If Health Canada determines that a medical device authorized for sale in Canada does not meet safety and effectiveness requirements, manufacturers of a Class I device, and the medical device licence holders of Class II to IV medical devices are requested to prepare and submit an issue-related analysis. Device complaints and incident reports, clinical data and other evidence, exposure data or sales data, device malfunction trends, quality issues, labelling and conclusion must be included in the assessment reports. The default timeframe for submitting an analysis is 30 calendar days from the date of the request unless specified otherwise by the Minister.

If you need any help drafting these reports, contact us and we’ll happily assist you.

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Omron Healthcare Inc. has recently disclosed a new feature that allows Amazon Alexa devices to take blood pressure readings, as well as compare them to other readings taken over time. Amazon Alexa users can ask simple questions about their blood pressure, and receive information about their cardiovascular health from the comfort of their own home.

How can it be used?

The new technology can be accessed through the Omron Connect app used in conjunction with the Alexa app, both of which can be downloaded for free from Apple iOS or the Google Play store. They can sync with Omron’s blood pressure monitors, and provide information on average readings, or judge the readings against the last highest/lowest recorded readings, and much more. It also allows Alexa to provide guidelines for measurement to ensure the readings are taken accurately, making the monitoring of blood pressure easy for patients new to the practice.

For those without adverse health conditions, regularly monitoring blood-pressure with Alexa can provide insight on cardiovascular health conditions for proactively taking health into one’s own hands. It can help one act sooner on obscure numbers and can potentially be life-saving.

Omron Healthcare European president and CEO André Van Gils said: “It’s more important than ever for us to find new ways to help people simplify and ease their blood pressure monitoring habits, so that they can understand and manage their condition more efficiently.”

This new cardiovascular health monitoring addition to Amazon Alexa has consumers wondering what Amazon will come up with next.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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A risk assessment is an integral part of maintaining both the health of Canadians and the environment. Risk assessments are executed by Environment and Climate Change Canada under the CEPA (Canadian Environmental Protection Act) and are used to “determine whether there are risks resulting from exposure of Canadians to the substance or releases of the substance into the environment, and the specific ways Canadians or the environment can be affected”. The assessment of chemicals allows for proper regulatory measures to be taken.

What risks does talc pose to human health?

The assessment mainly focuses on the risks talc poses within self-care products and concludes that it be classified as CEPA toxic. This conclusion is due to two associated risks with loose powder forms of talc. One of the two risks discussed is the inhalation of talc from loose powder products. This risk encompasses products such as baby powder and industrial applications in which talc is airborne. Warning labels have already been required on products like baby powder that are marketed for the use on infants, cautioning to avoid inhalation of the product by the infant. Inhalation of talc can lead to respiratory problems including “coughing, difficulty breathing, decreased lung function and scarring of the lung tissue”. Perhaps more serious of the risks is the possible associations with ovarian cancer. When used on the perineal region in women it was found that it is possible for talc to migrate and find itself lodged in the reproductive system. This judgement comes off the heels of the July verdict of the class action lawsuit of Johnson & Johnson by 22 women who claimed consistent use of J&J Baby Powder on the perineal area had led to their ovarian cancer (due to alleged contamination of talcum powder with asbestos). Johnson & Johnson was found guilty, with the court ruling in favour of those affected. Several studies have also been conducted to observe the possible risks associated with talc, these are included in the documentation provided by CEPA. It is important to note that, in pressed form or consumables (ie. Some cosmetics or foods or drugs), Health Canada did not find talc harmful.

Where does this leave Talc?

The findings show talc as a health threat, but that it presents no threat to the environment. In terms of talc as an ingredient in self-care products; those that are non-airborne, don’t come in contact with the perineal area or are consumed are deemed safe. However, in the meantime, consumers are left to make the decision themselves if they would like to stay away from talc-based products.

