By Joerg Gruenwald, analyze & realize GmbH03.27.24
The discovery of the gut-brain axis may well have been the single greatest discovery to affect the consumer health industry in recent decades.
The concept of the gut microbiome, and the fact that we as humans coexist with roughly as many bacterial cells as the number of cells that make up our bodies, was known since the early-to-mid 20th century. And yet, the full impact that those bacteria have on our health was not recognized until recently, and is arguably still being discovered.
We did know that gut health is central to wellbeing—after all, lots of expressions in various languages are centered around the “gut feeling”—but we were not aware until recently that a healthy gut microbiome composition may affect our health well beyond indigestion and bloating.
The discovery of the gut microbiome has since been followed by the discovery of other microbiomes (e.g., in the armpits, on the face, in the ears, in the vagina, between the toes, etc.). But the gut microbiome seems to be central to our health in ways that those other microbiomes are not.
Impaired gut health is linked to a number of health conditions, from anxiety and depression to low energy levels, colorectal cancer, immune health, and obesity, to name a few.
Later confirmed by the EU Commission, EFSA decided that the term “probiotic” (as well as “prebiotic” and “symbiotic”) constitutes a health claim that needs to be authorized.
In spite of many applications having been submitted to EFSA, as of today, there is no authorized health claim for these ingredients, which means that these terms cannot be used on the product label. FBOs are limited to including the Latin names of the bacterial strains in the ingredient list and hoping that consumers will make the connection.
Some EU countries have since taken matters into their own hands. The EU’s biggest market, Italy, for instance, does not consider the term “probiotic” as a health claim. Instead, it is defined as a condition of use, removing it from the scope of the Nutrition and Health Claims Regulation (NHCR). This means that products manufactured and marketed in Italy can carry the word on their labels.
This, in turn, has led to a situation where probiotic products are imported from Italy to other EU countries via e-commerce, putting local manufacturers at a disadvantage.
EU member states have directed a number of questions at the EU Commission, asking when and how the EUC intends to address the matter. After all, the health benefits of probiotics are undeniable. The body of evidence grows daily. It does not make sense to keep this information away from the consumer. But as of today, there has been no response to any of the questions.
It remains to be seen whether the EU Commission will recognize all that and adjust its legislation accordingly. In the meantime, FBOs in the probiotic space will need to observe local requirements, ideally with the help of experienced consultancies such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com
The concept of the gut microbiome, and the fact that we as humans coexist with roughly as many bacterial cells as the number of cells that make up our bodies, was known since the early-to-mid 20th century. And yet, the full impact that those bacteria have on our health was not recognized until recently, and is arguably still being discovered.
We did know that gut health is central to wellbeing—after all, lots of expressions in various languages are centered around the “gut feeling”—but we were not aware until recently that a healthy gut microbiome composition may affect our health well beyond indigestion and bloating.
The discovery of the gut microbiome has since been followed by the discovery of other microbiomes (e.g., in the armpits, on the face, in the ears, in the vagina, between the toes, etc.). But the gut microbiome seems to be central to our health in ways that those other microbiomes are not.
Impaired gut health is linked to a number of health conditions, from anxiety and depression to low energy levels, colorectal cancer, immune health, and obesity, to name a few.
Regulatory Roadblock
Of course, food business operators (FBOs) ran with this, and a plethora of products containing probiotic, prebiotic, and symbiotic/synbiotic ingredients flooded the market—until in 2011 when the European Food Safety Authority (EFSA) practically put a stop to what was a thriving industry in Europe.Later confirmed by the EU Commission, EFSA decided that the term “probiotic” (as well as “prebiotic” and “symbiotic”) constitutes a health claim that needs to be authorized.
In spite of many applications having been submitted to EFSA, as of today, there is no authorized health claim for these ingredients, which means that these terms cannot be used on the product label. FBOs are limited to including the Latin names of the bacterial strains in the ingredient list and hoping that consumers will make the connection.
“Gut health as a trend is booming among consumers. A number of products ... are being touted on the social media platforms Instagram and TikTok as being particularly healthy. They have the views to prove that the gut health trend is here to stay, and that consumer interest and demand is as high as ever.”
Market Consequences
The impact of this decision has been measurable. Data published by Euromonitor revealed that as of 2010, the rise of consumer awareness in the probiotics and microbiome sector led to a surge in sales, with retail value growing by 350% globally between 2010 and 2022. Meanwhile, growth in Europe was only 180%, half of the average global growth.Some EU countries have since taken matters into their own hands. The EU’s biggest market, Italy, for instance, does not consider the term “probiotic” as a health claim. Instead, it is defined as a condition of use, removing it from the scope of the Nutrition and Health Claims Regulation (NHCR). This means that products manufactured and marketed in Italy can carry the word on their labels.
This, in turn, has led to a situation where probiotic products are imported from Italy to other EU countries via e-commerce, putting local manufacturers at a disadvantage.
EU member states have directed a number of questions at the EU Commission, asking when and how the EUC intends to address the matter. After all, the health benefits of probiotics are undeniable. The body of evidence grows daily. It does not make sense to keep this information away from the consumer. But as of today, there has been no response to any of the questions.
Consumer Demand Higher Than Ever
Meanwhile, gut health as a trend is booming among consumers. A number of products—including fermented drinks like kombucha, fermented foods like sauerkraut, and other products such as sourdough bread and foods naturally rich in prebiotics (e.g., beans, broccoli, and artichokes)—are being touted on the social media platforms Instagram and TikTok as being particularly healthy. They have the views to prove that the gut health trend is here to stay, and that consumer interest and demand is as high as ever.It remains to be seen whether the EU Commission will recognize all that and adjust its legislation accordingly. In the meantime, FBOs in the probiotic space will need to observe local requirements, ideally with the help of experienced consultancies such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com
