Panel discussion on...
Julián Castillo Sánchez
Principal Scientist & Technical Fellow, iff, Spain
The plant world is a world of opportunities, in that it provides nutrients and numerous molecules to be used in the world of health, and this wealth of potential solutions requires responsibility in how we source, extract and produce these elements, sustainably. Evolution, science, and regulation have led us to establish boundaries and guidelines, which broaden the use cases of botanical ingredients in nutritional supplements, nutraceuticals, functional foods, cosmeceuticals, medical nutrition and pharmaceutical applications.
Consumption of botanical ingredients is growing worldwide. According to Indena, the recent pandemic situation has contributed to an increase in the market volume of food supplements. In 2022, the global market for food supplements is approximately 145 billion euros with an annual growth of more than 8%. However, FMCG Gurus has also said that while botanicals are associated with multiple benefits, some consumers can be skeptical of the claims made on products containing such ingredients. It is necessary to clearly define what consumers expect from the consumption of botanical ingredients, what does ‘health and well-being’ really means to them, and what the industry and the authorities must do to fulfill these expectations. Indena perfectly captured this consideration in their assessment on a suitable model “to succeed with the right balance between effectiveness and “product sustainability”.
Importance of botanicals integrity
The potential of botanical health ingredients depends on the overall quality of the raw plant material used in its manufacture. Firstly, safety considerations. KSM-66 Ashwagandha stated that cultivation of plants must be conducted by safe and environmentally friendly means, and final extracts must be produced in a way that are not contaminated by pesticides and potentially dangerous agritoxins.
Secondly, an important factor to consider is a consistent source of supply of bioactive compounds. We know that a plant material is, as pointed out by EPO, an extremely complex matrix containing countless chemical compounds. This mixture is referred as ‘phytocomplex’ and contributes to its biological activity. Euromed added that “botanicals must be grown, harvested and verified properly to preserve plant integrity and bioactive profiles”.
I do agree with these considerations. However, I want to highlight a critical point raised by several panelists: a well-defined and constant composition of the starting material is one of the most foundational prerequisites to produce consistent, good quality and replicable extracts.
If this was always the case, counterfeiting of these botanical ingredients can be prevented. To achieve consistent product efficacy and safety, the industry must employ a flexible technological capacity. It is increasingly necessary to accurately quantify the active principles and contaminants that are present in botanical raw materials. Additionally, analytical controls are necessary to prevent possible adulteration processes. With the latest advances in analytical techniques, it is possible to investigate the raw material to control and identify adulteration. As Bionap reported, ”DNA analysis must be complemented by High Performance Liquid Chromatography (HPLC) and High-Performance Thin Layer Chromatography (HPTLC).”
Science behind extracts
Based on the above considerations, Bionap and other panelists commented that climate change may impact the quality and availability of plant materials for botanical extracts. ROELMI stated that “the Directive on Corporate Sustainability Due Diligence‒adopted on 23 February 2022‒asks large companies to implement responsible practices to live in harmony with nature. For botanical extracts, this is critical”.
Another notable key factor is the optimization of the extraction process: How to combine efficiency in the extraction with the sustainability and consistency of the process itself? Common industry extraction practices include solid-liquid extractions by maceration, percolation and CO2 extraction. There are also new ways of providing energy to the extraction process such as current pulses, microwaves, ultrasound, crystallizations, molecular filtrations, exchange resins etc. Currently, hydro-alcoholic extractions (ethanol - water) predominate. There is a certain tendency/mentality towards extracts using water only. As KSM-66 Ashwagandha pointed, “This is one area in which scientific knowledge plays a key role. This depends on the phytochemical composition of the plant in question.” Euromed added that it also depends on the plant, its active compounds and type of extract required.
That is the key point: what is our purpose? Are we looking for an extract that integrates all the ingredients of the plant? Or are we specifically looking for certain compounds that are present in it? EPO's comment presents the most suitable explanation: two different schools of thought: one closer to favor the extraction of a marker until an almost purified extract is obtained, and one closer to the herbal tradition prioritizing the preservation of the plant phytocomplex; “there are, of course, many intermediate possibilities between these two extremes.”
There is accumulative, rich knowledge and extensive experience in the ethnobotanical study of medicinal plants. And this serves as a great starting point and reference to assess their potential health efficacies. Most plants contain hundreds of compounds. KSM-66 Ashwagandha commented that while there are ample evidence that ‘whole’ extracts which contain all the constituents of a plant or plant part‒except water‒are healthful, there is scant evidence that fractionated or highly purified extracts offer similar benefits. In my opinion, there is (little) evidence for greater benefits too. Science must speak and act in this dichotomy especially considering the changes in the legislative and regulatory framework.
Quantifying an extract
The third factor is the botanical extract itself. For a long time, the general assumption is that chemical fingerprinting is regarded as the minimum standard for quality control of a plant extract. The analysis of chemical markers or specific constituent(s) in the plant can help identity, guarantee genuineness and the quality of a good herbal preparation.
As highlighted by SIFIT, the quality of herbal products is a very fascinating, yet demanding subject. A chemical qualification needs to be provided for all marketed botanicals. There is no exception. No chemical characterization means no quality, it’s that simple. EPO reminded that the choice of markers is generally based on literature data and official texts, and “the chosen markers, when possible, must relate to the “known therapeutic activity” of the botanical ingredient.” This emphasizes the need for further study and assessment of the dichotomy between the phytocomplex and specific active compounds.
