Morinaga Milk Industry Co., Ltd., (TOKYO:2264) today announced it has attained self-affirmed GRAS (generally recognized as safe) status in the United States for LAC-Shield, a unique immunogenic ingredient. This development opens the door for manufacturers of dietary supplements, functional foods and beverages in the U.S. to include LAC-ShieldTM in products designed to enhance immune function.
Thanks to mounting research demonstrating the positive health benefits of probiotics, the probiotics market has experienced explosive growth over the past decade. In fact, according to Nutrition Business Journal, probiotics posted 17 percent year-over-year growth from 2015 to 2016 in the United States — the highest of any supplement category. BCC Research predicts the global market will grow to USD $50 billion in 2020, as people’s awareness of and interest in healthful products continues to increase. However, the market is evolving beyond conventional probiotics to include metabolites of probiotics and non-viable microbes — called “immunogenics” or “immunobiotics.”
LAC-Shield (Lactobacillus paracasei MCC1849), widely recognized in Japan for its ability to enhance immunity, is one such ingredient. Unlike live cultures, LAC-Shield is rendered non-viable by heat treatment. Yet LAC-Shield still induces the production of a cytokine which activates and stimulates immune function.
LAC-Shield’s immune-boosting power was recently demonstrated in a human clinical study Morinaga Milk conducted with Kyushu Women’s University, which found it can lower the risk of contracting the common cold in susceptible subjects (Murata et al., Benef Microbes. 2018, in press). Another human clinical study, reported by Maruyama et al. (Int J Food Sci Nutr. 2016), found LAC-Shield may enhance the immune responses of the flu vaccine in the elderly with immunosenescence.
One of the most noteworthy aspects of LAC-Shield is the diversity of its potential applications. Usually, probiotics are difficult to incorporate into functional foods and beverages because of their intolerance of high temperatures and moisture. However, since LAC-Shield is pasteurized, it is highly tolerant of high heat and humidity, making it easy for manufacturers to incorporate it into a wide variety of products.
“In recent years, people have been demanding additional value and health benefits from the foods they consume. LAC-Shield has excellent potential to respond to those needs in the global market,” said Ko Shiino, General Manager of the International Division at Morinaga Milk. “Achieving GRAS status enables LAC-Shield to be included in a wide variety of functional foods and beverages. We will continue our efforts to gain GRAS status for other probiotics in our portfolio so that we can contribute to healthier and brighter futures of people throughout the world.”
Morinaga Milk has a solid track record with GRAS ingredients. It attained GRAS status for its flagship probiotic Bifidobacterium longum BB536 (GRAS Notice No. GRN 000268) in 2007 and for Bifidobacterium breve M-16V (GRAS Notice No. GRN 000453 and GRN 000454) in 2013. BB536 is well-known for its stability, quality and wide-ranging functional effects, as shown by 160 scientific reports, including numerous clinical studies. M-16V is well-known for its strong safety profile and its efficacy in infants, having been used in more than 120 Neonatal Intensive Care Unit (NICU) hospitals in Japan for low-birth-weight infants to support healthy growth. As a result, Morinaga Milk attained not only FDA-notified GRAS status for M-16V, but also GRAS status for infants.