The possibility of a connection between the ongoing virus and the vitamin is undoubtedly fascinating, and likely stems from the fact that Vitamin D is known to have numerous health benefits; most notable in this case are its positive effects on the immune system function and its suppression of inflammatory processes (D, Amore, 2020). Vitamin D, which is actually a hormone produced by the kidneys, has long been theorized to have an encouraging effect on the human immune system and the ability to help fight off certain respiratory infections, including the common cold and flu (O’Connor. 2020). While results of these studies are typically inconclusive, it has rightfully so provoked questions within the scientific community which led to the completion of numerous scientific studies in order to uncover if any linkage between COVID-19 and Vitamin D can be determined, and if so, precisely what that relationship may be.

This conversation began back in March of this year, when one of the first studies was conducted by researchers at the University Hospital Marques de Valdecilla in Santander, Spain. In a quote to CTVNews.ca, author Dr. José Hernández stated, “There are numerous pieces of evidence in the literature that support the beneficial effect of vitamin D on the immune system, especially regarding protection against infections, including viral infections”. He, and several other researchers went on to examine the Vitamin D levels of 216 patients diagnosed with the coronavirus, as well as 197 additional individuals that acted as a control group, in order to analyze its effect on the severity of the virus (Hernández, 2020). The results of the study, published in The Journal of Clinical and Endocrinology & Metabolism, showed that 82% of the patients with COVID-19 were Vitamin D deficient, compared to 42% of the patients from the control group. Additionally, the results also indicated that the male patients diagnosed with COVID-19 exhibited exceptionally lower Vitamin D levels then their female counterparts, which was explained by one of the authors of the study as being due to many factors “including lifestyle or dietary habits and different comorbidities” (Hernández, 2020). While these results appear very compelling, it is important to note that the researchers behind this study made it clear they were not conclusive enough to determine any definite association between the virus and the vitamin, but rather, simply act as cause to ask more questions.

A similar study was completed at the University of Chicago Medicine throughout the months of March and April of this year, where the medical records of 4,300 individuals diagnosed with the coronavirus were reviewed, and, based on 499 of those individuals whose Vitamin D levels were tested within the past year, it was determined that ”people who were vitamin D deficient before the pandemic began were 77 percent more likely to test positive for COVID-19 compared to people who had normal levels” (O’Connor, 2020). While the lead author on this study, Dr. David Meltzer, theorizes that taking Vitamin D will cause individuals who contract the virus to exhibit fewer symptoms than those deficient in the vitamin due to “the immune system [being] less likely to have an exaggerated inflammatory response”, he ultimately echoed a similar message to that of the researchers at the University Hospital Marques de Valdecilla, which is that with the current data available the results of the study, while fascinating and undeniably noteworthy, are at best a sign of correlation and show no proof that one is caused by, or has any effect on the other (Meltzer, 2020).

One of the biggest challenges, according to Kelly Grindrod, a pharmacist, and professor at the University of Waterloo’s School of Pharmacy, is “pars[ing] out vitamin D from all the other risks and factors associated with COVID-19” (D’Amore, 2020). Numerous other pre-existing conditions have proven to affect how susceptible an individual is to contracting COVID-19, including diabetes, cancer, cardiovascular disease, and other respiratory ailments (D’Amore). Many of these are also associated with low levels of Vitamin D, making isolating out any one particular condition as the cause of the virus a very difficult task.

As a result, the nearly unanimous consensus with regards to a correlation between COVID 19 and Vitamin D appears to be twofold. First, that regardless of any potential links to COVID-19, Vitamin D has numerous proven health benefits, including helping your body absorb calcium and maintain strong bones and teeth, and people should therefore aim to get a sufficient quantity of Vitamin D on a daily basis, whether through sunlight, diet or supplement. For individuals over the age of 50, a daily supplement of 400 IU (10 µg) is recommended by Health Canada (Vitamin D). Second, that the current data available is insufficient to establish a definite relationship between the global virus and Vitamin D, and a significant amount of more research will need to be conducted, specifically in the form of randomized and properly executed control trials as opposed to simple observational studies, before any determinations are made regarding Vitamin D and its ability to prevent or lessen the severity of COVID-19.

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.

