Quality as a guideline in choosing
food supplements of botanical
origin, recommendations from a
new advisory board, with a
focus on turmeric
The botanical supplements sector comprises a huge range of products which vary significantly from one to another, not least for different degrees of attention and transparency given to quality and safety. This is why for doctors, pharmacists and consumers alike, quality should be a defining criterion in the choice of supplement and an essential requirement for information and transparency.
What do we understand by quality supplements? What elements allow us to evaluate the quality, safety and efficacy of the products? What are the risks of “do it yourself”? What are the criteria for the correct use of food supplements? How should proper information be provided?
Such questions make sense mainly considering that, according to recent data from the Italian market, 32 million people use food supplements, and 18.7 million of them are regular users.
Consumption transcends gender, age and geographical area in a sector which includes a vast quantity of very different products, whose degrees of attention and transparency as for quality and safety aren’t always the same and are not always easy to comprehend.
Answers need to come from authoritative experts. That’s why an Advisory Board on Quality in Food Supplements of Botanical Origin has been recently established: a multidisciplinary panel of Italian and international experts with different specializations, chosen from the leading authorities on botanical extracts, dedicated to point out the concepts of quality, efficacy and safety of botanical supplements in order to supply doctors and pharmacists, but also consumers, with clear guidelines on how to choose supplements that offer guarantees about those aspects.
The Advisory Board, created on the initiative of Indena (a leading company in the production of quality botanical ingredients), and of Scharper (a pharmaceutical sister company also with a history of development and marketing of food supplements promoted exclusively to the medical profession), issued on January 2020 the Consensus Paper Food Supplements of Botanical Origin: a Multidisciplinary Approach to Quality. The case of Turmeric to clarify what is meant by quality supplements. Careful analysis of scientific literature and the comparison of clinical practice experiences were the basis of the joint work that led the group of experts to formulate the indications and recommendations contained in the Consensus Paper.
The document has received the backing of the Italian Society of Nutraceuticals – (SINut), an independent non-profit association which undertakes to develop, encourage and promote nutraceutical research.
What does quality of botanical extracts exactly mean?
The first question is related to what “quality” is expected to mean, mainly considering that it may often be confused with other concepts, like safety and efficacy.
- quality is determined by the characteristics of the raw material, the supply chain, the technologies and processes used for the processing of the ingredients, the controls on the production of botanical ingredients and the finished product;
- safety is primarily linked to the verification of the absence of potential contaminants typical of products of plant origin, an aspect that pertains to quality, but also to the specific conditions of the organism that assumes the supplement, the dosage and the methods of intake and the possible interactions with other active ingredients, be they natural or synthetic. Therefore, it is essential to carry out preclinical toxicological studies to guarantee the use of the botanical ingredient. However, a quality supplement can have different safety profiles in different subjects and for this reason it is advisable that the intake of botanical supplements is preferably recommended and guided by the doctor or pharmacist;
- efficacy is understood to be the ability of a supplement, through its ingredients, to strengthen physiological processes: supplements containing the same ingredient of natural origin can have different effectiveness depending on the formulation, which for example modifies its solubility.
Considering the mentioned rationales, it’s important to remind that a supplement of quality can be recognized, mainly with the expertise of a doctor or pharmacist. Prescribers can request information to evaluate the quality and safety of products, transparency on the production chain, from the raw material to the finished product, and scientific evidence such as preclinical, clinical, pharmacokinetic studies on botanicals.
The awareness in the use of supplements is very important as well. A “do-it-yourself” approach in choosing and assuming food supplements is quite widespread among the people, who consider natural products “in themselves good”, and who are able to access easily those products in the market. On the contrary, the use of supplements of botanical origin requires an overall assessment of the individual’s condition, any possible interactions between the active ingredients contained in the supplements in question and other drugs or supplements the individual may be taking: skills which only doctors and pharmacists possess.
How could prescribers and consumers concretely recognise quality, efficacy and safety of a supplements of botanical origin?
