DuPont’s customers in Brazil can now use the claim “Bifidobacterium lactis HN019 may contribute to gastrointestinal health.”
DuPont Nutrition & Health (Geneva) can now use a digestive health claim in Brazil for its Bifidobacterium lactis HN019 probiotic strain. The company announced it received health claim approval from the Brazilian Health Regulatory Agency (ANVISA). According to the company, its customers in Brazil can now include the claim “Bifidobacterium lactis HN019 may contribute to gastrointestinal health” on food and dietary supplement product packaging.
DuPont says that Bifidobacterium lactis HN019 is the first of its probiotic ingredients to qualify for an approved health claim in the Brazilian market. DuPont calls the approval of this health claim “a particular triumph” given that, in 2015, ANVISA ramped up its requirements for approving probiotic-enriched products, including requiring additional safety and efficacy documentation. DuPont points out that many applications for other companies’ probiotic products have failed due to insufficient documentation of safety or efficacy under these heightened ANVISA requirements.
“During its careful evaluation process, the health authority has recognized the potential health effect of HN019 and our expertise as a reliable probiotic supplier,” said Carolina Zago, regulatory affairs South America, DuPont Nutrition & Health, in a press statement. “For our customers, it means the approval process for their products is more likely to be swift and successful.”
DuPont says that its extensive body of research on HN019 supports the new health claim. For example, DuPont points to in vitro study data which showed HN019’s beneficial effects on gut health and immune function. In two other dietary intervention studies, HN019 helped favorably modulate the composition of microbiota in the gut, even at a low dosage. Finally, a meta-analysis of four existing clinical trials demonstrated that daily consumption of HN019 enhanced cellular immune activity in an elderly population.
“Our gastrointestinal system is an extremely complex ecosystem-and represents our greatest area of contact with the environment,” said Daniel Borges, dietary supplements sales manager, DuPont Nutrition & Health, in the press release. “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. By approving this health claim, ANVISA has recognized the ability of HN019 to help keep that ecosystem in balance.”
The new Brazilian health claim follows the success DuPont saw when the company gained an approved digestive health claim for HN019 in Switzerland back in 2014, which was the first approved health claim in Europe for a probiotic. HN019 also earned a health claim in Japan recognizing its ability to improve constipation symptoms. “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,” said Megan DeStefano, global marketing manager, Probiotics, DuPont Nutrition & Health.
In addition to Bifidobacterium lactis HN019, DuPont also offers a portfolio of other probiotic cultures for foods and dietary supplements. DeStefano said that the company is working to get new DuPont probiotic strains on the “positive list” in Brazil.