The nutritional marketplace, currently estimated at about 190 billion USD for global dietary supplements, is influenced by consumer pull and by business operator push like any other marketplace. Consumer pull is usually reflected in the whatever major health concerns are currently among the top five. Wise market observers will try to predict the movements in the marketplace by trying to predict which health concerns will dominate in the near future.
With the global obesity epidemic going strong and increasing, it is currently not hard to predict that morbidities associated with too much weight and abdominal fat will also increase, and that consumers, at least those aware of the problem, will try to adjust their diets to compensate. One of the most severe conditions resulting from obesity is diabetes, the incidence of which is currently rising alarmingly in Asian countries, and also in the Western industrialized nations, albeit at a more moderate pace.
Accordingly, foods with a low glycemic index are expected to become attractive in these markets – which is practically the global marketplace. This will increase market chances for sugar alternatives such as Stevia and will also encourage innovation with less known botanicals.
However, these new ingredients will first have to take the hurdle of safety evaluations in markets such as the EU, where a Novel Food authorization is required for all substances that do not have a history of safe food use in the EU before 15 May 1997.
And speaking of regulatory hurdles – Europe really is a special case within the global marketplace.
During the past few years, our understanding about the importance of the food we eat for our health has received new input. As scientists investigate the many functions of the gut microbiome (and of other, related microbiomes like the oral mucosal one), it becomes more and more obvious that many non-communicable diseases may indeed be rooted in our diet.
The gut microbiome and its connection to the human central nervous system – the so-called gut-brain axis – is currently a hot topic for scientific investigation. Where before, the best known function of the gut microbiota was immune modulation (which in itself is a very important function), we can now make links to IBS, mood (including stress, anxiety, and depression), obesity, cognition, sleep, and even neuropsychological disorders like ADHD and autism, and neurodegenerative diseases such as Parkinson’s and Alzheimer’s.
It is not surprising, therefore, that probiotics and prebiotics are soaring globally. As more gut microbiome functions and more probiotic and prebiotic foods that can help support these functions are discovered, the upwards trend of products is expected to continue.
What’s baffling is the fact that Europe, where yoghurts and the knowledge of how good they are for you are part of traditional diets, is currently being left behind market-wise, due to the restrictive regulatory environment.
Botanicals, in the same kind of bind in that they are prohibited from making health claims (excepting the so-called pending claims), can at least be the subject of “contains” claims and may be mentioned on product labels. Probiotics and prebiotics cannot even do that. The European Food Safety Authority (EFSA) considers the words “probiotic” and “prebiotic” to be health claims, and no health claims have been authorized for these ingredients. Therefore, mentioning these words is currently prohibited.
This de-facto censoring results in keeping valuable knowledge about their daily diet from consumers, and it is also affecting innovation and market growth in an important sector that is soaring everywhere else in the world. The benefits of probiotics are currently fueling the new category of personalized nutrition and are a crucial part of infant nutrition as well.
Meanwhile in the EU, regulatory constraints are forcing food business operators to seek out regulatory loopholes which will in all likelihood disappear soon, as is currently the case with the Medical Device loophole in the EU for substance-based products, which has become inaccessible for probiotics following a revision of the Medical Devil Regulation, now (EU) 2017/745.
Same as with the botanical health claims, the problem with probiotic health claims lies in EFSA’s insistence on applying drug-like measuring sticks to food health effects. There is no “one substance – one effect” paradigm in biological matrices, let alone in living organisms like bacteria. Should EFSA solve this basic problem and actually start allowing botanical and probiotic health claims to go through, this would certainly change the landscape of the European nutritional market substantially and quickly.
This demonstrates the difficulties inherent in predicting market developments. Changing regulatory environments, more than consumer pull, will have a drastic impact on innovation and market growth. The future (and EFSA’s future approach to evaluating health claims) will tell whether the EU will catch up with the global nutritional marketplaces.
by Joerg Gruenwald
Joerg Gruenwald, PhD, is Founder and Chief Scientific Advisor of Analyze & Realize GmbH in Berlin, Germany, a specialized research and consulting company for natural health products, phytomedicines, functional foods, dietary supplements etc. He has authored and edited 13 books, including Physician’s Desk Reference (PDR) for Herbal Medicines, Plant-Based Ingredients for Functional Foods, Grüne Apotheke and acted as a co-editor of the American Botanical Council’s The Complete German Commission E Monographs, as well as over 300 scientific articles. He serves as Expert Committee Member of the United States Pharmacopoeia (USP) Committee on Botanical Dietary Supplements and Herbal Medicines from 2015-2020 and as Vice Chair of their Admission Evaluation Joint Subcommittee. He is Board Member of the American Botanical Council (ABC) and editor and editorial board member of 7 scientific journals, e.g. „Phytomedicine“. He has worked as advisor to the Office of Dietary Supplements at the U.S. National Institutes of Health, was chairman of the American Herbal Products Association’s International Committee and member of the Council
for Responsible Nutrition’s Botanical/Quality Standards Committee. He regularly serves as Chairman and speaker at international conferences like Vitafoods, Health Ingredients, Food Ingredients etc.