The update aims to reduce duplicate reporting and regulatory burden. Under the revised guidance, MAHs are not required to routinely monitor the Canada Vigilance Online database or Health Product InfoWatch for Individual Case Safety Report (ICSR) obligations. However, MAHs must still report serious, unexpected adverse reactions occurring outside Canada, including those identified through foreign regulatory authority databases. If it cannot be confirmed whether the product belongs to the MAH, the report should be submitted to Health Canada with that limitation noted.

The updated guidance took effect on February 19, 2026. If you have questions or would like guidance on how this change may impact your processes, please reach out to our team.

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Key Provisions of the Bill

The Core Ban: The bill prohibits animal testing specifically for cosmetics.

Effective Date: The proposed ban is set to take effect on December 31, 2026, giving the industry a transition period to adapt to new compliance standards.

Important Exceptions: To accommodate global trade requirements and multi-use chemical regulations, SB 1005 outlines specific exceptions where animal testing would still be permitted:

• Foreign Mandates: Testing that is specifically mandated by foreign regulatory authorities remains an exception.
• Non-Cosmetic Ingredients: Testing performed on ingredients that are intended for use in non-cosmetic products is excluded from the ban.

What This Means for the Industry This move by Arizona mirrors a growing trend across the country as more states move toward cruelty-free legislative frameworks. Brands selling in Arizona should begin reviewing their supply chains and testing protocols in anticipation of the 2026 deadline. 

The post Arizona Introduces SB 1005 to Ban Cosmetic Animal Testing appeared first on Focal Point.

If you require any assistance, require formulation reviews, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

Retinal (CAS No. 116-31-4 – Retinaldehyde) – added as a restricted ingredient.

a) Permitted in leave-on products intended for full body application at a maximum concentration of 0.01%.

b) Permitted in other cosmetics at a maximum concentration of 0.05%.

Thioglycolic acid esters (CAS No. 30618-84-9; CAS No. 25103-09-7 – Glyceryl thioglycolate; Isoocytl thioglycolate)  – added as a prohibited ingredient.

Mixed cresols and derivatives – entry revised to reflect:

Prohibition of p-Cresol and mixtures thereof – CAS No. 106-44-5; 1319-77-3 – Mixed cresols

m-Cresol (CAS 95-48-7; 108-39-4) restricted as follows:

a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose.

b) Restricted in other cosmetics at a maximum of 0.1%, and product label must bear the warning “Do not use in the area of the eye, mouth or nose”.

o-Cresol (CAS 95-48-7;108-39-4) restricted as follows:

a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose.

b) Restricted in other cosmetics at a maximum of 0.1%, and product label must bear the warning “Do not use in the area of the eye, mouth or nose”.

Peroxide and peroxide-generating compounds (CAS No. – 124-43-6; 1305-79-9; 7722-84-1; 1335-26-8; 7632-04-4; 1314-22-3 – Urea peroxide / Urea (carbamide) peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc peroxide) – entry revised to:

• Introduce a maximum permitted concentration of 10% (as applied) for hair products.

• Introduce conditions for eyelash and eyebrow products, which include a maximum permitted concentration of 10%, that such products must be sold for professional use only and the requirement for the statements “For professional use only” and “Avoid contact with eyes and, in the event of contact with eyes, rinse immediately with plenty of water and seek medical attention” to be listed on labels.

• Indicate that these ingredients are not permitted for use in products intended for application to the genital area.

Conditions of use for oral products were not changed from the previous version.

Benzoyl peroxide (CAS No. 94-36-0) – entry revised to indicate that the ingredient may only be used in nail products for professional use, along with a requirement for the statements “For professional use only”, “Avoid skin contact” and “Read directions carefully before using” to be included on labels.

Retinol and its esters (CAS No. 68-26-8; 127-47-9; 79-81-2;631-89-0; 7069-42-3 – Vitamin A; Retinyl acetate; Retinyl palmitate; Retinyl linoleate; Retinyl propionate) – entry revised to reflect a reduced maximum concentration in leave-on products intended for full body application to 0.2% total retinol equivalents. Other cosmetics continue to be restricted to a maximum restricted concentration of 1% retinol equivalents. 

