Health Canada outlines plan to incorporate Lactobacillus changes while FDA waits

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / ayo888
© Getty Images / ayo888

Related tags: Probiotics, Lactobacillus, taxonomy

Health Canada has reiterated its stance that changes to product labels due to reclassification of species within the old Lactobacillus genus should occur within three years of changes to its monograph.

Speaking at the International Probiotics Association’s DC Workshop late last year, Michael Steller, Unit Head, Health Products and Food Branch, Health Canada, said that the reclassification will require changes to be made to the NHPID (Natural Health Product Ingredient Database) and Health Canada’s probiotic monograph.

Health Canada would then expect changes to labels to occur within three years of the monograph change, he said.

Steller confirmed to NutraIngredients-USA this week that this is still the plan but noted that the process may be delayed due to ongoing disruption caused by the novel coronavirus.

“Workload is extremely high at NNHPD within Health Canada at the moment (specifically impacted by urgent hand sanitizer/disinfectant needs and policies), so the point at which we’ll actually get to the NHPID and monograph adjustments for probiotics will likely be delayed,” ​Steller told us.

“Also, for proactive companies/labelers, as long as they have an NPN that is valid, updated nomenclature on the label should not pose an impediment at the border (a reminder that the full Latin binomial is required for Canadian labelling).  Beforehand, an amendment to the license and a request for the naming adjustment in NHPID should ideally be made​.

“Currently, there is no other plan for NNHPD to release any other policy updates related to probiotic nomenclature,” ​ added Steller.

US FDA: We’ll wait and see

On the other hand, the US FDA has not committed to a timetable, with Marianna Naum, PhD, Team Lead, Strategic Communications at the US Food and Drug Administration, telling NutraIngredients-USA: “If the proposed taxonomic changes are accepted by the scientific community and start to be widely used in the literature, FDA will consider how best to transition to the new terms across the wide range of food products and ingredients that it regulates, including dietary supplements and standardized or non-standardized conventional foods.”

Taxonomic changes to Lactobacillus

As reported by NutraIngredients-USA last week​, the taxonomic changes to the genus Lactobacillus were finally published in the International Journal of Systematic and Evolutionary Microbiology​ (IJSEM).

The genus Lactobacillus​ was had grown over the years to include over 250 species. According to the new reclassification, Lactobacillus​ is again limited to only 35 species. The other species have now been formally put into 23 new genera and Paralactobacillus.

For example, L. reuteri​ is now Limosilactobacillus reuteri​ (so still L. reuteri​), L. rhamnosus​ is now Lacticaseibacillus rhamnosus, L. salivarius​ is now Ligilactobacillus salivarius, L. casei​ is now Lacticaseibacillus casei, L. paracasei​ subsp. paracasei​ is now Lacticaseibacillus paracasei​ subsp. paracasei​, and L. plantarum​ subsp. plantarum​ is now Lactiplantibacillus plantarum​ subsp. plantarum​.

The University of Alberta has released a tool, which is available HERE​, to allow stakeholders to quickly search the old names to discover the new names.

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