Health Canada released a DEL Bulletin, No.74 Disinfectants and Hand Sanitizers, on March 17th with clarifications that followed on March 20th containing details on licensing requirements for disinfectant and sanitization products. Health Canada also released a proactive action plan to increase domestic capacity of these in demand products. The interim regulations will allow disinfectant and sanitization products authorized or registered in the US, MRA or a PIC/S jurisdictions to be imported and sold in Canada to assist with the supply and demand. This will permit these products to be imported and sold in Canada in the interim, even though they do not meet the full Canadian labelling and licensing requirements.

Facilities that currently possess a Drug Establishment License (DEL) or Site License (SL) can begin importing new products once they notify Health Canada of the product, update their import license to include the foreign manufacturer(s)/packager(s)/labeler(s) of the product (which also can be expedited because of this current process), and must maintain the appropriate records on file. Health Canada has also encouraged pre-authorized facilities capable of retooling to begin producing sanitization products.

Health Canada is putting in their best efforts to minimalize the spread of COVID-19 and to assist Canadians with obtaining products to help prevent them from contracting the virus. The release of these new interim regulations to expedite the production and importation of disinfectant and sanitization products is a step towards achieving a future without the virus. Let’s hope the future is soon.

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

Emily Campbell

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Patent protection is often considered the Holy Grail of innovation. If you have a shiny new invention, it will benefit from long-term protection. A patent can allow you to build your business and hopefully sell it and make you very rich. But like most things, there are shades of grey.

Say you are able to get a patent. How strong is it? Can a smart person work around it? And even if your patent is rock solid, that does not stop copycats. A patent only allows you to sue them for infringement. That’s a huge misunderstanding for many new innovators. What if you launch and five copycats appear on the market? You need deep pockets and a talented legal team to deal with this. I have seen innovators abandon their patents because they didn’t have the funds or stamina for the litigation.

Going back to the entrepreneur with an old molecule. Many of the regulatory hurdles had been overcome by previous innovators. The few remaining ones seemed surmountable. I have seen projects like this become hugely successful with rapid scale up and sales execution. If copycats arrive, the entrepreneurs continued to innovate with product improvements, line extensions, and new sales and distribution channels.

Sure, a rock-solid patent is great to have but it’s not the only option to make you a successful innovator.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Patents” video, which continues this article in more depth. Watch it here.

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 .

Rob Fichtner, October, 2019

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When it comes to complaints, these are things I look at:

1. The seriousness of the complaints. In my world of regulated products, these usually pertain to adverse reactions, issues of health and safety etc.

2. The percent of complaints to units sold.

3. Trends. Are complaints going up, down, sideways?

In the case of my recent sleepless entrepreneur, none of the complaints was particularly serious. In terms of the absolute number, a dozen seemed like a catastrophe. But it turns out that there were over half a million units sold; the complaint rate was about 0.002%, miniscule. In terms of trends, it was a predictable steady growth of complaints as the business expanded. Time for a good night’s sleep!

The other advice I give to entrepreneurs is if you are not getting complaints or at least some type of feedback, I would be concerned. Unless you are an absolute genius, your product will launch with further optimization needed. All within reason of course. So I say, embrace your complaints. Master dealing with them. And use them as learning for your next generation innovation.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Complaints” video, which continues this article in more depth. Watch it here.

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 .

Rob Fichtner, October, 2019

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So, how does it work? The laser ultrasound machine consists of two lasers; one that emits a light wave and one which receives a soundwave. The conversion from light to sound waves occurs on the skin. The light wave causes the blood vessels in the skin to expand. The body then cools the blood vessels causing them to shrink. This rapidly repeats as continuous light wave approach. The repetition of this process results in vibrations along the skin. These vibrations make up a soundwave. The conversion from light to soundwave was critical for this cutting-edge medical device as soundwaves travel deeper into the body allowing for a more in-depth image of the desired area.

After the conversion, the soundwave travels into the body and is reflected at varying frequencies as skin, muscle, and bone tissue absorb different amounts of the produced soundwave. The reflected soundwave is then absorbed by the second laser. Finally, the information received by the second laser is translated into an image. This medical device is profound by converting the light wave to a soundwave in order to remain independent from the body.

Although ultrasound is already considered a non-invasive procedure, the ability to conduct one without any contact at all is beneficial to patients who cannot be touched. Such patients could be infants, burn victims, and patients trapped in an accident. The researchers at MIT hope to improve the depth and accuracy of this new medical device. The researchers also hope to decrease the size of the technology with the aspiration of making the laser ultrasound a household medical device for preventative and proactive medical care. With technology like this already being discovered this early in 2020, it is clear that the future is bright, inventive, and upon us now!

To see an explanation of the laser ultrasound directly from MIT, please click here. For another article on this topic, please click here.

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

Emily Campbell

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Physical Sunscreens vs. Chemical Sunscreens:

According to the American Academy of Dermatology and the American Academy of Dermatology Association, physical sunscreens work like a shield while chemical sunscreens work like a sponge. Physical sunscreens contain the active(s) zinc oxide and/or titanium dioxide, and work by sitting on the skin’s surface deflecting the sun’s rays. On the other hand, most chemical sunscreens contain one or more of the following active ingredients that absorb the sun’s rays: oxybenzone, avobenzone, octisalate, octocrylene, homosalate, octinoxate.

Originally, the chemical sunscreens were used in small quantities for preventing sunburn on vacation. According to a CNN article, the FDA started to become concerned about chemical safety when sun protection agencies started recommending daily application on large parts of the body.

Oxybenzone seems to be the most concerning active ingredient in sunscreens. In a small FDA study of sunscreen chemicals, oxybenzone was absorbed into the body at a concentration of approximately 50 to 100 times higher than the other three chemicals. Other studies have shown a potential link between oxybenzone and changing hormone levels in men, including lower testosterone. According to the article, it is also the most common cause of contact allergies and can also leach into breast milk.

Experts say that you should NOT stop using sunscreens. Further studies need to be conducted to determine the medical implications, if any, of sunscreen absorption. However, the increasing awareness surrounding the potentially harmful absorption of these chemicals encourages consumers to be more cautious about the type of sunscreens they purchase. Alternative sun protection methods include avoiding sun exposure at peak times, using protective clothing, and wearing a hat.

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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