The American Academy of Pediatrics (AAP) recently published a report where they examined the evidence for probiotics to prevent morbidity and mortality in preterm infants. They concluded that probiotics could not be recommended.
The report landed on the conclusion that “clinicians must be aware of the lack of regulatory standards for commercially available probiotic preparations manufactured as dietary supplements and the potential for contamination with pathogenic species.”
So are probiotics regulated? “Yep” Leyer said. “It’s all about the intended use and traditionally, probiotics have been sold predominantly in foods and as a dietary supplement. So more in the food space, whereby, it's very limited in terms of what we can say about probiotics in terms of health benefits. You can't treat, cure, mitigate diseases for example, on a product label, although they might be studied in those areas. So, the concept of probiotics, that they’re not being regulated is false, probiotics are regulated as a dietary supplement ingredient would be regulated. There is certain federal standards that we need to meet as a manufacturer. There's federal guidelines that are specific to dietary supplements in terms of how they are manufactured called good manufacturing practices (GMP), which are slightly different from food and slightly different from pharmaceuticals, but they certainly are regulated.”
When it comes to products aimed at infants and preterm infants, Leyer said Chr. Hansen’s approach is a very layered and rigorous process.
“We have our traditional dietary supplement category, which if you walk through any of our facilities, you would be extremely impressed with the cleanliness and the care that we take in it, but then we go a step further for infants,” said Leyer. “We make sure that there's no incompatibility with the ingredients, we make sure that the methods that we’re using for testing all along the value chain from raw ingredient in the fermenter to the probiotic itself, to everything it’s blended with and packaged into, that the method that we’re using have been validated to practically pharmaceutical standards.”
To hear more about why probiotics are more closely aligned with food rather than pharma, or how hospitals could go about implementing probiotics for vulnerable populations, listen to the NutraCast.
NutraCast is a podcast that focuses on insights from inside the nutrition industry. It is a production by NutraIngredients-USA. Music by Kevin Macleod.