References:

D’Amore, R. (2020, July 30). Vitamin D and COVID-19: Experts say any possible link is ‘premature’. Retrieved from https://globalnews.ca/news/7229458/coronavirus-vitamin-d-studies/

Dunham, J. (2020, October 27). More than 80 per cent of hospitalized COVID-19 patients had vitamin D deficiency: study. Retrieved from https://www.ctvnews.ca/health/more-than-80-per-cent-of-hospitalized-covid-19-patients-had-vitamin-d-deficiency-study-1.5162396

Gruber-Bzura B. M. (2018). Vitamin D and Influenza-Prevention or Therapy?. International journal of molecular sciences, 19(8), 2419. https://doi.org/10.3390/ijms19082419

José L Hernández, Daniel Nan, Marta Fernandez-Ayala, Mayte García-Unzueta, Miguel A Hernández-Hernández, Marcos López-Hoyos, Pedro Muñoz Cacho, José M Olmos, Manuel Gutiérrez-Cuadra, Juan J Ruiz-Cubillán, Javier Crespo, Víctor M Martínez-Taboada, Vitamin D Status in Hospitalized Patients With SARS-CoV-2 Infection, The Journal of Clinical Endocrinology & Metabolism, , dgaa733, https://doi.org/10.1210/clinem/dgaa733

Meltzer, D. O., Best, T. J., Zhang, H., Vokes, T., Arora, V., & Solway, J. (2020). Association of Vitamin D Deficiency and Treatment with COVID-19 Incidence. medRxiv : the preprint server for health sciences, 2020.05.08.20095893. https://doi.org/10.1101/2020.05.08.20095893

O’Connor, A. (2020, June 10). Exploring the Links Between Coronavirus and Vitamin D. Retrieved from https://www.nytimes.com/2020/06/10/well/live/coronavirus-vitamin-d-immunity.html

Vitamin D. (2020). Retrieved from https://www.covid19treatmentguidelines.nih.gov/adjunctive-therapy/vitamin-d/

Vitamin D. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/services/nutrients/vitamin-d.html

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As the COVID-19 pandemic of 2020 continues to increase the demand for hand sanitizer, it is useful to understand how different hand sanitizers work and their properties. In this paper, we will explore alcohol and non-alcohol-based hand sanitizers as well as hand washing within the context of SARS-CoV-2, COVID-19 or coronavirus, as it is more commonly known.  

II) Background 

Most people are aware that ‘germs’ are what cause illnesses, or even more explicitly that these ‘germs’ consist of bacteria and viruses. Bacteria are eukaryotic cells, an enveloped cell containing cytoplasm and organelles. ¹ They can cause illness by causing damage to the host cell, the overall body of the host, or through the delivery of toxins within the body. Viruses are structures which contain RNA or DNA in a protein structure that is sometimes surrounded by a lipid bilayer. They cause illness by entering a host cell and replicating, which causes altered function, structure, or death of the cell.  

COVID-19 is a lipophilic enveloped virus. It is part of the coronavirus family; a family of viruses which cause upper respiratory problems such as the common cold, severe acute respiratory syndrome from SARS-CoV, and Middle East respiratory syndrome. ² These viruses can be referred to collectively as coronaviruses.  

Hand sanitizers sold in Canada must follow the antiseptic skin cleansers (personal domestic use) monograph from Health Canada. ³ The monograph permits hand sanitizers to contain ethyl alcohol (ethanol) at 60-80% and 2-propanol (isopropanol) at 60-75% as active ingredients.  Hand sanitizers that use alcohols as their active ingredients are classed as Natural Health Products. The monograph also allows other active ingredients; these hand sanitizers are classed as non-prescription drugs. These actives include benzalkonium chloride at 0.1-0.15%, benzethonium chloride at 0.05-0.5%, chlorhexidine digluconate at 2-4%, chloroxylenol at 0.5-3%, and triclosan at 0.1-1%. In the United States, hand sanitizers are considered OTC antiseptics. ⁴ The US FDA declares that a product can be marketed as a hand sanitizer if it contains ethyl alcohol, isopropyl alcohol, or benzalkonium chloride as the active ingredient. 

