It is feasible and safe if the basic rules are followed to the letter.
Steps to follow
- Identify exactly what you are looking for in terms of health benefits
- Read the descriptive sheets of our products that will give you the necessary basis to identify those that act on the health contribution you are looking for.
- Subsequently and most importantly,consult the Health Canada nomenclature that is available on our site for each of the medicinal products we offer. You will first find the recommended uses that Health Canada accepts and from there, evaluate if it is a medicinal ingredient that should be part of the individualized product you want to develop.
- If so, caution should be exercised. First look at the same Health Canada fact sheet for the risk statements of the product and check if this medicinal ingredient does not go against certain health problems you suffer from and also the possible allergies of its consumption.
- And if once again everything goes well, go to the most crucial step, that of the safe daily dosages appearing on Health Canada’s nomenclature sheet. Just don’t go beyond them.
- You must follow these steps for each of the ingredients you will use in your formulations that you want to adapt to your needs.
Concrete example of the development of a product. Our own formulation « Sexual Wellness », an amalgam of ginkgo biloba, maca and rhodiola rosea, three medicinal ingredients renowned for their aphrodisiac effects.
As noted elsewhere on the Site, Health Canada does not recognize, with the exception of maca, any relationship between these products and their ability to influence libido. On the other hand, for those who believe there is a foundation, they can develop a product accordingly as long as it meets Health Canada’s requirements. For us, who have a marketing license and sell our products in pharmacies and natural health stores, we must write on the packaging of the products:
– recommended uses
– the permitted dosages
– mentions of risks
– our Health Canada license number, our addresses, and finally the information you find on each package of this type of product.
In this case, theonly mention making a link between our BES product and libido is that of maca: « Helps support the emotional aspects of sexual health ». Without maca, no link with sex would have been allowed.
So let’s go step by step:
Identification of medicinal ingredients to be used
We first did an exhaustive study of products known to act on libido. Of a list of more than 100 ingredients, only the consumption of a few is permitted in Canada. Our list has been shortened by the same amount. Finally, products that are not plants, such as velvet wood and those that are allowed but with very restrictive restrictions, were rejected. Same with products considered as food and sold in grocery stores such as cayenne.
The products we have selected for our short list are the best known and most used: maca, gingko biloba, rhodiola, panax ginseng (Asian ginseng), quinquefolius ginseng (5 stars/ American ginseng) and artichoke.
Of these three medicinal ingredients, we have chosen maca as the main product of the Sexual Wellness formulation. Firstly because maca is one of the most recognized products for this purpose but also because it allowed us to write on our labels a claim referring to sexuality.
When making a mixture of medicinal ingredients, only the recommended uses and purposes of the ingredient retained as the skeleton of the product can appear on our labels. In the case of Formula BES, these are those of maca because we can not combine the uses of the three products. We must stick to one. Here are the uses recommended by Health Canada for maca and therefore for our BES product:
- Helps support the emotional aspects of sexual health
- Helps maintain a healthy mood balance during menopause
- Provides antioxidants
Subsequently, we listed on our labels all precautions, warnings, contraindications and adverse reactions listed in the nomenclatures of maca, ginkgo and radiole. In fact, Health Canada limits the medicinal benefits to one product but requires that all restrictions of the products used appear on the label of natural health products. We have therefore listed all the possible disadvantages of the three products combined, namely those of maca:
- If you are pregnant or breastfeeding, consult a health care practitioner before using it.
- If you are taking blood thinners, consult a health care practitioner before using them
- If you are taking antidepressants, consult a health care practitioner before using them
- If you have a psychological disorder or illness, such as frequent anxiety or depression, consult a health care practitioner before using it
Those of Ginkgo biloba:
- Consult a health care practitioner prior to use if you are taking medication for diabetes, high blood pressure or seizures
- (contraindication) Do not use if you are taking health products that may have an effect on blood clotting (e.g. anticoagulant agents, replacement therapy with clotting factors, acetylsalicylic acid, ibuprofen, fish oil, vitamin E); these products may increase the risk of spontaneous bleeding
And finally those of the rodiole which are not found in the monograph of the first two products are:
- If you are taking hormone replacement therapy or if you are taking oral contraceptives, consult a health care practitioner before using them
- contraindication:Do not use if you have bipolar disorder or bipolar spectrum disorder (Iovieno et al. 2011; Winston and Maimes
- known adverse reactions: If you have irritability or insomnia, stop taking the product
- To complete its development, we moved on to the dosages allowed by Health Canada and once again retained according to their guidelines, the most restrictive are:
- Maca:3 – 3.5 Grams per day, dried root/hypocotyl or equivalent
- Ginkgo biloba:4 – 12 Grams per day, dried leaves
- 22-27 Percent Flavoglycosides
- 5-7 Percent Terpeno-lactones
- Rhodiola rosea (rhodiola); Up to 600 mg of rhodiola extract per day, not to exceed 200 mg per single dose (EMA 2012; Pizzorno and Murray 2006).
The final step
The final step was to check whether the mixture of these three products was acceptable and fixed the quantities of each of the medicinal ingredients of the formulation while respecting the restrictions in their entirety. Also, we wanted to avoid taking huge amounts of capsules per day. This is what limited the dose of rodiole to 200 milligrams because Health Canada requires that each dose be limited to 200 milligrams per dose. To reach the maximum allowed of 600 milligrams/day, we should have recommended taking one capsule three times a day.
Our final formulation was therefore to put in each capsule:
- Maca 300 milligrams of powder at 10:1 concentration (concentration of the Naturex powder used) or 300 mg X concentration 10:1 for a total of 3 grams which is within the permitted limit of 3.5 grams / day.
- Gingko biloba:115 milligrams of powder at a concentration of 52:1 (concentration of naturex powder used) for a total of 5.98 grams of equivalent gross amount which is within Health Canada’s permitted limits of 12 grams/day. The reason for this limitation is that for 6 grams and more / day, we should have advised on our label that if the use continues more than 4 weeks, consult a health practitioner. On the other hand and if this requirement does not bother you, you can take, in addition to a capsule of the BES Formulation, a capsule or two of our Maca Formula containing the equivalent of 3.0 grams per day. In fact, you can take one capsule of BES Formula providing 5.98 grams/day, plus two capsules of our 10:1 ratio maca powder. The result would be the initial intake of 5.99 milligrams of the BES formula + 2 capsules of maca 10:1 each providing 3.0 grams which will total in total (5.99 grams + 2 x 3.0 grams = 6 grams) 11.99 grams which is below the allowable limit of 12 grams / day required by Health Canada.
Any questions? Do not hesitate to ask us or participate in our BES blog and discuss them among yourselves.