The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

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This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

Phase I – Target Spring 2021 will include amendments to the Natural Health Product (NHP) Regulations to improve labelling of NHPs.

Phase II – Target Spring 2022 will include amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs such as expedited pathways for lower-risk products.

Phase III – To introduce for consultation, regulatory amendments to address evidence standards for similar health claims, extending risk-based regulatory oversight, and additional powers for Health Canada to require a recall or label change for all self-care products.

There will be an opportunity to provide comments on Phase I of the Self-Care Framework during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2021 and last 70 days.

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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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.

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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

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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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