Despite these published documents, nothing is set in stone until the final assessment.  A 60-day comment period has opened allowing for comments to be made upon the presented information and conclusions. If passed, the proposed conclusions published by Health Canada would result in the following outcomes as means of risk management:

• Possible modifications to the Cosmetic Ingredients Hotlist to prohibit or restrict talc and its use in cosmetics and perennial products
• Possible modifications to the Natural Health Products Database and associated monographs to reduce the exposure of talc to consumers in NHPs and OTC drugs that have risks of being inhaled or usage associated with the perineal area

Important Dates to Note

• The draft screening assessment was posted online by Health Canada on December 5^th, 2018
• A 60-day comment period has opened and will close on February 6^th, 2019

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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The study was performed by the University of Surrey and involved the irradiation of subjects with whole-body blue light at 450nm, roughly comparable to that of a dose of sunlight. Unlike its cousin ultraviolet (UV) light, blue light is non-carcinogenic and does not share the potential cancer-causing concerns. The results of the study showcased a significant decrease in systolic blood pressure comparable to the effects seen with medication targeted to have similar effects for those with hypertension.

A surprise to the unassuming consumer, blue light’s reputation may see a shift from positive to negative as more and more studies are aimed at finding natural treatments to common physical ailments and shortcomings. A potential solution to those who are difficult to treat with oral pill form solutions for hypertension, this study showcases a potential solution to a common disorder that affects hundreds of thousands of people each year.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Cosmetovigilance can be described as the careful post-market surveillance of cosmetic products after they have been made available to consumers.  More simply put it can be defined as monitoring cosmetic safety.  Similarly to the concept of pharmacovigilance associated with drugs, cosmetovigilance employs the principles of post-market monitoring to keep record of adverse reactions to products. Monitoring these unintentional and un-desirable effects is a key aspect of successful marketing of these products.

What is the importance of cosmetovigilance?

Cosmetovigilance is especially important because the safety and clinical trial testing of cosmetic products are under less scrutiny by regulators than other products such as drugs, natural health products and medical devices.  This makes monitoring and reporting observed adverse effects important. There are no forms of pre-market approvals for cosmetic products in the United States or Canada (with the exception of batch certification of certain colour additives in the US), allowing these products to be easily introduced to market. The effectiveness and safety of cosmetics are entirely left to the discretion of the manufacturer, which may include testing, but it is not a requirement. As such, proper incident reporting post-market is of the highest importance. With a proper system in place problems can be identified early and changes made, limiting the size of the population affected.

Where does the responsibility to uphold/enforce cosmetovigilance fall?

The responsibility to ensure that a safe product is being marketed falls upon the manufacturer. They should be aware of risks, if any, associated with their product before releasing it into market place and if needed make consumers aware of these risks.  When it comes to the reporting of adverse effects from the use of a product the responsibility falls both on the manufacturer and the consumer. Throughout the years, cosmetovigilance has proven to be a vital tool for protecting consumers from negative side effects of products.  A common product in Asian countries, skin lightening creams have had an increase in popularity in recent years.  Lighter complexions are seen as true beauty in these regions, leaving consumers willing to do anything to achieve the ideal complexion.  Risky but effective, there are many different products on the market capable of being used to help accomplish this, from creams and gels all the way to injections (considered as illegal drugs). However, some of the raw materials contained in these products can be dangerous and have permanent damage to internal systems. One concerning additive in question in these formulations is mercury. Mercury is banned from cosmetics in nations such as the European Union and other nations such as the US and Canada have strongly enforced concentration limitations.  Despite wide scale bans, mercury is still popping up in formulations and these dangerous products are being smuggled into countries or sold online. The use of these mercury-containing products also does not solely affect the individual using it. Traces of this dangerous substance can easily be passed to unsuspecting bystanders that encounter that individual and even into water supply. In 2016 the FDA stressed the importance that these products stop being used. Without proper post market evaluation, investigation and regulation its possible that many of these products would be remain easily accessible to consumers, contaminating their homes and more importantly their bodies.

What effects can proper cosmetovigilance have on industry?

