More from the CHFA on NPN Licensing

Further to our last post about NHN quality in Canada – here are some details via the CHFA about how companies go about actually getting their licenses to sell NHP’s.

 

Ten-Day Licensing

Under the “Management of product licence applications for natural health products,” products eligible for approval within 10 days are part of what NNHPD considers Class I products.  To be eligible for this category, the product must comply with all parameters of an individual (a single) Health Canada monograph.

Monographs are documents developed and maintained by NNHPD that contain a compilation of the known efficacy and safety information of a certain well-known ingredient. The use of a monograph is efficient for both applicants and the NNHPD since the safety and efficacy of the ingredient has already been established by Health Canada when it is used under the conditions specified in the monograph.

Since the information needed to support the safety and efficacy has been vetted and is thoroughly understood, an applicant can attest to meeting the monograph for their product and the application is then reviewed for completeness. These applications are for the lowest risk, highest certainty products.

To add further scrutiny to the review, NNHPD conducts random and risk-based post-licensing audits of monograph-based applications.  This ensures that the parameters against which applicants have attested were met.

DNA Testing

Scientific developments in quality assurance testing and analytical methodologies continue to evolve worldwide. As new technologies are developed, those technologies may lead to new test methods and analytical procedures that are faster, cheaper and more precise. However, emerging test methods must be validated for accuracy and acceptability before being promoted for general use.

 

As an example, the use of DNA barcoding technology for testing the identity of botanical products is useful but presently limited. DNA testing is rarely able to properly identify chemically complex herbal extracts, as little or no DNA is extracted during the extraction processes. This technology would be more appropriate for raw material identification than herbal extracts found in finished products.

 

In the case of DNA testing specifically for finished products containing herbal ingredients, additional scientific analysis should be used to confirm the initial DNA results. Drawing conclusions on the basis of one testing technology from one laboratory should only be considered as preliminary and requires further substantiation.

 

Canada’s Natural Health Product Regulations reinforce that quality assurance and quality control are critical for manufacturing safe and effective NHPs.  Canadian consumers demand and deserve safe and high-quality NHPs.  CHFA supports this demand and encourages the entire supply chain, from raw material suppliers to NHP manufacturers, to use recognized quality standards that are well characterized and deemed fit for purpose.

 

Evidence

Evidence requirements for natural health products are proportional to the level of risk of the product. The referenced slide in The Fifth Estate episode referring to weak evidence is from a presentation given in 2012, prior to the implementation of the current risk-based system. Since then, Health Canada has published two guidance documents that outline evidence criteria for NHPs.  Under these documents, NHPs that are defined as medium- to high-risk require phase III or IV clinical studies or well-designed meta-analysis to demonstrate safety and efficacy.

On the other hand, low-risk NHPs that make general claims for minor, self-resolving health conditions or for general health maintenance claims have evidence requirements that reflect the low-risk nature of these products. Evidence such as traditional/botanical medicine textbooks or published peer-reviewed studies are acceptable as long as the entirety of evidence submitted supports the safety and efficacy of these low-risk products.

The guidance documents also provide predictable, consistent and clear instructions on what is required when filing a product licence application.  These new tools have drastically improved the quality of submissions as applicants now know with greater certainty what evidence is likely to be acceptable to Health Canada.

Vitamins and Minerals Products

In Canada, the commercial sale of NHPs is strictly regulated by the “Natural Health Products Regulations,” which requires products to be licensed by NNHPD before they can be sold. In order to be licensed, a product must demonstrate that it is safe, effective and high quality.

An important tool for product licensing is product monographs for common medicinal ingredients found in many NHPs. A product monograph is a factual scientific document on the specific medicinal ingredient that prescribes the safe and effective dose, as well as other parameters.

Using vitamin D as an example, the monograph outlines a maximum daily dose of 1,000 IU. If using a monograph to get a licence, NNHPD does not permit products providing more than 1,000 IU on a daily basis. As of today, there are no licensed products on the Canadian market with daily doses of vitamin D greater than 1,000 IU. Companies seeking a licence for a product containing more than 1,000 IU per day would be required to submit additional safety and efficacy evidence to support the dose.  NNHPD would thoroughly review the application and supporting documents to ensure it is, in fact, safe and effective.

