Royal DSM’s gut health portfolio has surpassed a big regulatory hurdle in the U.S. with New Dietary Ingredient (NDI) status of its Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri 12246-CU probiotic strains following the FDA’s review with no objection.

The strains—Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri 12246-CU—demonstrate multiple clinically-proven gut-related benefits when combined, including improved digestive comfort and reduced diarrhea, according to the company. The strains are already commercially available in Europe, Asia, and the Middle East.

DSM said the regulatory status will enable dietary supplement brands to expand their portfolios to cater to the booming gut health trend. As microbiome science continues to evolve, the world’s understanding of the link between good gut health and overall wellbeing is taking shape. The DSM Consumer Health Concerns Study 2021—which surveyed almost 19,000 consumers across 24 countries—revealed that 61% of consumers worldwide are now concerned about their gut health and 67% of those take action to support it.

“Our growing global presence in the gut health market signifies our continued investment in this trending category, where growth is driven by changing consumer mindsets,” said Jill Porter, global director gut health, dietary supplements, DSM. “Customers can trust that DSM will help them navigate the developing science and awareness around holistic gut health—enabling them to bring targeted health solutions to market faster.”

“The NDI status of our two flagship strains strengthens confidence in our science-based ingredients and creates a multitude of opportunities for our U.S.-based customers to remain at the forefront of the market,” said Penny Antonopoulos, director dietary supplements, human nutrition & care, North America, DSM.

Both strains were identified through a screening program to be among the best performing probiotic varieties out of a total of 47, Antonopoulos noted. “Both strains, for example, demonstrated excellent pH tolerance and adhesion properties to enable passage through the gastrointestinal tract and strong antimicrobial activity against pathogenic bacteria.^1,2 Because of this, the strains were specifically chosen to support customers looking to innovate in the gut health space across a number of applications.”

1. Rosenfeldt et al. Faecal recovery, mucosal adhesion, gastrointestinal effects and tolerance of mixed cultures of potential probiotic Lactobacilli. Microbial Ecology in Health and Disease, 2003.
2. Jacobsen et al. Screening of probiotic activities of forty-seven strains of Lactobacillus spp. by in vitro techniques and evaluation of the colonization ability of five selected strains in humans. Applied and Environmental Microbiology. 1999.