Biothera: ‘Using vitamins and minerals alone to support immune claims is not enough’
However, they have learned some lessons from recent litigation in this area, said Richard Mueller, president of Biothera's healthcare group.
Mueller was speaking to NutraIngredients-USA after cookies featuring its Wellmune WGP immune health ingredient were rolled out to 500 Walmart stores.
He said: "Because of the consumer opportunities in the immune category, the majority of manufacturers are not afraid to go after this market as long as they are using ingredients supported by strong science.
“[But] these manufacturers recognize now because of litigation that using vitamins and minerals alone to support an immune claim is not enough."
He added: "They need to be using ingredients based on numerous clinical studies demonstrating the direct correlation between the ingredient and the immune health benefit."
Human clinical studies
Several big food and supplement brands have got into trouble over immunity claims in recent years, the latest being Amway, which has been threatened with legal action if it does not amend claims that its Nutrilite Immunity twist tubes - which contain vitamin C and B vitamins - are an immune system booster. Click here for more details.
Kellogg has also invoked the wrath of the FTC for claiming that Rice Krispies ‘help support your child’s immunity’, while probiotic players including Dannon, Nestlé and Bayer have all faced legal challenges over immunity claims.
However, firms should not encounter legal problems provided they use ingredients that are supported by strong clinical evidence, said Mueller.
“Wellmune WGP has nine clinical studies, six of which have been published or accepted for publication in major peer-reviewed journals. This research supports numerous immune and wellness claims, ranging from 'enhances the immune system' to 'reduces the harmful effects of stress'."
Borrowed science is not acceptable
He added: “Regulatory authorities worldwide are demanding that ingredients base claims on research with their own specific ingredient strain and not rely on 'borrowed' research that was conducted with another product or ingredient in the same category.”
And this applied to yeast beta glucans as well as probiotics, he said:
“Our research has demonstrated that even slight molecular differences among yeast beta glucans can affect biological activity. So it is important to note that not even all yeast beta glucans are alike. Each yeast strain has different molecular structures with different health benefits.
“Each product should be supported by research conducted with that specific kind of beta glucan and the strain of yeast it is derived from. As regulators have noted with differing probiotic strains, borrowed science is not acceptable.”
What is Wellmune WGP?
Derived from the cell wall of a proprietary strain of baker’s yeast, Wellmune WGP beta glucan ‘primes’ the innate immune system - the body’s first line of defense against invasion by bacteria and viruses – and can withstand wide pH ranges, high temperatures and harsh processing conditions, claims Biothera.
To produce it, Biothera removes the mannans, proteins and lipids from a proprietary strain of yeast to produce a highly purified beta 1,3/1,6 glucan (which should be distinguished from cholesterol-busting oat beta glucan, which has a different molecular structure: 1,3/1,4).
Unlike many probiotics, which have typically been used in short shelf-life refrigerated products, Wellmune WGP has a five-year shelf life in powder form under ambient storage conditions and a mild taste.
Development projects in most food, beverage and supplement categories
Said Mueller: “There are product development projects with Wellmune WGP in most food, beverage and supplement categories in the US with major manufacturing companies. Some of these projects have timelines for introduction this year."
Praeventia cookies – made by Groupe Biscuits Leclerc - contain Wellmune WGP and make the claim ‘beta-glucan activates key immune cells’.
