Expert opinion on the toxicological aspects and risk assessment of the product VIRALIS, a dietary supplement created to help boosting the immune system based on herbal components. The product is meant to help regulate the level of response of the immune system of healthy subjects. There are warnings concerning the use of VIRALIS by subjects taking prescription medicines.
This initial review relates only to the toxicological aspects and risk assessment of the substances used in the formulation of VIRALIS, a dietary supplement produced by E.M.B. YARDENAGRICULTURALFARM LTD.1,HaomanBeitShemesh-99061 -ISRAEL.
This independent opinion has been done on the request of Mrs. Vered Gilad and Mr. Moshe Asher from GILAD -Health and Beauty Ltd. This independent opinion is confidential and shall not be used to promote the product to the general audience.
This independent opinion shall not in any way represent official permission to market the above-mentioned product, nor can be used as an expert opinion in court.
This document relates to the safety and toxicity of the product as of today. Namely, that it is Herbal extract concentrate in a bottle of IO ml produced in a GMP facility.
Dr. Yehoshua Maor
Expert in pharmacology, toxicology and regulation of medicines and nutritional supplements.
About my training:
• Bachelor’s degree in Pharmacy (B.Pharm , Brazil )
• Medicinal Chemistry degree (M.Sc., Hebrew University)
• PhD in Medicinal Chemistry and Molecular Biology {PhD, Hebrew
University)
• Post -Doctoral School of Medicine and Harvard University, Boston, USA, on Pharmacology of cardiovascular
• Coordinator of the Center of Excellence for Research in Agriculture and
Environmental Health of the Hebrew University of Jerusalem (HU CEAEH) in the Rehovot campus and lecturer of Toxicology at the Faculty of Medicine in the Ein Kerem campus -Jerusalem.
• Senior consultant at Phytor Ltd. Engaged in consulting in pharmacology,
toxicology and regulatory aspects of new drugs and chemical substances of medicinal plants.
• Member of the SOT (Society of Toxicology)
• Member of the ICRS (International Cannabinoid Research Society)
After thoroughly reviewing the scientific and professional literature, this document will refer only to the following subjects relating to VIRALIS product components:
1. The amount of active substance in the plant before and after extraction
2. Reaction between components
3. Usual doses and toxicity of formula or component
4. Warnings about the product
5. Levels of safety
1. Active substances in the plant before and after extraction
The amount of active ingredient in the plant before the extraction can vary with the harvest season, cultivation location, and other factors.
As for herbal medicines, the active ingredient is sometimes known and sometimes requires co – factors ( other materials in the plant that are active together synergistically) to achieve therapeutic goals. This leads to complications in tagging the active ingredient. One-way manufacturers have found to solve the problem of labeling is selecting the marker element (the most active component in the plant) and perform standardization of the cursor element.
However, official standardization by government agencies such as the Ministry of Health, has not been achieved yet, and therefore not required by the health of natural herbal products manufacturers in Israel or in Europe. Consequently, various companies use different markers, or different levels of the same markers, or different methods of testing marker compounds.
Both the Israeli Ministry of Health and EMEA/EFSA do not publish a list of active substances in plants. Instead, they provide a list of plants approved for use.
In order to compare the amount of active ingredient in the plant before and after extraction, we find that in the British Herbal Pharmacopoeia and – British Herbal Compendium doses comparing different forms of plants, such as root dry compared to the extraction liquid tincture.
2. Reaction between components
There are no reactions between the components used in the tincture process to prepare
VIRALIS
3. Usual doses and toxicity of formula or component
The recommended daily dose of the product allows the use of reasonable and absolutely safe margin of toxicity. In addition, VIRALJS can be safely administered up to 30 drops (1 ml) diluted in 100 ml of water 3 times a day for a healthy adult, without any fear of side effects or toxicity. The formula requires relatively large amounts the product in order to exhibit toxicological properties. To the best of my knowledge, from the toxicological standpoint, there is no fear of toxicity or poisoning from taking this product up to 10 ml/day in acute doses, but not chronically.
4.Warnings about the product
• Pregnant women, lactating women, patients taking prescription drugs, children should consult their family practitioner.
• VIRALIS is generally safe for healthy subjects who wish to boost their immune system with the aid of botanicals. However, if you are on any immunesuppressing mications, VIRALIS botanical components may counteract or reduce the effectiveness of these medications. These medications include corticosteroids (prednisone) and medications used to treat autoimmune diseases.
• VIRALIS might slow blood clotting. Taldng this formula along with anticoagulant / antiplatelet drugs might increase the chances of bruising and bleeding.
5. Levels of safety
Over 60% of the VIRALJS formula is based on 4 botanical sources. All of the components of the formula possess a high level of safety. However, due to the well documented immunostimulant effects, as precautionary measure, it is recommended not to consume VIRALIS before or following a bone marrow, or organ transplant or a skin graft as this may increase the chances ofrejection. VIRALJS botanical components may counteract or reduce the effectiveness immune-suppressing medications.
Based on a critical evluation of available public data sources listed in the bibliographic sources and above, as an expert in toxicology I have reached the conclusion that the active components used in the formulation of the product VIRALIS, is safe for human use especially when followed the instructions for use from the producer. The formulation possesses a wide safety margin concerning its risk of toxicity. However, it should not be taken chronically (over 9 months).
In conclusion, since the components used in the formula have been authorized for use as dietary supplements by the Ministry of Health and possess a long history of safe use for humans, the review of the substances and the product allows me to state that the product has a high safety level, once it is administered in accordance with the use and guidance of the WHO monographs for the components and therefore for the product.