III) Effectiveness of Alcohol-Based Hand Sanitizers 

Currently, many alcohol-based hand sanitizers use ethanol (ethyl alcohol) or isopropanol (isopropyl alcohol) as their active ingredient.⁵ These alcohol- based hand sanitizers have strong bactericidal properties when the active ingredient is within a 60-90% concentration within the product.⁶ The bacteriocidic properties come from the alcohols’ ability to denature bacterial proteins, resulting in their death. Alcohol-based hand sanitizers are also viricidal at alcohol concentrations between 60-80%. These alcohol-based hand sanitizers demonstrate strong viricidal and bactericidal properties even with a short period of contact. In fact, ethanol at concentrations between 62-71% have been shown to reduce coronavirus infectivity within one minute of exposure time by 2.0–4.0 log10. ⁷ 

In a study conducted by H.F. Rabenau et al. in the Efficacy of Various Disinfectants Against SARS Coronavirus, several different disinfectants were tested against SARS-Cov, including sanitizers based on ethanol. It was found that the sanitization products inactivated the SARS-CoV below the limit of detection. ⁵ This is an indication that ethanol-based hand sanitizers should also have an impact on the virus behind COVID-19 as the two demonstrate similar stability patterns on surfaces.⁸ Finally, it was found in a comparison study that although alcohol-based hand sanitizers that use ethanol or isopropanol are both effective, ethanol has been experimentally determined to be more effective within a shorter period of time.⁹ 

IV) Effectiveness of Non-Alcohol-Based Hand Sanitizers 

An alternative to alcohol-based hand sanitizers is non-alcohol-based hand sanitizers, which commonly consist of active ingredients benzalkonium chloride or benzethonium chloride. Hand sanitizers and other sanitization products based on these ingredients are known more for their impacts on bacteria than on viruses. 

The bactericidal actions of benzethonium and benzalkonium chloride comes from their ability to inactivate energy producing enzymes, denature essential proteins, and ultimately cause damage to the bacterial cell membrane.⁶ Due to the multiple levels of bacterial destruction that benzethonium and benzalkonium possess, they are considered better at managing bacteria than alcohol-based products, in certain cases. For example, benzethonium chloride is more effective than ethyl alcohol below 70% in destroying serratia marcenscens, a bacteria. ¹⁰ In fact, one test showed that benzethonium chloride destroyed the bacteria at 1.60 log, while alcohol cleansers such as ethyl alcohols below 70% only destroyed the bacteria below 1.55 log. This shows that non-alcohol-based hand sanitizers demonstrate strong bacterial destruction against some bacteria. With this being said, it is important to use these sanitization products only when necessary as it has been found that bacteria have begun adapting to overcome these methods of destruction. ¹¹ 

In addition to benzethonium or benzalkonium chloride-based products’ efficacy against certain bacteria, they are also effective against some viruses. ¹²  Specifically, benzethonium and benzalkonium chloride-based products have been shown to kill lipophilic and enveloped viruses. The mechanisms through which the chloride ingredients kill viruses requires the virus membrane to attract the benzalkonium molecules, which causes the initial damage to the virus membrane, resulting in apoptosis of the virus cell. As SARS-CoV-2 is an enveloped virus, these products would be expected to be effective in preventing Covid-19.¹³ 

It has been found that benzalkonium and benzethonium chloride products work better with longer contact. As such, these products can be found in surface cleaners more than hand sanitizers. It should also be noted that in some countries, hand sanitizers based on benzethonium and benzalkonium chloride cannot be advertised as a prevention against Covid-19.¹³ Although it has been hypothesized that these products have an effect against COVID-19, there are currently no studies that have clearly identified this. Therefore, regulatory bodies like US FDA and Health Canada encourage the use of an alcohol-based hand sanitizer over a non-alcohol-based hand sanitizer whenever possible, as non-alcohol-based hand sanitizers are ‘less reliable for tackling Covid-19′ (CDC, 2020). ¹⁴ 

V) Absorption of Ethanol through the Skin 

The question that is raised from time to time is whether or not ethyl alcohol can be absorbed through the skin and have health impacts on vulnerable groups, such as women who are pregnant or lactating. Evidence does not support this. Studies have shown that alcohol from hand sanitizers does not absorb in any significant quantities through the skin.¹⁵ Even with damage to the epidermis, dermis, or the frequent use of hand sanitizers, the slight alcohol absorption is still limited and does not cause a clinical concern.  