Quality of botanical supplements starts from the quality of raw material, that implies: identification of the plant with certainty, through specific protocol and analyses (i.e. botanical checks, chromatographic profiles, or DNA analysis), purification of the botanical extract from notoriously toxic or allergenic or unwanted substances, standardization. Other important aspects are the control of the supply chain and of the quality of the manufacturing processes. As for efficacy, despite current legislation on botanical supplements does not require evidence of efficacy based on scientific studies, there are supplements of botanical origin whose effectiveness is demonstrated by rigorous preclinical and clinical studies and conducted with methods similar to those required for drugs. To verify the efficacy of a product with respect to the physiological function it claims to have, it should be checked the availability and the reliability of specific preclinical and clinical studies on the ingredient, the pharmacokinetic results from studies dedicated to the specific product with its specific formulation and the evidence of clinical studies on healthy physiological activities.
An essential aspect of safety is interaction. The use of supplements of botanical origin requires an overall assessment of the condition of the person concerned, with a technical competence that can only be provided by a doctor or pharmacist.
Botanical ingredients have physiological effects which must be known and assessed with respect to the specific situation of the individual for whom they are intended, also considering any possible interaction with any other active ingredient the subject is taking simultaneously, whether natural or synthetic.
In a few words, botanical supplements should be prescribed or recommended with the same rigorous approach applied to all prescriptions.
Focus on turmeric
Turmeric is the case study presented in the first Consensus Paper issued by the Advisory Board on Quality in Food Supplements of Botanical Origin. According to IQVIA data, 4.9 million packs of supplements containing turmeric were sold in Italy from July 2018 to June 2019. Turmeric is also one of the world’s most widely studied botanical extracts: as of 2019, about 100 human studies have been carried out on curcumin, involving thousands of subjects.
Curcuma longa L. (a member of the ginger family, Zingiberaceae) is a perennial herb plant widespread in South East Asia and extensively cultivated in China, India, Indonesia and Thailand. Turmeric’s iconic colour derives from three chemically distinct compounds, which are the active components of the plant: curcumin, demethoxycurcumin and bisdemethoxyurcumin. Although often collectively called curcumin, these curcuminoids have different chemical personalities and colours and, working together or individually, have been shown to produce important physiological antioxidant, anti-inflammatory, anti-mutagenic, anti-infectious and anti-cancer effects.
The quality of turmeric, like all botanical extracts, depends primarily on the quality of the raw material and the purity of the extract. The procedure that enables the plant to be unquestionably identified is by DNA analysis or barcoding of the plant itself. Furthermore, quality turmeric is free from contamination, whether accidental or deliberate. Moreover, raw material’s manufacturing process has to be strictly controlled to avoid any potential contamination along it. As for safety, the scientific evidence shows that the safety profile of turmeric is very high.
Recognized for its antioxidant effects and its osteoarticular function, turmeric has been the subject of human studies that have demonstrated its anti-inflammatory function, through which it contributes to maintaining gastrointestinal, cardiovascular, osteoarticular, and liver health.
Nevertheless, like many botanical ingredients, turmeric has poor solubility in water and it’s not easily absorbable by the intestine, with consequent limitation of its bioavailability.
To face such an issue, Indena developed one of the most innovative solutions: Phytosome®, a formulation using 100% food grade ingredients (lecithin) and able to optimize the bioavailability and pharmacokinetic profile of active compounds of natural origin.
Indena’s turmeric extract formulated with Phytosome® is Meriva®, whose efficacy is demonstrated by 35+ scientific studies in humans, of which at least a third were conducted with the randomized controlled scheme, relating in particular to the areas of cardiovascular, intestinal and ocular health, nutrition in sports, joint health and supportive care. In these studies involving over 2000 subjects, no serious adverse reaction has ever been reported.
1 https://www.federsalus.it/wp-content/uploads/2019/06/Rapporto-Censis-definitivo-1.pdf; http://www.censis.it/welfare-e-salute/salute-gli-integratori-alimentari-utilizzati-da-32-milioni-di-italiani
2 “Guidelines on studies conducted to evaluate the safety and properties of food products” Rev- November 2018
3 Arrigo F.G. Cicero, “Turmeric supplements: what you should know”, article on the Federsalus website, 31/7/2019, https://www.federsalus.it/integratori-di-curcuma-cosa-sapere/
4 Attilio Giacosa, talk at the Assoerbe convention, InVitality 2019, Milan 21/11/2019