestive health. As a part of immunity concerns fueled by the COVID-19 pandemic, consumers are looking toward gut health support as a holistic health solution.
Interestingly, however, Innova Market Insights noted last year that sports nutrition launches making probiotic claims had started to trend downward between 2019-2020 by as much as 18%.
What does the science really say?
This being said, studies on unbranded forms of Bacillus clausii have flagged its beneficial effects on immunity and liver function, signaling a multitude of applications for the ingredient.
In 2007, Bacillus clausii was highlighted by Italy-based researchers, who found preliminary evidence the ingredient could help shorten the duration of respiratory infections in children. The study, published in Therapeutics and Clinical Risk Management, found the ingredient was safe and well-tolerated by children in the study.
Ukraine-based researchers also found a probiotic drug containing Bacillus clausii had a positive effect on the humoral immune system of children battling rotavirus in a 2019 study released by Aluna Publishing.
Similar effects were recorded in a 2021 study conducted on broiler chicks by Pakistan-based researchers, who found the probiotic significantly improved chicks’ humoral immunity and liver function. The study, released by Journal of the Saudi Society of Agricultural Sciences, indicates the probiotic may even have applications for livestock and pet health.
Edited by Olivia Nelson