Other than the oral route, ethanol can be inhaled when boiled. Gaseous ethanol reaches pulmonary circulation from the alveoli in the lung. It can then pass directly via the pulmonary vein into the left ventricle and from there to the brain (without first-pass metabolism). However, this is not a concern as the levels inhaled from hand sanitizer at room temperature do not cause a significant blood-alcohol level to be of a clinical concern. Therefore, the choice between alcohol and non-alcohol-based hand sanitizers should not be decided through the consideration of safety, as both are safe even for vulnerable groups. ¹⁶ 

VI) Hand Washing 

It is important to understand that despite the effectiveness of hand sanitizers, the best method for removing traces of COVID-19 is thorough hand washing.¹⁷ This is due to the similarities between lipid bilayer membrane of the virus and the structure of soap and synthetic detergents. Soap attracts the virus membrane which causes unrepairable damage to the virus membrane killing it or making it nonvirulent. The use of water further aids in the destruction as it dissolves the virus, destroying it further. Additionally, the mixture of water and soap running off the hands carries the virus and its debris with it, further decreasing the chance of infection. ¹⁸ This is unlike hand sanitizer as although the virus is no longer a significant source of infection, the ‘dead’ viruses remain on your hands. Therefore, it is always best to choose hand washing rather than using hand sanitizer whenever possible.  

VII) Conclusions 

In the end, it is expected that both alcohol and non-alcohol-based hand sanitizers are likely to be effective in the defense against COVID-19. Alcohol-based hand sanitizers have been found to be more effective against this family of viruses than non-alcohol-based hand sanitizers, especially those containing ethanol as the active ingredient. Non-alcohol-based hand sanitizers with active ingredients such as benzalkonium and benzethonium are expected to still be effective against COVID-19, as it is an enveloped virus. Both types of hand sanitizers are safe for use as active ingredients are used within safe limits and have shown to not cause any clinical concerns. However, hand sanitizer should only be used secondary to hand washing as hand washing has been shown to be the most effective method against COVID-19.  

For more information, please contact Focal Point Research Inc at mail@focalpointresearch.net. 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. 

References  

1. Kumar, V., Abbas, A. K., Aster, J. C., & Robbins, S. L. (2018). Robbins Basic Pathology. Amsterdam: Elsevier. 
2. Coronaviruses. Retrieved July 30, 2020, from https://www.niaid.nih.gov/diseases-conditions/coronaviruses 
3. Government of Canada, H. (2007, May 08). Antiseptic Skin Cleansers (Personal Domestic Use). Retrieved July 30, 2020, from http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique 
4. Commissioner, O. FDA issues final rule on safety and effectiveness of consumer hand sanitizers. Retrieved July 30, 2020, from https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers 
5. H.F. Rabenau., G. Kampf., J. Cinati., H.W. Doerr. Efficacy of various disinfectants against SARS coronavirus. 61 (2005), 107-111. 
6. Chemical Disinfectants. (2016, September 18). Retrieved July 30, 2020, from https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/chemical.html 
7. G. Kampf., D. Todt., S.Pfaender., E. Steinmann. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. 104 (2020), 246-251. 
8. Seladi-Schulman, J. (2020, April 03). Coronavirus vs. SARS: How Do They Differ? Retrieved July 30, 2020, from https://www.healthline.com/health/coronavirus-vs-sars 
9. Yashpal S. Malik BVSc, PhD., Sunil Maherchandani BVSc, PhD., Sagar M. Goyal BVSc, PhD. Comparative efficacy of ethanol and isopropanol against feline calicivirus, a norovirus surrogate. 34 (2006), 31-35. 
10. Sickbert-Bennett. E., Weber. D., Gergen-Teague. M., Sobsey. M., Samsa. G., Rutala. W. Comparative efficacy of hand hygeine agents in the reduction of bacteria and viruses. 33 (2005), 67-77. 
11. Jackson, M. Safety and Effectivemess of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. (2018).  
12. Golin, A., Choi, D., & Ghahary, A. (2020, June 18). Hand sanitizers: A review of ingredients, mechanisms of action, modes of delivery, and efficacy against coronaviruses. Retrieved July 30, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301780/ 
13. Center for Drug Evaluation and Research. QAs Hand sanitizer and COVID-19. Retrieved July 30, 2020, from https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19 
14. Murugesu, J. Hand sanitiser. Retrieved July 30, 2020, from https://www.newscientist.com/term/hand-sanitiser/ 
15. Brewer, Colin., Streel, Emmanuel. Is Alcohol in Hand Sanitizers Absorbed Through the Skin or Lungs? Implications for Disulfiram Treatment.  55 (2020), 354-356.  
16. Evans, Virginia A. MD; Orris, Peter. The Use of Alcohol-Based Hand Sanitizers by Pregnant Health Care Workers. Journal of Occupational and Environmental Medicine. 54 (2012).  
17. Rigby, S. (2020, April 20). Coronavirus: Is hand-washing really the best thing we can do to stop the spread of COVID-19? Retrieved July 30, 2020, from https://www.sciencefocus.com/news/coronavirus-can-hand-washing-really-stop-the-spread-of-covid-19/ 
18. Welsh, E. (Co-host)., Allmann Updyke, E. (Co-host)., Rasmussen, A. (Guest). (March 23, 2020). ‘COVID-19 Chapter 1: Virology’ This Podcast Will Kill You [Audio podcast]. Retrieved from https://thispodcastwillkillyou.com/2020/03/23/covid-19-chapter-1-virology/ 

