The approval is the first for DuPont in Brazil, and allows brands in Brazil to bring new probiotic foods and dietary supplements faster to market using the health claim.
“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,” said 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.”
On-pack claim
The approval allows foods and supplements containing the strain to claim ‘Bifidobacterium lactis HN019 may contribute to gastrointestinal health’ on product 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,” said Carolina Zago, Regulatory Affairs South America, DuPont Nutrition & Health.
Supported by science
DuPont has hailed the approval as a triumph. ANVISA elevated its requirements for approving probiotic-enriched products in 2015, leading to multiple rejected applications because of insufficient documentation of safety or efficacy.
The benefits of HN019 on gastrointestinal health and immune function are supported by numerous in vitro and clinical studies, said the company. The strain’s ability to favorably modulates the composition of gut microbiota, even at a low dose, is supported by two dietary intervention studies, added the company.
In addition, a meta-analysis of four clinical trials concluded that daily consumption of HN019 enhances cellular immune activity in healthy elderly adults.
“We are continuing our work to get new probiotic strains included on the positive list in Brazil. This hard works follows success in Switzerland where DuPont Danisco Bifidobacterium lactis HN019 probiotic also was recognized as supporting digestion by reducing transit time as well as in Japan where HN019 was recorded to improve defecation for those suffering from constipation allowing food manufacturers to state a health claim on the product,” said Megan DeStefano, global marketing manager, Probiotics, DuPont Nutrition & Health.
“These positive outcomes further validate the strong scientific evidence DuPont has on the link between digestive health and probiotics, and we look to build on these approvals in the future.”