Keeping track of adverse effects from cosmetics is what can often lead to certain ingredients being restricted or prohibited by regulators. Manufacturers may even choose to pull a product from shelves if an increasingly high number of complaints is received. If consumers are seen to experience sensitising effects from certain ingredients the rules surrounding that ingredient may be amended. In short, without proper cosmetovigilance, vital changes to both product availability and regulation would be less frequent.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Pharmacovigilance is defined by the World Health Organization as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. In simpler terms, pharmacovigilance can be defined modestly in two words, drug safety. The study of drugs and their associated risks and effects does not simply end after lengthy studies and clinical trials.  Long after their development phase it is important that their ongoing effects and interactions with consumers continue to be monitored.

What is the importance of Pharmacovigilance and what are its effects?

A necessary step for not only prescription drugs but those less heavily regulated like OTC drugs, pharmacovigilance helps to monitor the safety of these products after consumer consumption. Recently, it has been seen that the FDA is choosing to crackdown on the safety of certain medications.  It was reported by USA Today that the FDA had begun an intensive investigation into certain blood pressure medicines with suspicions of contamination by cancer-causing impurities. These further investigations are essential to ensure the safety of consumers. With recall of medications that exhibit serious side effects or signs of contamination, the health and safety of consumers can be protected.

What is the Importance of Adverse Reaction Reporting to Pharmacovigilance?

A key aspect of pharmacovigilance is adverse drug reaction reporting. A strong determining factor in the longevity of products in market place, the reporting of these reactions is pertinent to maintaining consumer health. Without adverse reaction reporting, products that are otherwise unsafe for consumers may slip through the cracks and be left accessible to more consumers. No truer example of its importance, the 1960s thalidomide disaster that resulted in severe birth defects is a prime example of the importance of pharmacovigilance. Originally prescribed to treat morning sickness in pregnant women, this drug was seemingly harmless. Without a proper recall of this dangerous drug more and more unsuspecting expecting mothers, would have been susceptible to traumatic effects of this drug. In fact, it was this disaster that further spurred Health Canada to more tightly regulate and monitor prescription drugs and their release into marketplace. Proper regulation before and after market of drug products can ensure that disasters like this one do not occur.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Statements to the Effect of…

“Statements to the effect of” has been proposed to be eliminated with the new electronic form submission. The revised monograph could veer off the current path in that instead there will be a list of all acceptable phrases instead of using “statements to the effect of”. There will be a reduction in variability with hopefully less room for mistakes in claims on products.

Doses and Permitted Combinations

The proposed revised monograph features a defined subpopulation. Previously, there was an absence of a subpopulation. In the newly revised monograph, it features the potential for the subpopulation to be defined as strictly “adolescents over 12 years of age and adults”.

Specifications

The new proposed monograph will feature optional Drug Facts Table examples for both drug and NHP (Product Facts Tables) for acne therapy products.

Non-medicinal Ingredients

Equally important in any formulation, non-medicinal ingredients are often ignored in drug and natural health products as there is typically emphasis on the product’s actives instead. Alternatively, to using INCI nomenclature for non-medicinal ingredients, the new proposed monograph states that the non-medicinal ingredients must be present on the current Natural Health Products Ingredients Database (NHPID). The ingredients must also meet the criteria outlined on the database and/or other ingredient databases, such as the Food and Drug Regulations or Canadian Cosmetic Hotlist.

Additional Changes in Language

Directions for use is typically the first section a consumer is drawn to on primary packaging. With the new monograph, there may be wording changes in the Directions for Use for both leave-on and rinse off products. The wording for “Caution/Warning” statements may also be modified. Additionally, products with benzoyl peroxide will most likely require the presence of additional warning statements related to sun exposure and proper sun protection.