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The Canadian Government released a contact tracing app called COVID Alert. After downloading the app, the app notifies you if you have possibly been exposed to someone with Covid-19. This is beneficial as symptoms of Covid-19 can appear days later or in some cases with symptoms not appearing at all. Many Canadians are wary about the app, believing it is too invasive. However, this should not be a concern as the app does not know your location, name, address, or your health information. The app uses Bluetooth to exchange codes with phones nearby and checks everyday if any of the codes It has received have identified as Covid-19 positive within a 14-day range. If it has, you will be notified. It should be noted that this app is not intended to replace manual contact tracing, nor does it replace medical advice. If you are feeling unwell you should still see a doctor or healthcare provider, and local public health authorities will conduct manual contact tracing if you are diagnosed with Covid-19.  

Apple Inc. Collaborated with the White House Coronavirus Task Force and the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), to create an app which guides its users through a Covid-19 screening questionnaire. The result of the questionnaire indicates if you should seek medical care for your symptoms.  The app also provides recommendations for social distancing, self-isolating, how to monitor symptoms, and when it is recommended, to contact a medical provider. Apps such as these are especially important in situations where screenings, tests, or medical care can be costly or unaffordable for families.  

The common theme between the two apps is that they are only good if people use them. It is important for your own safety and the safety of your community to monitor your symptoms and conduct Covid-19 safe practices, and these apps are there to help.  

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 usual process, a vaccine takes about an average of 10 years to be created. However, since this vaccine is needed quickly, this process has been fast-tracked. This process includes; Preclinical testing, where scientists give the vaccine to see if animals produce an immune response; Phase I when scientists conduct safety trials in which a small number of people are given the vaccine to ensure an immune response will occur; Phase II, which involves expanded trials with the testing of many people from various age groups;  and Phase III, where the vaccine is distributed to thousands of people and the results are compared to those who receive a placebo. It should be noted that during phase II, a certain amount of the test population must experience an immune reaction for the vaccine to be considered effective. For example, a COVID-19 vaccine in the United States must demonstrate an immune response in 50% of the population to be deemed effective.  Once a vaccine has gone through this process, it can then be approved for use.  

Despite the extensive testing process, there are already many vaccines in the beginning stages of this process. There are currently 142 vaccines in pre-clinical evaluation, twenty-four in phase I, fifteen in phase II, and four in phase III. These vaccines have various mechanisms of action, which are controlled by the type of virus included in the vaccine. The virus in the vaccine could be the full inactivated virus, a live attenuated virus, or parts of the virus such as protein, DNA, or a non-replicating viral vector. A list of the types of vaccines and their stages can be found here.  

Recently, the most promising vaccine appears to be one from the University of Oxford that is licensed to AstraZeneca. The vaccine has demonstrated efficacy in early stage testing. Although there seems to be a front runner, it is very possible that multiple vaccines with different mechanisms will be successful and distributed. This will help meet demand and help us return to our usual lives faster.  