CHFA recommends consulting a health care practitioner prior to making changing a health care regime.

Role of the Inspectorate

The slide in The Fifth Estate episode referring to the “Role of the Inspectorate” that discusses NHP complaints and quality is from a 2012 presentation. As of June 2014, there are 54,706 licences issued by NNHPD, representing 81,629 products on the market. There are approximately seven times more licensed NHPs on the market than licensed prescription and non-prescription drugs, combined. The statistic doesn’t surprise us when you take into consideration the sheer number of licensed NHPs on the market compared to other health products.

Another important point regarding the Fifth Estate episode is the fact that the Inspectorate receives complaints for numerous product-related issues. Complaints can range from low-risk complaints, to not tasting as desired, to concerns regarding public health. After the Inspectorate has verified the complaints for risks to health and safety, only the legitimate complaints are pursued by the Inspectorate. The Fifth Estate 2012 presentation statistic reflects all complaints submitted to the Inspectorate and not just the identified legitimate complaints.

Product Certifications

Product Certifications (Non-GMO Project Verified and Certified Organic)

There is an increase in consumers’ desire to know where their food comes from and if it has been genetically modified. Canadians consistently support labelling of foods containing Genetically Modified Organisms (GMOs), citing consumers’ right to know where food comes from and the impact its production has on the environment. While the debate surrounding GMO foods continues, suppliers are increasingly stepping up to the plate and offering certified organic products, which is an assurance that foods are produced without the use of GMOs. This trend will continue throughout 2015 in response to consumers’ demand to know what is in their food, and increased labelling activism in Canada.

The key certification to look for on foods is the “Canada Organic” logo; a clear indication that a product has been certified organic. In order to obtain an organic certification, products must go through a stringent review process and demonstrate that the ingredients used are sourced from certified organic sources and do not contain any GMOs. When buying organic foods, Canadians are investing in their health and supporting sustainable, environmentally friendly agricultural practices and animal welfare.

Another certification gaining ground is the “Non-GMO Project Verified” designation. This rigorous verification process is specific to the inclusion of GMO ingredients in products, carefully reviewing the source of each potentially genetically modified ingredient in a product.

As the trend toward general health and wellness increases across Canada, consumers are becoming more educated about new and innovative ways to optimize their health. This year, they can expect to see exciting innovations and new research showing the health benefits of unique health foods popping up in natural health food stores across the country.

Vitamin A

A; it’s the first letter of the alphabet and in the absolute logic of early scientists, it was one of the first vitamins ever discovered and isolated just over 100 years ago.

Even with a long history of understanding its necessity, approximately 40 per cent of Canadian adults do not meet their requirements for vitamin A from food. It is a fat-soluble vitamin essential for the function of the immune system, vision, reproductive health and cell communication.

Vitamin A is one of the most common deficiencies around the world, with disastrous consequences including blindness, a weakened immune system and death.

Pre-formed vitamin A is only found in animal sources like liver and fish, but the body can convert it from a plant pre-cursor called “beta-carotene”. Beta-carotene can be found in yellow and orange vegetables including yellow peppers and carrots, however it’s absorption and activity is much lower than pre-formed vitamin A.

This is why a supplement might be a good option, because they can provide the high quality, pre-formed vitamin A your body absorbs and uses best.

When considering a vitamin A supplement, it’s really important to speak with a health care practitioner to see if it is right for you. Particularly for pregnant and breast-feeding women, having the right levels of vitamin A (and not too much) is very important.

Speak with your health care practitioner about vitamin A.

 

Calcium

Calcium is not just about bones.

True; 99 per cent of the calcium in our body is stored in our bones, but it’s the other 1 per cent that is so important.

Many people don’t realize that it is essential for regulating blood pressure, nerve transmission, muscle contraction, blood clotting, ensuring a balanced body pH, and essential to thousands of enzyme and hormone reactions.

