Panel discussion on...
Insights on botanicals’ quality control/assurance and health claims
In the field of botanical extracts, notions of quality control and assurance are broadening as we gain a greater understanding of what constitutes good practices and quality botanicals. Today we understand that a great many factors are involved, from cultivation and/or wild harvesting to analysis of final products.
Cultivation of plants must be conducted by safe and environmentally friendly means, not only to support a healthy environment and protect people who work with plants, but also to produce final extracts that are not contaminated by potentially dangerous agri toxins.
In the case of wild harvesting, guidelines of sustainability dictate that no endangered plants will be used, and that any harvesting activities leave a minimal environmental foot print.
Proper identity of plants, via TLC and other methods, ensures that the right plant and plant part are being used. Since there is much adulteration and mis-labeling of botanicals in today’s botanical market, this is a critical step.
Extraction is like cooking. You don’t boil toast, and you don’t fry a salad. In the case of each botanical, one method will be superior to others in terms of yielding a high quality extract. This is one area in which scientific knowledge plays a key role. The various constituents in specific botanicals dictate whether alcohol/water extraction, water-only extraction, CO2 extraction or freeze drying will yield the optimal final material. This depends on the phytochemical composition of the plant in question.
Resulting extracts, if standardized, should be concentrated to a specific level of those constituents deemed “active,” with all other constituents in the plant present in their natural balance. Most plants contain hundreds of compounds, and while we have ample evidence that “whole” extracts which contain all the constituents of a plant or plant part except water are healthful, we have scant evidence that fractionated or highly purified extracts offer similar benefits.
Traceability through the entire process of botanical production is essential in order to know a botanical extract and what has happened from field to finish. Today the market demands more than a percentage number for an extract standardized to one or more natural constituents. Demand for sustainably produced botanicals is significantly on the rise. Analysis of a botanical, from its natural condition after harvesting right through to final product is essential to ensure safety, purity and potency.
Regarding health claims and applications, we have seen an increase in the demand for minimum intake doses in the industry, especially with certain delivery formats. It makes sense for delivery formats such as gummies where you have a limited amount of ingredients you can load into it, but not for more traditional formats like capsules and tablets. Our expertise is KSM-66 ashwagandha. We have seen in the field of ashwagandha some suppliers who make the extract using the plant’s leaves instead of just the root to spike the withanolide content to help keep the daily dosage low but actives high. In light of the ever-increasing demand for ashwagandha and the surging market potential root-based formulations command a much higher premium than those with leaves. Therefore, supplement companies looking to capitalize on consumer demand for root-based formulations, while also saving on expenses by using cheaper root & leaf-inclusive extracts, can turn greater profit. This is an unfortunate trend as it causes high levels of Withaferin A to now be in the extract which is known to be cytotoxic. Thousands of years of practice and hundreds of clinical trials have shown that the roots are responsible for the therapeutic effects of ashwagandha, not the leaves. Incorporating leaf material (and other aerial parts) undermines the efficacy of ashwagandha, devalues the hard-working ashwagandha farmers, and places consumers at unnecessary risk. It is therefore important to make sure that the ashwagandha extract is drawn from roots alone and that leaf components are not added. The drive for lower dosing instead of effective dosage at a lower cost may in the end hurt more than help.
When it comes to the current models of human intervention trials, in our opinion, we believe that the gold standard of human clinical trials should be used, which is double blind placebo controlled. These are more costly, however worthwhile to prove efficacy and build trust for botanicals. It is also important to collaborate with major academic and research institutes. Also make sure that the clinical studies are published in high quality, high credibility outlets like PubMed journals. PubMed is an index, maintained by the U. S. Government’s National Library of Medicine, of peer-reviewed articles published in what academics consider to be high-quality biomedical journals.
Some botanical makers’ clinical studies try to show the effectiveness of their botanical by demonstrating improvement in clinically compromised populations or otherwise less than fully healthy populations. However, if your finished product is targeted toward normal healthy populations, this is very problematic because clinically compromised populations are systematically different from normal healthy populations and, therefore, demonstrations of improvement in clinically compromised populations may not hold true for normal healthy populations. Broadly speaking, because of the physiological law of diminishing marginal improvements, it is easier for a drug or ingredient to achieve improvements in clinically compromised populations than in normal healthy applications: for example, it is relatively easy for an obese person of weight 130 Kg to lose 3Kg than it is for a healthy person of weight 75 Kg to lose 3Kg.
Furthermore, a botanical must be properly identified, using the correct part or parts, handled according to good GMP's, never ever adulterated with any incorrect plant parts or drugs or chemical agents either declared or undeclared, prepared into an extract or other form in a clean and well-run facility, without the use of so-called exotic or hydrocarbon solvents, and often standardized to a specific level of key active phytochemicals. At various steps of the chain the botanical(s) should be tested for identity, concentration of actives, microbes, pathogens, chemicals, pesticides, and heavy metals.
These days we see an ever-greater bar emerging. Ideally a botanical will be organically grown, its trade will involve good wages and conditions, extraction will be performed utilizing clean and green technology and its trade will include benefit sharing with originating communities and people.
The 50,000 or so botanicals known to enhance health are utilized for virtually every conceivable health need with no exceptions. Whether you seek remedies for headaches, constipation, bad breath, nervousness, ringing in the ears, joint discomfort or grave life-threatening conditions, there are botanicals utilized for all those needs. Botanicals can also enhance overall energy, endurance, stamina, alertness, concentration, relaxation, sleep, strength, coordination, boost mood, and much more. There is no single category for botanicals and their benefits.
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
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- Lombardi N et al., British Journal of Clinical Pharmacology, 87(3), 741-753
- Ivanova Stojcheva E etal., Molecules 2022; 27(12):3902.