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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You still must have a product license, signified by an NPN, to manufacture, distribute, or import alcohol-based hand sanitizer. There are no additional labelling requirements from those previously outlined for hand sanitizers in the Guide on Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers.  The guide includes a sample formulation as well. Finally, Health Canada declared in the guide that interim measures will cease once regular supplies stabilize. Any questions regarding the guide should be relayed to hc.nnhpd-dpsnso.sc@canada.ca .

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 productsregulated by Health Canada and the U.S. FDA.

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The United States government has released their three staged plan for re-opening the country. There are certain criteria and preparedness that are required prior to the beginning of the first re-opening phase. Included with the release of the re-opening plan are guidelines for individuals, employers, and specific places for each phase. As well, the US government has released public sanitization guidance that can be found here. This document specifies cleaning and disinfecting regulations for public spaces, workplaces, businesses, schools, and homes.  

Ultra Beauty, an American beauty salon retailer, has released their plan for re-opening stores. In fact, in several states in which salons, barbershops, and spas are already open, Ultra Beauty has begun re-opening their stores as well. Their re-opening strategies are based on advice and guidelines from governments, health sources, and Retail Industry Leaders Association. Associates of the establishments must wear masks, gloves, and undergo a mandatory wellness check prior to their shift. The customer experience will be different as well as they are encouraged to wear masks, perform social distancing, and book appointments for salon services. The store has removed all product samplers/testers and has provided hand sanitizer throughout the store.  

Makeup may not be the first priority for some customers as society opens; their priority will be their hair. In fact, Kantar Research identified that beauty therapy, such as barbers and salons, will experience the highest activity during re-opening. Salons and barbers are theorized to be in higher demand than even restaurants and socializing establishments. Luckily, L’Oréal collaborated with Nation Hair and Beauty Federation and British Beauty Council to release a support guide for barbers which follows United Kingdom guidelines. The guide advises business owners on how to organize bookings, payments, and how to ensure proper sanitization practices are performed, such as tool disinfecting. L’Oréal believes that these new measures will not only increase safety for employees and customers, but it will also promote a supportive and connected workplace for staff.  

Practices such as these will likely become very common in society as countries re-open. However daunting these practices seem, they are necessary and helpful for protecting the wellbeing of society while attempting to maintain a successful economy. These practices seem achievable with policies, guidelines, and examples such as Ultra Beauty and L’Oréal to help guide us through the re-opening of the cosmetic and beauty industry into this new normal.  

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 decline in the biomedical technology industry was seen in the last weeks of March due to an overall decline in sales, procedures, and testing. As well, many hospitals restricted their surgeries to only necessary surgeries to preserve resources and staff. This resulted in great losses for hospitals and suppliers. However, the losses for hospitals continued through the cost of increasing PPE, reconfiguring spaces, new medical equipment, and the need for increased labor. Although some hospitals have started to allow elective surgeries to begin, such as hospitals in China, the surgery rate has not returned to its normal amount. It has been theorized that this is from consumer hesitation and concern of safety. Therefore, although the decline is lessening, it may still be a while until the biomedical technology industry and hospitals return to normal. 

With that being said, certain biomedical technology companies have actually experienced a dramatic increase in sales in certain departments. Companies that were already producing products that could aid in the coronavirus pandemic, such as assistive breathing and intensive care devices, have experienced an increase in profit caused by the high demand.  For example, Hillrom, a producer of non-invasive ventilators, patient monitoring devices, and smart beds, experienced an extreme increase in sales. In fact, the company increased ventilator production by fivefold and are hiring temporary and permanent employees. 

Other biomedical technology companies have experienced a market gain through the creation of precautionary medical equipment, such as Hologic. Hologic developed a SARS CoV-2 diagnostic test that is compatible with many hospital’s systems. The test produces results within three hours. Since the release of the test, the company has experienced their highest groth rate in eight years and has increased their production of the tests by 12-fold. 

People have recognized this ability to succeed in the biomedical technology industry during this time, but some people have been dishonest when trying to find success. As such, the US FDA has seen an increase in fraudulent products. An explanation of the US FDA’s guidance for innovators and researchers can be found  here. Therefore, although the biomedical technology field can help greatly during this difficult time, it is important to remember the regulatory steps required in the process. 