The post Canadian Cosmetic Hotlist Updates appeared first on Focal Point.

New Requirements for Cosmetics:

1. Adverse Event Record keeping and Serious Adverse Event Reporting:

• Must report to FDA no more than 15 business days of event awareness
• Must maintain all related records
• Cosmetic product labels must list contact information for consumers to report side effects

2. Mandatory Facility Registration and Product and Ingredient Listing:

• Facility Registration by December 29, 2023 – All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA
• Must be renewed every 2 years
• Product Listing must be submitted within 120 days of market launch and it must be renewed annually

3. Cosmetic Safety Substantiation

• Adequate substantiation of safety is required for all cosmetics

4. Cosmetic Labeling and Fragrance Allergen Transparency

• Product labels must be updated to include fragrance allergens
• June 29, 2024 – List of allergens to be declared will be proposed by FDA and finalized within 180 days of the comment period ending
• Labeling must be updated by December 29, 2025

5. Current Good Manufacturing Practices:

• Manufacturers must meet GMP by 2025
• FDA is expected to publish a proposed regulation before December 29, 2024 and finalize it by December 29, 2025

6. Talc rule:

• FDA to publish a proposed test protocol for asbestos in Talc by December 29, 2023
• To be finalized 180 days after comment period ends

7. PFAS Report:

• FDA to assess the use of per- and polyfluoralkyl substances (“PFAS”) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics products
• FDA will publish the results of this assessment in a public report no later than December 29, 2025

8. Animal testing

• No requirements specific to testing involving animals, but animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances

MoCRA EXEMPTIONS:

• Small business exemptions apply – average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 AND
• Do not engage in the manufacturing or processing of the cosmetic products listed below:
  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
  • Cosmetic products that are injected.
  • Cosmetic products that are intended for internal use.
  • Cosmetic products that are intended to alter appearance for more than 24 hours.

If you have any questions or would like further information, please contact us.

The post <strong><u>The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”)</u></strong> appeared first on Focal Point.

The investigators conducted a randomized, double-blind placebo-controlled phase II clinical trial at nine sites in the UK. The trial was done with 98 patients who were hospitalized with Covid-19. In the treatment group, Interferon Beta 1a was inhaled from a nebulizer for 14 days, versus placebo in the control group.

Patients in the treatment group were twice as likely to recover clinically at day 15 or 16: 21 of 48 (44%) versus 11 of 50 (22%) in the control group. Eleven of the 50 patients in the control group became severely ill or died compared to 6 of 48 in the treatment group. None of the patients in the treatment group died. However, the odds of hospital release at day 28 was not significantly different between the two groups.

Interferons are proteins that are created in response to viral infections. Interferon beta is a protein that coordinates the immune response to viral infections such as COVID-19, however the coronavirus suppresses its release. It is also known that some severe Covid-19 patients have antibodies against another important Interferon, Interferon Alpha. The theory behind the inhalation of Interferon Beta is to simply replace the lung’s supply of interferons by inhaling it directly into the lung.

This study clearly showed great promise, but further work is needed to confirm both the safety and effectiveness of Interferon Beta 1a.

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 Interferon Beta 1a: Potentially Promising Treatment for Covid-19 appeared first on Focal Point.

The REP information will be sent to the HPFB via the Common Electronic Submissions Gateway (CESG) – similar to FDA drug submissions. XML format will be used and is ideal for Health Canada as it will minimize errors and therefore will improve consistency and reliability of the information captured. This new approach also eliminates the need for media such as CDs and DVDs. The template for the REP will aid in easier and faster data entry with drop down lists and predictive text.

Through the REP template, HPFB will collect routing IDs that will be used for two-way secure communication which will allow for quicker communication. The steps to beginning this process can be found here. As well, information on obtaining a dossier ID or obtaining a dossier from non-eCTD to eCTD is available here. It should be noted that the dossier is considered the REP dossier upon receipt of first transaction including a REP Regulatory Transaction XML file, afterwards the REP dossier must be provided using the REP company template. Health Canada recommends the familiarization of the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use and beginning the process of registering and setting up a CESG account and obtaining a dossier identifier as soon as possible, as this may take some time.

