Cargill receives GRAS no objections letter from FDA for EpiCor yeast fermentate as ISAPP defines ‘postbiotics’

Cargill-receives-GRAS-no-objections-letter-from-FDA-for-EpiCor-yeast-fermentate-as-ISAPP-defines-postbiotics.jpg
Unlike probiotics, which are ‘live’ microbes, postbiotics are not ‘live’ and can be used in a wider variety of food & beverage applications. Picture credit: Cargill

The FDA has responded with a letter of no objection to Cargill’s GRAS (Generally Recognized As Safe) notification for EpiCor – a ‘postbiotic’ ingredient claimed to have immune, digestive, and respiratory health benefits.

Unlike probiotics, which are ‘live’ microbes, postbiotics are not ‘live’ and therefore can be used in a wider variety of products that don’t need refrigeration or special processing conditions to maintain their viability, making them attractive to food and beverage formulators.

Acquired by Cargill as part of its 2017 acquisition of Diamond V Mills, EpiCor​​ is a heat- and pH-stable yeast fermentate made with a proprietary Non GMO strain of Saccharomyces cerevisiae​ (baker’s yeast).

An umami-tasting shelf-stable powder that can be described on US ingredients lists as ‘yeast fermentate,’ ‘dried yeast fermentate’ or ‘yeast fermentate made with Saccharomyces cerevisiae,’ EpiCor is highly soluble and dispersible in water (although not 100% soluble) and has a three-year shelf-life when stored as recommended in a dry environment in its original closed container.

According to Cargill's GRAS determination​​​, EpiCor can be used in a wide range of foods, including cookies, meal replacement and probiotic beverages, nutritional bars, soy milk, yogurt and yogurt beverages, soy protein bars, fruit beverages, chocolate confections, and soups.

‘Like a multivitamin for your immune system’​

The fact that EpiCor’s health benefits are backed by eight peer-reviewed human clinical studies - six of which are double-blinded, placebo-controlled ‘gold standard’ trials – gives it a significant advantage over many other functional ingredients trying to cross over from supplements into food & beverage, Cargill Health Technologies president Chuck Warta told FoodNavigator-USA in a recent interview.

This is especially true in the immune health space, which is being scrutinized by regulators as brands attempting to cash in on heightened consumer interest sometimes make claims that do not stand up to scrutiny, he argued.

“They really like the scientific rigor and background behind it. We like to say that EpiCor ‘acts like a multivitamin for your immune system,’ but it’s obviously up to the end product manufacturer what they put on the label … we’re seeing interest in things like ‘supports a healthy immune system’ or ‘supports digestive heath.’

How do you talk to consumers about postbiotics?​

A recent consensus statement from the International Scientific Association for Probiotics and Prebiotics (ISAPP) defines postbiotics as “a preparation of inanimate microorganisms and/or their components that confer health benefits on the host,” which “validates EpiCor as a postbiotic,” said Liz Spence, EpiCor general manager.  

According to Warta, Cargill is in advanced conversations with CPG brands about using EpiCor in a range of applications from yogurts to tea as it seeks to take it beyond dietary supplements into the mainstream food and beverage market.

When we acquired Diamond V, the EpiCor brand had a good reputation in the supplement space; it’s grown at a compound annual growth rate of 67% since we made the acquisition, and we’ve used that success and momentum to take this into functional foods and beverages.