The consultation period for the Anti-Dandruff, Medicated Skin Care, and Acne Therapy has recently passed, therefore we now await the final decision on what will officially be present on the newly revised final version of these monographs. According to Health Canada, the next ones on the agenda to be placed under consultation after review are Oral Health, Lozenges, and the Sunscreen Monograph. Stay tuned for more information on those proposed changes.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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In a surprising move made by Health Canada, CBD has been added to the prescription drug list rather than being classified as an NHP (natural health product). CBD has long been associated as treatment for a variety of ailments and a quick internet search for the benefits and use returns treatment for ailments such as depression, anxiety and even seizures. An NHP is not allowed to make claims to treat more serious diseases and conditions like these. It’s for these reasons that CBD was left at the platform while recreational cannabis has left legalization station. NHPs are considered as a form of self-care without the requirement of intervention by a medical practitioner. However, the diseases that CBD aims to treat are much more serious and usually require the supervision by a medical specialist. Additionally, with a product receiving an NHP classification, Canadians would not require a prescription in order to purchase such products, leading to a higher associated risk if highly concentrated products are not used effectively or correctly.

While many Canadians jumped for joy and painted the town green with the recent legalization of recreational cannabis, a minority remain disappointed. Health Canada has chosen to regulate CBD more aggressively than expected. Many Canadians feel as though it should have been legalized along side cannabis especially because it is often considered as the lesser of two evils.  Risk aside, CBD has been shown in a variety of studies to have therapeutic benefits. One non-profit “Get Well Not High” is even taking the time to encourage Canadians to lobby to their MPs to encourage a change in legislation to allow CBD products to be more easily accessible. As time goes on there’s no telling what changes will need to be made to existing legislation to compliment the ever-changing environment of legalization.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Like it or not, its clear that consumers are being more and more careful when selecting products they wish to purchase.  It comes as no surprise that the FDA has begun to recognize this changing landscape. As of November 7^th, the FDA announced its proposal to introduce a web-based cosmetic allergen survey. A further recognition of ever-changing consumer landscapes, this survey gives the opportunity for data regarding sensitivity to be collected from consumers. The FDA states the purpose of the survey to “better understand consumer perceptions and awareness regarding allergens in cosmetics as well as consumer decisions about whether to purchase specific products or to avoid certain ingredients”. The FDA hopes to gather new and valuable insight into the world of cosmetic allergens. If conducted this survey will be the first on consumer perceptions of cosmetics since 1975. Long overdue, this proposed data collection comes at a time as good as ever for the FDA to gather information concerning consumer knowledge and perception.

Not yet at the green light, the FDA still requires approval from the Office of Management and Budget (OMB) before the allergen survey can commence. A first step towards approval, the survey has entered a consultation period for 60 days in which comments upon the survey will be collected. A recognition of changing consumer climate, it comes as no surprise that agencies like the FDA are looking to pick the brains of consumers to have a better grasp on the collective ideologies present in marketplace.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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With growing global leniency on this once highly regulated and stigmatized substance, a change in perspective is having a profound effect on its use in cosmetics and other forms of personal care. Big companies like Estee Lauder are starting to cash in on cannabis ingredient trends. As part of their brand Origins, they will be releasing a calming face mask with the inclusion of cannabis sativa seed oil. The first Estee Lauder Company owned product to be released with cannabis-based ingredients, it comes as no surprise that in a time of social change that brands will capitalize on the beneficial aspects of this once controversial ingredient. More than smoke and mirrors, cannabis derivatives like CBD have been shown to provide valuable benefits for skin care.

2. Use of Nutraceuticals and Nutricosmetics

Now more than ever, health is becoming an ever-growing concern. Nutricosmetics, a definition not recognized by the FDA or Health Canada includes natural products with the goal of the promotion of healthy hair and skin. The concept of beauty from within is an ever-growing phenomenon. Far from a new concept, trends in supplements to aid in one’s outer beauty is growing. Popular brands like Centrum are releasing beauty supplements aimed at promoting the beauty of the skin, hair and nails. A staple in the beauty community and promoted by so-called Instagram influencers and celebrities at every turn, Sugar Bear Hair vitamins go hand in hand with anyone successful on Instagram. The company has come under media scrutiny on several occasions relative to their effectiveness. A seemingly easy fix for ones inner and outer beauty, these colourful sugary teddy bears have the masses flocking to them like seagulls on a single French fry in a parking lot.  Perhaps some of the charm of these in-demand style vitamin enriched supplements is their alluring colours and endorsements. Whether it’s a trend that’s here to stay or passing fad, its undeniable that consumers are driven to pursue all things natural for the betterment of their health.