Yet calcium is the single most inadequately consumed mineral among Canadians of all ages. More than 80 per cent of Canadians over the age of 50, both male and female, reported inadequate intakes of calcium from food according to a Health Canada report.

It’s hard to get all the calcium we need from our diets. Dairy products are the go-to sources of calcium, but you would need to drink half a litre of milk each day to meet your body’s needs. For vegetarians or vegans, it would take over 3 litres of soy beverage or almost 20 cups of chopped broccoli to meet Health Canada’s recommended intake of 800 mg/day for most adults.

Calcium supplementation in older adults has been shown to reduce bone loss and fracture risk, which are crucial risk factors for osteoporosis.

For a more in-depth discussion of Calcium, please click here.

 

Dietary Fibre

It’s no surprise that Canadians continually come up short when striving to meet their fibre requirements from food.

A western diet full of processed and fast-foods means whole-foods are sadly lacking, and fibre intake falls far short of the recommended 25 grams/day for women and 30-38 grams/day for men.

And when the benefits of fibre include blood sugar regulation, weight maintenance, heart health, and gut health, it’s important to try to fill the gaps.

Fibre comes in two major forms: “soluble” and “insoluble” and both are necessary for optimal health.

Insoluble fibre, found in fruits, vegetables and whole grains, does not dissolve in water and adds bulk to keep things moving through your digestive tract, keeping you regular and speeding up the elimination of waste.

Soluble fibre, found in chia seeds, barley and black beans, can trap dietary cholesterol and fats and carry them through the intestines unabsorbed. It can make you feel fuller for longer, helping to maintain a healthy weight. It’s also great for feeding our healthy gut bacteria, which has many benefits.

If you find it difficult to increase these dietary sources, a number of supplements that provide various forms of soluble and insoluble fibre are available at your local natural health retailer. When using fibre supplements, remember to increase your intake slowly over a week or two to allow your body to get used to a higher fibre intake. Going too quickly can cause uncomfortable bloating and gas.

Speak with your health care practitioner about which fibre supplement might be right for you.

 

Vitamin D

There are two things that people usually think of when they hear “vitamin D”: first is summer sunshine and the second is strong bones. Sunshine because vitamin D can be made in the skin through exposure to UV light. Bones because it helps our bodies absorb calcium to build a strong skeleton. However, according to scientific research from the past few years, the role that vitamin D plays in our bodies goes far beyond bones.

Vitamin D is a hormone that is produced in the skin in response to direct sunlight exposure; particularly UV-B rays. In the winter months it is extremely important to use a vitamin D supplement because there is zero production in the skin; the UV-B rays needed to make Vitamin D do not reach Canada at that time of year because of the angle of the earth in relation to the sun. The combination of this factor and an indoor lifestyle has resulted in chronically low levels of vitamin D within the Canadian population. Some estimates suggest that 70 to 97 per cent of Canadians have insufficient levels of this essential nutrient.

Chronically low vitamin D levels in the population is thought to be one of the main culprits in the soaring rates of osteoporosis in Canada.

More research over the past few decades has given vitamin D other reasons to shine. It has been linked to reductions in some types of cancer, shown improvements to the immune system and has even shown benefits for improving and maintaining good mental health.

As such, a number of foods are Vitamin D fortified including milk, soy beverages and some orange juices. However, obtaining the recommended amount of Vitamin D from these sources would mean drinking two litres of fortified milk or soy beverage every day. There are few natural sources of vitamin D. Certain fish, like mackerel, provide some, or some mushrooms that have been exposed to sunlight. But the actual amount found in these sources varies dramatically, making it hard to be sure you are getting enough.

Supplementing with Vitamin D is almost universally recommended, particularly for those in greatest need, including infants and the elderly. There are many types of supplements available at different dosages and in different forms including tablets, capsules, or liquid drops.

Speak with your health care practitioner about which is right for you and visit your local natural health retailer for more information.

For a more in-depth discussion of Vitamin D, please click here.

 

Pin It on Pinterest