Sabinsa self-affirms GRAS for probiotic ingredient

By staff reporter

- Last updated on GMT

Related tags Gras status Probiotic North america

Sabinsa has self-affirmed the GRAS status of its probiotic LactoSpore ingredient, giving an extra layer of assurance that it is safe for use in food and beverage products, as well as supplements.

According to the company, the ingredient is Bacillus coagulans​, formerly known as Lactobacillus sporogenes​, and it is a shelf stable (at room temperature) probiotic.

The strain was first introduced about a decade ago. Lakshmi Prakash, PhD, VP of innovation and business development for Sabinsa said that customers valued the ingredient because of its convenient storage and handling attributes. The strain does not require refrigeration to maintain its reported health benefits, she said.

The strain is in the sporulated form, said the company, and this enhances survival and proliferation in the gastrointestinal environment unlike vegetative cells that may be destroyed under these conditions. The culture produces only the beneficial L-(+) form of lactic acid in the gastrointestinal tract.

GRAS status is the standard set by the US Food and Drug Administration (FDA) for ingredients to be approved for use in foods and beverages. Companies can either apply to FDA for GRAS affirmation, or they can self-affirm their products as GRAS by conducting all relevant safety and quality evaluations.

LactoSpore’s GRAS status was determined by an independent panel of scientists, assembled by Soni & Associates, who reviewed safety and toxicology data.

“Achieving GRAS status highlights our ongoing commitment to ensuring regulatory compliance for our customers, as well as our dedication to developing highly functional and safe ingredients that become cornerstones of our customer’s products,”​ said Shaheen Majeed, the company’s marketing director.


GRAS approval will now allow food manufacturers to add LactoSpore to a variety of foods and beverages ranging from baked goods to milk products, soups, snacks, candy, non-alcoholic beverages and even instant tea and coffee.

Majeed told that the ingredient is primarily used in dietary supplements, but the company does have several prospects in the food area.

Booming marketplace

The US market for probiotic products still significantly lags behind the European market, which has traditionally led the food and beverage market for digestive health.

According to data provided by Mintel, there were 699 new food and beverage products targeting digestive health launched in Europe in 2007, some 52 percent higher than the year earlier.

In North America, the market researcher's Global New Products Database (GNPD) recorded 136 new products launched last year. However, the North American region recorded the highest growth rate of 131 percent between 2006 and 2007.

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