Panel discussion on...
Botanicals health claims:
current and future perspectives
Botanicals are defined by the European Food Safety Authority (EFSA) as “material, preparations or substances obtained from plants or other vegetative organisms, such as algae, fungi or lichen”; they are complex matrices of substances bonded together at a molecular level with multi-faceted applications (1).
Plant extracts are widely commercialized on the EU market as foods or as herbal medicines. When they fall under the condition of “herbal medicine” meeting the criteria of traditional use, then they can undergo a simplified registration process (THMP). Another story is when they are identified as food: the use and health claims authorization is managed by EFSA.
In particular, The Claims Regulation confirms that health claims made on botanicals can be authorized by EFSA only after a high standard scientific dossier which includes human intervention studies (2). For instance, it is commonly well known that EU nutrition and Health Claims Regulation prohibits health claims on food supplements, unless supported by high scientific quality and assessment. EFSA proposed and developed some methodologies in order to help manufacturers to pursue Health Claims for their ingredients, but those are effective only for the classic and generally recognized science, for instance minerals and vitamins.
In this scenario, Botanicals Health Claims have been put on hold directly affecting customers and industries. From one side, consumers’ perception around botanicals is really positive and it includes ingredients often associated with wellness, cognitive health and energy support (3). From the other side, the push for innovation from companies is stuck: industry is not able to properly share the value of their ingredients to final consumers by using appropriate Health Claims, even though their strong interest. Nowadays, what industries are asked to give is excessively restrictive and demanding, eventually limiting companies’ aspirations. In fact, following the great feeling exerted by botanicals, industries are now synergically combining those extracts with functional ingredients already supported by a strong science behind (3) to obtain claims assignation.
Certainly, assessing quality with proper science is fundamental and should be performed through an appropriate evaluation of the nature of the extracts and their effects on human health. Indeed, botanical extracts should be manufactured to augment the percentage of the desired components, decrease the amount of impurities, and improve the shelf-life, but overall, they need to be studied deeply in order to produce consistent material for health claim evaluation. Quality for sure is crucial and consumers are more and more aware of the importance of traceability, absence of pesticides, heavy metals and other impurities. In addition to this, many determinants can influence the final composition of a botanical extract. First of all, the solvent, the temperature, the duration of the extraction process and the following dry process. Secondly, it is fundamental to consider that between the same kind of plants, there can be variations due to genetic factors and environmental conditions (4). Moreover, in order to properly build an efficacy dossier positively evaluated by EFSA, studying the mechanism of action and adding clinical data is fundamental.
In addition to this, and following society goals, it is becoming increasingly important to progress with a manufacturing process that follows the sustainability path. The Directive on corporate Sustainability Due Diligence, adopted on the 23rd of February 2022, asks large companies to implement responsible practices in order to live in harmony with nature (5). For botanical extracts, this is critical: industries should aim to obtain their actives trying to adopt upcycling process to all those by-products that would generally be considered as non-valorized surplus from other industries (for example the food industry). This for sure could represent an added benefit for consumers and, companies should extensively start following this responsible path. It should also be taken into consideration that the population might not be enough informed on this topic and could see this effort only as a greenwashing activity. A proper working method should be focused on proof-based statements.
If the health-claims status has been put on hold, the growth potential for the self-medication or preventive segment is very much higher and faster than the one represented by common drugs. For sure, after pandemics, people are more sensitive towards their health status and they are constantly looking for daily food supplements capable of improving and promoting their quality of life.
The Food Supplement Market, as stated by IQVIA, is valued of $ 130 billion worldwide, and in the last twelve months, people relied on them in order to maintain their overall health status, improve their immune system or achieve a good energy balance (6). Moreover, sales for botanicals were expected to be of $ 38.9 billion in 2022 with a projected CAGR of 3.9% through 2024. This growth percentage is even stronger in the U.S.: 5% in 2023 and 6.3% in 2024 (7). There is definitely space for innovation, - but is it really possible to match the fast need of innovation with the intensive and expensive requests of EFSA in terms of scientific dossier to assess health claims?
Certainly, there are some hot-areas where companies should invest intensively in the next years, proposing innovative botanical extracts solutions to the market and to consumers.
Looking at Euromonitor, most supplement categories show negative constant value growth in 2022. In particular, consumers are looking for supplements able to improve their lifestyle: the focus is on mood/relaxation as well as eye health, women’s health and digestive health.
Peculiarly, women are responsible for 70/80% of general purchasing decisions, deciding what kind of foods, supplements and healthcare product to acquire. Women for sure are highly sensitive consumers, and this represents a great opportunity for manufacturers as traditionally studies were performed in men and women have been under-represented. Having said that, women’s health is a rising star category with a CAGR of 7.5% (2017-2022), but there are still lots of unmet needs: endometriosis support among the others, but also menopause, premenstrual syndrome (PMS) and vaginal health.
Sleep and Mental Health are also another hip here now: in the last years, the number of people manifesting stress-related problem has terribly increased. Stress and sleep are the most fast-growing supplement segment globally and it’s driven by the consumer’s concern. For instance, in 2022 35% of Europeans told that they have sleep related problems and the segment grew 14,9% in 2022.
As it was said before, the pandemic has incredibly boosted the digital transformation leading to a massive usage of electronic devices which are directly linked to eye health (CAGR 6.4%; 2017- 2022). UV and Blue lights can progressively damage the tear film normally lubricating eyes, causing annoying symptoms related to the dry-eye pathology.
In all of these areas, new ideas and effective botanicals are required. Why not to offer a natural-support solution to all of these conditions? (6).
To sum up, Health Claims are really demanding for all kinds of industries, starting from small companies to biggest ones and this is very much limiting companies’ aspirations and consumers’ benefits. Looking at the new trends and in order to innovate the market it will become more and more important to proceed it will be fundamental to be more flexible on the claims attribution.
R&D Manager - Bionap
Scientific and Marketing Director - EPO
Head of Scientific Communications & Marketing - Euromed
CEO - Fermedix
R&D Coordinator - FLANAT Research Italia
Data Analyst - FMCG Gurus
CSO - Flytexia
Scientific Manager - Flytexia
Product Innovation and Development Manager - INDENA
Senior Research Manager - INDENA
Junior Product Scientist - INDENA
Medicine Hunter - KSM-66 Ashwagandha
Alessandro Giuseppe Tricomi
Food Supplement Manufacturing - Natural Ingredients Solution
Quality Control - Natural Ingredients Solution
Market Manager, Nutraceutical – ROELMI HPC
General Secretary – S.I.Fit. (Italian Society of Phytotherapy)
Associate Professor in Organic Chemistry - University of Milano-Bicocca
Associate Professor in Organic Chemistry - University of Milano-Bicocca
References and notes
- COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION of the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods
- Food Institute Consumer Interest in health wellness boosts botanicals (website)
- Frontiers in pharmacology - Understanding plant to extract ratios in botanical extracts
- Vitafoods Insights - What does the nutraceutical industry really think of the EU Directive on sustainability?
- IQVIA and Pharmaline Data
- Natural product insider - Herbs and botanicals meet blended demands of traditional wellness and validated efficacy – analysis