Article #1 – In the next few weeks, RNI Consulting will discuss different topic around the Probiotic theme. With this series, you will learn about probiotics and the regulatory framework.
What’s in a name?
That which we call a rose by any other name would smell as sweet
-William Shakespeare, Romeo and Juliet
UPDATE FROM Dec. 20, 2019
Are we there yet?
While we don’t have an exact timeline for when the revisions will be completed, this also means that we are getting closer to a final publication and could see the taxonomy name changes within the next month or two. As the authors of the manuscript are busy addressing the reviewer’s comments, make sure you are ready to address the changes when they are published, and let RNI help with any taxonomy questions in the meantime.
This Shakespeare quote has been used numerous times in reference to the upcoming taxonomic name changes for the Lactobacillus genus that will impact probiotic dietary supplement and food products. While the name changes have important impacts for many aspects of probiotic products, including product labels, claim substantiation, patents, and trademarks, it is ultimately a change in name only, and it does not change any of the underlying and established characteristics of the organism. As this change approaches, it is important to prepare, and RNI is here to help you understand what this change means for your commercialized products and future product development.
What is taxonomy?
Taxonomy is the scientific method of classifying and naming organisms. Systematic naming is important to establish differences and similarities between groups, and for probiotics it is particularly important to consider the genus and species of an organism to help establish characteristics and safety.
Why is the taxonomy for the Lactobacillus genus changing?
The development of scientific understanding coupled with discovery of new organisms has led to an overwhelmingly large Lactobacillus genus. Since this group now includes 251 species, and considering there are significant differences between organisms within the Lactobacillus genus, this group is just too diverse to continue as one genus. Therefore, the scientific community has taken on the task of re-classifying the Lactobacillus organisms, which will allow for easier identification of new organisms and will make it easier to assess an organism for specific characteristics and safety based on the genus/species it belongs to.
Who is responsible for making the taxonomy changes
A group of fifteen scientific experts were assembled to address the need for taxonomy changes and in October 2019, they submitted a manuscript with their updated taxonomic proposal to the International Journal of Systematic and Evolutionary Microbiology (IJSEM), which will be accepted and published by the International Committee on Systematics of Prokaryotes.
Where will taxonomy changes be listed?
Official name changes will be established in the IJSEM publication. At the time of this writing, the manuscript is pending publication, but it is expected to be published by the end of 2019.
When will taxonomy changes go into effect?
The new names will be applicable as soon as the IJSEM manuscript is published. While the new names will need to be written into regulation to be enforceable, adoption of these names are expected throughout the global scientific community and will be used by EFSA, Health Canada, and FDA moving forward.
What are the changes?
We won’t know the exact final classifications and names till the IJSEM publication is final, but here is what we know:
- All species currently assigned to Lactobacillacea will be split into 26 genera, including 23 new genera
- One group will retain the “Lactobacillus” name designation
- New genera names for most commercially relevant strains will begin with “L” and will largely resemble the “Lactobacillus” term
- Species and strain names will remain the same
- New genus names will be longer for most (in order to keep similarities to the “Lactobacillus” name)
What are the potential impacts?
While the scientific community and industry may understand the changes, it is important to communicate these and document the changes effectively so that consumers as well as regulatory authorities understand the connection of the previous and new nomenclatures. For example, consumers may understand benefits of a Lactobacillus acidophilus strain, but may be unfamiliar with a new taxonomic name, leading to confusion.
What do probiotic manufacturers and suppliers need to do?
It is important to note that since the underlying characteristics of an organism are not changing, research, patents, trademarks, and safety data still apply – the challenge we face is effectively documenting the name changes, implementing changes throughout product documents, and clearly communicating the name changes to consumers.
For example, label regulations do not allow for non-mandatory information in the Nutrition or Supplement Facts panels, so communicating name changes on product labels in the U.S. presents unique challenges and having a compliant strategy is important. Additionally, since new names are likely to be longer, label space will have to be considered in order to meet required font sizes.
Companies should be proactive in developing updated information as education and communication are key. Here is where to start:
- Create a compliance strategy across your probiotic product lines
- Update all written information, including labels and packaging, advertising, technical data sheets, consumer communications, marketing documents, etc.
- Develop documentation clearly outlining the previous name and new name that can be easily referred to for regulatory authorities and consumers
- Use the new names for any new publications, scientific analyses, patents, and trademarks
Need help understanding how taxonomy changes will impact your documentation, product label, marketing copy and claim substantiation? RNI is here to help! We can help you develop effective communication and make sure your internal documents, labels and claims are compliant.