To provide a brief background on the topic, Health Canada published a notice on a requirement for all MAHs of Canadian drug products classified as human pharmaceuticals, biologics and radiopharmaceuticals to evaluate and analyze their products for any presence of N-nitrosamine impurities. This was due to the concern that N-nitrosamine impurities have on human health as they are classified as probable carcinogens. Health Canada has requested that MAHs thoroughly review their products and manufacturing process for any potential sources of N-nitrosamine impurities (step 1: risk assessments – to be retained by the MAH) including reaching out to their API suppliers for an evaluation on their APIs, test their products for any potential presence of N-nitrosamine impurities (step 2: confirmatory testing), make any necessary changes to the product to ensure their products do not exceed the acceptable limit of nitrosamines (step 3: changes to the market authorization as a result of the previous steps), and then report the presence of nitrosamines within their products to Health Canada, if applicable.

For MAHs of drug products containing chemically synthesized APIs, please note the following due dates for the risk evaluation steps:

1. Risk Assessments: Due March 31, 2021
2. Confirmatory Testing (If a risk is identified): Due October 1, 2022
3. Changes to the market authorization: Due October 1, 2022

For MAHs of biological or radiopharmaceutical products, please note the following due dates for risk evaluation steps:

1. Risk Assessments: Due November 30, 2021
2. Confirmatory Testing (If a risk is identified): Due November 30, 2023
3. Changes to the market authorization: Due November 30, 2023

Our most recent article on this matter can be found 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.

The post Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching appeared first on Focal Point.

The agreement was made to reinforce the economic ties between the United States, Mexico, and Canada while replacing the North American Trade Agreement. The agreement promoted efficient and transparent customs procedures that reduce costs for both importers and exporters. The agreement includes regulations with elements of environmental protection and a gender bias analysis, which ensures equal opportunity for all gender, race, and for small and medium enterprises.  

We have previously reported on which products will be impacted by USMCA, however this list has since been amended. Previously, the impacted Natural Health Products and Non-Prescription Drugs were only those on Health Canada monographs. This has since been changed to include all products listed within the appendix of the USMCA, such as antiseptic skin cleansers, acne therapy products, and antiperspirants. This requires changes to List A: List of Certain Natural Health Products for Distribution as Samples, List D: List of Certain Non-prescription Drugs for Distribution as Samples, List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019, and of the Food and Drug Regulations Do Not Apply, to include all currently authorized products in the USMCA.  

This revision could not be made officially prior to the July 1^st implementation date. For now, the products listed in the appendix of the USMCA will be exempt from sampling prohibitions and the enforcement actions will be de-prioritized. After a comment period, a Notice of Modification as well as the revised lists will be published on Health Canada’s website.  

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. 

The post Implementation and Updates to the USMCA appeared first on Focal Point.

Products impacted by this (Annex A of the bulletin) will no longer require identity testing after receipt in Canada and will also not be required to undergo confirmatory testing in the interim during this pandemic. Importers, however, will still be responsible for ensuring products meet their required specifications and were manufactured under Good Manufacturing Practices. This will give importers of products impacted by this the opportunity to directly ship from fabricators to retailers, as long as the importers release the product before being shipped via review of the necessary documentation and test results as well as ensuring quality agreements are put in place between the foreign manufacturer, importer, and receiver of product.

It should be noted that this update to current low risk non-prescription drug import regulations does not exempt the responsibility of Canadian Quality Control department to ensure all products comply with Canadian regulations. These updates simply minimize any delays that may occur in the process of importing non-prescription drugs during these troubling times.

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

The post Less Testing for Imported Low-Risk OTC Drugs – Temporarily appeared first on Focal Point.

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.

The post Can Sunscreen Absorption into the Bloodstream Pose Health Risks? appeared first on Focal Point.

According to Medical Design & Outsourcing, the FDA has warned the public of a potential medical device shortage as a result of the plant shutdown. Roughly 90% of the products sterilized at the Sterigenics Willowbrook facility were medical devices and manufacturers of those products will be greatly impacted by this plant shutdown.

Health Canada has issued a clarification notice on what sort of changes to sterilization procedures would require Medical Device Licence (MDL) amendments. According to Emergo, Health Canada has advised that facility changes alone do not warrant a new MDL application submission. However, MDL amendments are required for changes to sterilization procedures, equipment or cycle parameters. MDL amendments are also required for the following:

• Changes that increase bioburden alerts or action levels;
• Changes that introduce organisms more resistant to sterilization effects;
• Device design and material changes that introduce features more difficult to sterilize;
• Changes in density or configuration of a sterilization load;
• Changes to quality control verification and validation processes.

As a result, moving the sterilization facility may result in one or more of the above changes, therefore leading to potential MDL amendments for several medical devices.

If you require assistance complying with medical device regulatory requirements or would like more information on the matter, 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.

The post Effects of Sterigenics Plant Shutdown on Medical Device Licences (MDL) in Canada appeared first on Focal Point.

According to Cosmetics Design USA, vice president of global digital services at Amway, Mike Edwards, states: “If you look at companies like Uber, they didn’t do anything unique. It’s still the taxi industry. But they leveraged digital tools to make that a very compelling opportunity. It’s the same thing if you look at direct selling and you look at Amway. If we don’t disrupt the industry by leveraging digital tools, we’ll become irrelevant.”

The overarching purpose of the app developments is to help Amway Business Owners (ABO) serve their customers better and drive mobile sales, while strengthening the relationship between the ABO and customer through digital technology. By storing components of the app on a global cloud storage space, standardization becomes easier to achieve between apps, and allows for brand consistency among markets in different countries.

Brian Hart, vice president of ABI customer solutions and IT at Amway, declares that the app development plan will save a substantial amount of money while allowing the company to gain international brand awareness and further improve customer experience. “Everyone has a mobile phone, but not everyone has a computer,” observes Hart. By leveraging this common device, Amway reduces the possibility of an external competitor disrupting their business with app development solutions in the future.

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.

The post Amway Launches 50 New Apps with New Digital Technology Model appeared first on Focal Point.

Health Canada published an updated timeline for the various phases in the framework’s implementation process.  Due to the upcoming Canadian Federal Election, there have been changes to the original schedule. After public consultations, the updated approach to regulating self-care products is targeted to be phased in over the next few years:

Phase I (Spring 2020) – Health Canada will introduce labelling amendments to Natural Health Products (NHPs). The changes will include improving the facts table for easier comparison between similar self-care products, as well as plain language on labels for consumers to easily understand.

Phase II (Spring 2020) – Health Canada will introduce a risk-based approach to regulating non-prescription drugs under the Food and Drug Regulations (FDR). The approach will include expedited pathways for lower-risk products such as sunscreens and acne products to align with regulations for self-care products with similar risk level.

Phase III (2021) – Health Canada will introduce regulatory amendments to address health claim evidence standards and extend regulatory oversight with a risk-based approach. Phase III will also seek additional controls for Health Canada such as having the ability to require recall or label change for all self-care products.

These changes to the regulatory framework are anticipated to support the safe and intended use of self-care products to help Canadians make more informed decisions when buying products. It is also intended to establish proportional regulatory rules based on risk, which would result in significant cost reduction for health care businesses..

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.

The post New Self-Care Framework Timeline appeared first on Focal Point.

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.

The post Health Canada takes Action on Talc appeared first on Focal Point.

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.

The post An Unsung Hero: Could Blue Light be the Answer to Hypertension? appeared first on Focal Point.

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.

The post Cosmetovigilance: Safety in Cosmetics appeared first on Focal Point.