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 Health Canada: Mandatory Use of New Regulatory Enrolment Process for Drug Submissions appeared first on Focal Point.

The impact was first seen in China due to the lockdown in Wuhan, preventing citizens from leaving their homes. A large part of the cosmetic market is in China, but due to the lockdown, sales of cosmetic products have declined. Also, as many cosmetic companies rely on Chinese suppliers for their cosmetic materials, a delay or decrease in production has been seen by many. Finally, the medical device industry has seen a decrease in revenue due to fewer non-emergent procedures in China. This drop in elected procedures has caused lower than expect revenues for medical device companies in China.

Most recently, there have been many cancellations of public events, such as conferences and tradeshows, to prevent further spreading of coronavirus. This has involved the first cancellation of the Healthcare Information and Management Systems Society in 58 years, which was to take place in Orlando, Florida. This event was expected to have many health care professionals in attendance, and therefore the risk was too extreme to rightfully have the event. Another cancelled event was South by Southwest, a music, film and technology festival which was to take place in Austin, Texas and has been known for featuring the latest medical devices. Both events are currently exploring the possibility of hosting a virtual event to make it up to the disappointed attendees.

Other events have been more hopeful and have postponed to a later date. For example, in-cosmetics Global, an event for personal care ingredients, was to take place in Barcelona, Spain at the end of March, but has now been postponed to the end of June. However, there has been no prediction or expectation for the coronavirus to subside. Therefore, it is difficult to say if postponing, cancelling, or taking an event virtual is the best way to handle this unforeseen circumstance. One thing we can be sure about, this impact on the cosmetic and medical device industries will continue until coronavirus becomes less prominent.

For more information on the cancellation/postponement of the mentioned events, please visit South by Southwest, in-cosmetics Global, and Healthcare Information and Management Systems Society. For the most recent information on COVID-19 please visit the WHO.

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 COVID-19 Impact on Cosmetic and Medical Device Industry appeared first on Focal Point.

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

The post Patents: Misconceptions and Watch-Outs”. appeared first on Focal Point.

Once knowledge of coronavirus becomes available, innovators will need to be ready to invent various creations in the health industry to aid in gaining control of novel coronavirus. Those in the medical device community can help by creating diagnostic technologies. The technologies would be most effective if they could be used quickly- similar to a swab test. The technology would be even more beneficial if the common person were able to use it, resulting in mass diagnosis. Although innovative medical devices would be useful, those diagnosed would still need treatment. Thus far in the treatment of novel coronavirus, care givers have only been able to treat the symptoms of the virus and not the virus itself. Despite researchers’ and pharmaceutical developers’ best efforts, there has yet to be a vaccine for novel coronavirus.

This ultimately leads to the question, how long? How long until medical device technologies and a treatment for coronavirus are available to the public? A troublesome question, with an even more troublesome answer. Even if research on the novel coronavirus became extensive enough to create medical devices or vaccines, these creations would still

have to undergo routine analysis and testing. Those of us in the medical device, pharmaceutical, and regulatory fields know that the process can be long and frustrating at times. The WHO has attempted to accelerate the process through releasing guidelines on subjects including rapid data sharing, research during infectious disease outbreaks, and emergency use of unproven treatments. As well, evaluators in the regulatory field have protocols in place to aid in accelerating the analysis, testing, and trial period of vaccines and technologies for disease outbreaks. Despite this, it is doubtful a vaccine will be available for several months. For now, all we can do is hope researchers and innovators are working together to share knowledge about the virus and can create solutions to this growing global health problem.

Please click on the links to see more information regarding the novel coronavirus from CBC News, the WHO, the CDC, and the Harvard Business Review. To see all the guidelines provided by the WHO for managing infectious disease outbreaks ethically 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

The post The Need for Pharmaceutical and Medical Device Advancements in the Race Against Coronavirus appeared first on Focal Point.

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

The post How to Handle Complaints Made About Your Innovation appeared first on Focal Point.