Julie Ann Brickel, a research toxicologist for NSF, will give an overview of regulatory compliance trends in probiotics at the upcoming VitaFoods trade show in Geneva, Switzerland. Brickel told Nutraingredients-USA that the label certification scheme is growing along with the category.
“The number of probiotic products that we are seeing has been increasing in the past few years,” she said.
Inconsistency in labeling
With that growing sample size, Brickel said she had enough data to identify some trends in the labeling of these products. One trend is that some aspects of labels have been all over the map.
“We have seen some inconsistency in the labeling of the products,” she said. “To address that we put together an issue paper that we put out to our joint committee in 2016.”
Among the key issues within that paper was the question of how to call out the organisms contained in a product. Many advocates within the probiotics realm say that only by using a specific strain and labeling it as such can a high quality probiotic product be put together. The assertion is that the genetic variability of gut microbes means one strain of Lactobacillus acidopholus could vary from another as much as an elephant differs from a mouse. They are both have four legs, a head and a tail, but just listing them as ‘mammal’ is not specific enough.
Strain specificity is key
Brickel said to fully comply with the labeling requirement means the specific strain must be used with every probiotic organism listed. From the standpoint of her responsibilities this primarily related to properly fixing the identity of the ingredient and connecting that to the safety information on that ingredient. But of course it also connects to the efficacy data on that strain as well for claims substantiation purposes. This could be unwelcome news for those product developers trying to get by with generic ingredients.
“The genus, the species and the strain must be located on the label,”Brickel said. “The message relayed form the FDA is that each strain is considered an individual ingredient. In laymen’s terms, just listing the genus and species could mean too many things.”
CFU count considerations
NSF has also weighed in on the question of how the amount of these ingredients should be delineated. To fully comply with existing regulations, the ingredients should be delineated both in milligram amounts as well as in CFU counts. And the question of mixtures, which are becoming increasingly common in the industry, complicates the picture. In that case, NSF expects that a total CFU count for all constituents of the mixture ought to be provided. If a manufacturer wants to then go on to claim specific CFU counts for each component of the mixture, that’s up to them, but consumers should be able to easily see how big a dosage of bacteria they’re getting overall.
“A statement of CFUs is required. If you are just stating the milligrams of the material, you don’t really know how much of that material is alive,” Brickel said.
Brickel acknowledged that verifying the CFU claims is complicated by the mixture question. How a company verifies CFU counts and tests for the identity of all of the components of a blend is covered by NSF’s GMP certification activities. But she said it’s no secret that this is one of the problem children of the industry, and one that will need further attention from and cooperation by industry stakeholders and FDA.
“That is a challenging area for probiotics products,” she said.
For more on probiotics questions, look for coverage of NutraIngredients-USA’s upcoming Probiotia Americas face-to-face event scheduled for early June in San Francisco. For more information, click here.