Euromed wrote that “quality control of botanical products requires the most up-to-date analytical techniques, such as HPTLC, HPLC and gas chromatography (GC)” to avoid misidentification of plants, lack of standardization, contamination, unintentional comingling of different plants causing adulteration, failure of good manufacturing practice, and incorrect preparations and/or dosages, “as well as the quality and safety as for the impurities and contaminants”. In this regard, it is evident that botanical extracts are subjected to a gigantic conglomerate of regulations, each with its own unique requirements.
Safety and regulatory framework
Natural Ingredients Solution commented that consumer safety has been the reason behind the constant regulatory update of the food chain. Is the regulatory framework adequate? Is it enough? Is it scarce? Or is it reasonable or exaggerated? Botanical extracts in their food applications are considered as food and, as such, are subjected to EFSA restrictions. Can a product that is ingested at 250 mg/day be quantitatively regulated in the same way as another that is ingested at 250 g/day? The difficulty in responding to this approach is understandable. Since it is a question of consumer health, the food regulation in force would seem to be appropriate and adequate. And increasingly stringent restrictions may arise in the future, which could limit innovation in this regard, commented Natural Ingredients Solution.
If an extract (its active compounds) has to be effective as a preventive health agent, it is essential to consume it in a minimum amount. There is a growing trend towards alternative delivery formats for botanicals beyond tablets and capsules, and we can evaluate the suitability of botanicals for other formats such as gummies, powders, drinks etc. FMCG Gurus wrote that “research finds that nearly 90% of consumers prefer functional food and drink over nutritional supplements. Despite this, the preferred supplement format is still capsules (67%)”. On the other hand, the formulator's challenge often lies in creating a real functional food that not only has nutraceutical benefits but is also appetizing, commented Natural Ingredients Solution. “The nature of the actives present in the extracts plays a fundamental role.”
Health claims and applications
KSM-66 Ashwagandha confirmed that in regard to health claims and applications, they have seen an increase in the demand for minimum intake doses in the industry, especially with certain delivery formats. It’s the manufacturers’ responsibility to ensure the minimum amount of active compounds are met to suit various delivery formats, and to not lower it for technical, cost, or organoleptic reasons.
Another last but very important aspect‒clinical research. Clinical trials, which are based on previous in vitro and preclinical studies have become the gold standard to justify the health benefits of botanical ingredients. “The length of clinical interventions may rely on the biological/physiological functions and their up/down regulation potentials," said Fytexia. It's important to remember that sometimes we are in a certain nebula regarding the use of nutritional supplements as preventive agents or aids in maintaining normal health. It is hence crucial to carefully design these clinical trials and select volunteers, including considerations such as trials conditions, placebo group, and double-blind protocols etc.
KSM-66 Ashwagandha's comment is clear and precise: ”clinically compromised populations are systematically different from normal healthy populations. Therefore, demonstrations of improvement in clinically compromised populations may not hold true for normal healthy populations”.
It is very important to correctly define the scope of use for botanical extracts by establishing the basic criteria to determine if a botanical extract is suitable for use as a ‘nutraceutical’ or as an ingredient in medical nutrition. The latter poses serious difficulties when comparing the nutraceutical application with the potential use in medical nutrition of a botanical extract. “For medical nutrition, it is strongly important to demonstrate the nutritional value of a botanical bioactive to justify their role in rebalancing the dyshomeostasis occurring in disease development. Unfortunately, so far, most of the bioactive from botanical extracts are still not considered by health/regulatory authorities as nutrients; it’s a future challenge on polyphenols,” said Fytexia.
Efficacy to deliver health benefits
Very recently, there have been recommendations (reviews and meta-analyses) on the minimum effective intake doses of botanical extracts required to achieve a certain level of health benefits. However, while scientific evidences suggest that certain dosages are necessary for optimal efficacy, there are new products developed that contain low dosages due to low cost constraints and safety requirements. This strategy must be responsibly evaluated, both from a scientific and regulatory framework perspective.
Health expectations cannot be managed with mere statistics. One of the main questions that science and the regulatory framework must address together is how to establish a relationship between the duration and dosage used in clinical trials, and the appropriate use of botanical supplements in a daily life. Bionap explained the correlation perfectly: because nutraceuticals/botanicals should be used by healthy people to maintain their health, the duration of treatment should be long (chronic treatments) and depends on the application tested. What’s worth mentioning is also a comment from Natural Ingredients Solution: active botanicals are used under the recommended dose but has a cumulative effect.
Promising role of botanicals
ROELMI wonders what the main health objective of botanicals is. “Nowadays, consumers are looking for supplements that can improve their lifestyle. Their focus is on stress, sleep mental health, mood/relaxation, eye health, women’s health, and digestive health”. And Fytexia believes that the main role of botanicals is to keep a balanced state among all the body systems needed for the body to survive and function correctly which otherwise could result in obesity, cardiovascular health and affecting general wellbeing etc.
A final consideration. Most of the ‘drivers’ that shape the food industry are focused on addressing multifactorial issues that affect a diverse range of biological targets like: cardiovascular disease, metabolic syndrome, digestive wellbeing, obesity, joint pain and stress/sleep. Similarly, various life situations – from work stress to menopause and aging -- that we encounter at different stages of our lives can affect a wide range of biological processes and are also multifactorial.
Therefore, enhancing metabolic resilience is an effective way to prevent the onset of pathologies increasing the organism’s capacity to restore physiological processes to a normal, stable but dynamic state following exposure to stress or specific challenges. This approach involves the combination of a set of bioactive ingredients in the same food that act in harmony to maintain homeostasis. A multifactorial approach allows the development of new products/blends that may be more effective in preventing these imbalances, simplifying the consumer's choice, providing new commercial arguments, and, ultimately, allowing the food industry to grow.
References and notes
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