The announcement comes just a few months after LactoSpore received a “no questions” letter from FDA regarding its Generally Recognized as Safe (GRAS) submission.
Canadian products containing Sabinsa Corp.’s (East Windsor, NJ) LactoSpore probiotic ingredient (Bacillus coagulans MTCC 5856) are now licensed to carry a health claim that speaks to its benefits for symptoms of irritable bowel syndrome (IBS). Sabinsa announced last week that Health Canada has approved the following claim for LactoSpore Balance: “Helps relieve abdominal pain associated with IBS.”
“This health claim was based on the IBS clinical study we did for LactoSpore,” says Shaheen Majeed, Sabinsa’s marketing director. “It gives us great validation for the clinical work we’re doing globally.” Details of recent research on LactoSpore and IBS symptoms can be found here.
The Canadian health claim announcement comes just a few months after LactoSpore received a “no questions” letter from FDA regarding its Generally Recognized as Safe (GRAS) submission for use in a variety of foods and beverages.
Sabinsa notes that LactoSpore has been on the market for more than 20 years, although emerging research has moved the ingredient’s focus “beyond maintaining gut health” and into other health areas, including cognitive health, sports nutrition, and IBS.
Nutritional Outlook Magazine