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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However, due to the short-term success of meeting demands, Health Canada has recently announced the ending of two of the interim regulations for the hand sanitizer and disinfectant product regulations; allowing unilingual labelling for hand sanitizers being sold within a unilingual region and turnaround time of 24 – 48 hours for site licence and product licence applicants. All labelling for hand sanitizer and disinfectant products in Canada must immediately change their labelling to be in both English and French. Those who are currently licensed have until June 8, 2020 to comply with bilingual labelling requirement. All new products going forward will have to comply with this immediately. Please refer to the monograph for the complete labelling regulations for hand sanitizers. As well, the previous quick turnaround time of 24 – 48 hours for site licence and product licence applicants has been removed too. The new regulation states the turnaround time is now approximately 5 – 7 days. This was outlined in Health Canada Bulletin #17 – dated May 14, 2020.

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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Health Canada has provided interim expedited licensing to support facilities to manufacture, package, and label alcohol-based hand sanitizers during this desperate time of need for these products. It should be noted that hand sanitizers containing ethanol labeled as ‘anhydrous alcohol’, ‘ethyl alcohol’, or ‘grain alcohol’ are considered Natural Health Products (NHPs). Hand sanitizers containing isopropanol labeled as ‘isopropyl alcohol’ or ‘2-propanol’ are considered NHPs as well. A Site Licence (SL) is required to import, manufacture, package, or label hand sanitizers in Canada while a Product Licence is required to distribute and sell hand sanitizers. The final hand-sanitizer product should be 60-80% ethanol or 60-75% isopropanol, as per the Antiseptic Skin Cleansers (Personal Domestic Use) Monograph. The hand-sanitizer must also fully comply with the monograph in order to qualify for the expedited process onto the Canadian market. It should be noted that Health Canada still requires the reporting of adverse reactions to products, if any develop. These temporary regulations will be in place until March 31, 2021 or until a statement is made from Health Canada to licence holders regarding timelines and next steps for this interim process.

For Site Licences, companies must state which Good Manufacturing Practices (GMPs) they are attesting to when completing the application. This may be part three of the NHPR, Division 2 of Food and Drug Regulations, Guide to Food Safety, or Good manufacturing Practices for Cosmetic Products. Certain GMPs, such as stability testing and providing GMP evidence such as Quality Assurance Reports (QARs), are temporarily waved. With that being said, facilities should ensure that the appropriate controls are in place to avoid product contamination.  The Health Canada guidance document also includes details about Product Licence Applications (PLAs) and instructs to include that the application type is ‘Compendial’ and is a ‘Antiseptic Hand Cleanser’. The primary brand name should indicate generic descriptor of the product as well as alcohol content and should not have any reference to the coronavirus or any specific virus directly. The medicinal ingredients should only include ‘ethanol’, ‘ethyl alcohol’, ‘isopropanol’, or ‘isopropyl alcohol’ within the quality per dosage unit, as indicated above. If these measures and details are properly followed, the Product Licence for the hand sanitizer product should be made available quickly.

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 Guidance Document on Interim Expedited Hand Sanitizer Approval Process appeared first on Focal Point.

To begin, the United States has allowed non-traditional drug manufacturers to produce hand sanitizers, with the condition of following FDA guidance and registration procedures. The hope is that these more relaxed measures will allow a greater volume of hand sanitizer production and distribution (a key component in the fight against coronavirus).  The United States will also temporarily suspend all domestic routine facility inspections. This will allow for maximum physical distancing, and non-essential personnel to be able to remain at a distance.

The E.U. has also taken steps to aid the community through this troubling time. The European Chemicals Agency has announced their support of EU/EEA authorities in applying exemptions from normal authorization to speed up the process of disinfectants, such as hand sanitizers, during the pandemic. As well, the European Commission presented new temporary guidelines to ensure the continuous flow of goods across E.U. borders. These guidelines include minimizing procedures for checking transport trucks and their drivers to what is necessary.

Finally, Canada has also taken steps in updating their regulatory processes in order to provide ease during this time. Health Canada has streamlined the process for importing non-prescription drugs with the hope of making import of high demand of non-prescription products easier and quicker for consumers. Along the same lines, Health Canada has temporarily allowed exemptions for importing and releasing disinfectant and sanitization products onto the Canadian market by alleviating and reducing the normal authorization and approval procedures for disinfectant and sanitation products.

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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