3. Free-From Cosmetics Trends

“Free-from” products continue to grow to popularity with time as more and more ingredients are brought into the light of media scrutiny. Ingredients whether harmful or not are being targeted as potential irritants or other “scare tactic” concerns. Equated with old wives tales like the boogeyman and the sand man, many of these claims are nothing more than folklore that has been passed along by companies to give them an edge over their competitors. Validity to these claims aside, when consumers see ingredients like sulphates, parabens and other maligned ingredients they are quick to toss the product aside in favour of an alternative. Long gone are the days of using cost effective and well performing parabens. Parabens and other bad-mouthed preservatives are being replaced by alternatives such as organic acids combined with formaldehyde releasers.  Some people even go as far as to offer products with ‘no preservatives’ and tout this as a superiority claim. However, not only can products with no true preservative have reduced shelf life, they can pose a greater risk of contamination and thus a greater risk of consumer harm.  Many suggested ‘natural’ alternatives such as various essential oils and extracts must be used at incredibly high concentrations causing a severe trade off between making a product that’s effective and natural versus once that’s preserved.  Moreover, at high quantities these natural alternatives have the potential to cause high degrees of sensitization. Despite the downsides of some “free-from” options, “free-from” remains a popular claim that’s used to market some products as better than others. A poor man’s excuse for a benefit, “free-from” trends are often nothing more than marketing jargon that hurts the industry and potentially the consumer.

4. Blue-light Cosmetics Trends

With more and more time spent in front of a screen, it’s almost impossible to not think of the possible implications of this behavior.  Blue-light, a member of the visible spectrum, is emitted naturally as a member of white light from the sun but also artificially sourced from LED bulbs as well as the screen of electronic devices; we are increasingly becoming affected by this invisible tyrant.  Studies have shown that concentrated blue-violet light exposure can impart some damage to the skin due to oxidative stress.  To combat the damage from blue light, more and more companies are releasing various types of ingredients aimed at protecting the technologically-saavy beauty consumer. These innovative products employ similar principles to that of sun-protectants but with the bonus benefit of protection from harmful blue light.  Additionally, a variety of raw material companies are introducing new forms of ingredients such as antioxidants, aimed at reducing the oxidative stress imposed by blue-light on the skin. Media gimmick or serious concern, little is known in the ways of the seriousness of this threat.

5. Halal Beauty Trends

In a time where natural product trends seem to take hold of consumers, it comes as no surprise that consumers are in search of natural and “healthier” ingredients. A prime target for those of Muslim faith, halal-certified ingredients also boast a remarkably high ethical standard and reputation.  It’s this reputation that results in these products getting the attention of non-Muslim consumers. A close sister to vegan cosmetics, both do not include any animal products as part of their composition. The difference lies in the alcohol content, vegan cosmetics may still contain alcohol whereas halal does not.  Alcohol (with the capability of causing intoxication) is considered unacceptable under the Muslim religion, resulting in alcohols like ethyl alcohol being undesirable while non-intoxicating alcohols like cetearyl alcohol remain acceptable.

Undeniably, changes in the regulatory landscape as well as ongoing updates to trends are having a heavy impact on the industry.  Whether it be the growing desire for cosmetics free of certain stigmatized ingredients or products aimed at trending topics such as the consequences posed by the exposure to blue light-emitting devices, now is a time of innovation and progress. As technology advances so do the demands of consumers and this is seen to have a dramatic effect on what companies and brands push into the marketplace.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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