DuPont Nutrition & Health Science has earned approval from the Brazilian Health Regulatory Agency (ANVISA) for its Bifidobacterium lactis HN019 probiotic strain. The regulatory green light marks the recognition of the science behind the strain and allows an on-pack health claim. Customers in Brazil can now bring new probiotic products and dietary supplements faster to market using the first DuPont probiotic to qualify for an approved health claim on the local market.

The approval means eligibility for the claim, “Bifidobacterium lactisHN019 may contribute to gastrointestinal health” to appear on dietary supplements and probiotic products packaging.

“During its careful evaluation process, the health authority has recognized the potential health effect of HN019 and our expertise as a reliable probiotic supplier. For our customers, it means the approval process for their products is more likely to be swift and successful,” says Carolina Zago, Regulatory Affairs South America, DuPont Nutrition & Health.

Since 2015, when ANVISA stepped up its requirements for approving probiotic-enriched products, many applications have failed due to insufficient documentation of safety or efficacy, DuPont explain. This makes the approval of HN019 a particular “triumph.”

DuPont can cite numerous in vitro and clinical studies that have documented the positive effect of HN019 on gastrointestinal health and immune function. In two dietary intervention studies, consumption of HN019 was seen to modulate the composition of gut microbiota favorably.

Furthermore, a meta-analysis of four clinical trials also has shown that daily consumption of HN019 enhances cellular immune activity in healthy, elderly adults.

“Our gastrointestinal system is an extremely complex ecosystem – and represents our greatest area of contact with the environment. We rely on our gut microbiota to digest and absorb nutrients, excrete waste products and stimulate the body’s immune response, so we are better protected from potential pathogens,” says Daniel Borges, Dietary Supplements Sales Manager, DuPont Nutrition & Health.

“By approving this health claim, ANVISA has recognized the ability of HN019 to help keep that ecosystem in balance.”

DuPont probiotics on the European market
The company has an existing portfolio of scientifically proven DuPont Danisco probiotic cultures for foods and dietary supplements, which are ready for sale in a range of formats.

At Vitafoods Europe 2018, Liisa Lehtoranta, Research Manager at DuPont Nutrition & Health, talked about the use of HN019 for the elderly.

“At DuPont we have a probiotic product called Howaru Protect Senior. We recently published a meta-analysis where we researched how this strain affects the cellular immune health of healthy seniors. In this meta-analysis, we pooled data from four clinical trials. The results were that it was highly efficacious in enhancing the key immune cells fighting against bacterial and viral infections,” says Lehtoranta.

Regarding applications, the Howaru Protect Senior probiotic product will take form in delivery formats most suitable for aged populations: “powder formats are a good way to administer probiotics for seniors as they can be added easily to yogurt, drinks or juice,” adds Lehtoranta.

For DuPont, probiotics bring “unlimited possibilities,” and the expanding market is not expected to slow down, Lehtoranta explains.

Probiotic's growth
Innova Market Insights data reflects the growth of a market that does not show signs of stagnating. The data notes that nearly 96 percent of global launches in the 12 months to the end of June 2017 were positioned on a health platform of some kind. Of this, almost 56 percent of introductions featured a digestive health and/or probiotic claim.

As companies innovate with probiotics, gut health claims are also moving away from just the dairy aisles. For example, DuPont's Howaru Protect Senior powdered probiotic will be suitable for beverage applications including juices.

Official authorization for on-pack health claims can carry heavy weight in the market, as attaining such certifications can be difficult. However, there is a huge amount of scientific research going in this arena that may further enhance probiotic's future scientific backing:

“Scientific tools have come a long way since the invention of the microscope. The development of ‘omics’ methodologies means that now on top of identifying bacterial strains, genes and functional pathways can also be characterized and this data can be used to try to untangle the complex interactions between gut microbiota and health,” Dr. Stacey Lockyer Ph.d, Nutrition Scientist at the British Nutrition Foundation, tells.

“So, there is much more to be discovered in the probiotic research arena,” she adds.

Indeed, DuPont state that they are continuing in their attempts to get further strains recognized in Brazil, following the success of the Bifidobacterium lactis HN019 strain being recognized in Switzerland and Japan under similar health claims