The establishment of these NSRLs provides a clear ‘safe harbor’ threshold for businesses. If exposure from a product is below these levels, a Prop 65 warning for cancer risk is not required.

The New NSRLs:

The OEHHA has set two distinct daily exposure limits based on particle size:

• 440 micrograms per day for airborne, unbound titanium dioxide particles with diameters of 10 micrometers or less
• 44 micrograms per day for airborne, unbound titanium dioxide particles with diameters of 08. micrometers or less

Please contact us if you would like assistance with formula reviews or exposure assessments to ensure compliance with Prop 65.

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At the beginning of the Covid 19 pandemic, there was tremendous panic because of the shortages of Personal Protective Equipment of all types. Since then, most countries have ramped up production of all types of equipment for both medical professionals and the public at large.

During the past year, the scientific community learned that Covid 19 spreads through droplet transmission in the air rather than on surfaces. This is caused a dramatic shift away from hand and surface sanitization to protecting individuals from inhalation of the virus. Recently several companies have developed new and higher performing products that not only claim to work better than basic facemask technology, they also offer superior comfort. One is a hood/helmet type product, the other a complex face mask.

Vyzr Technologies in Toronto Canada (www.vyzrtech.com) has developed the Biovyzer. Their product is a Powered Air Purifying Respirator (PARP) which is essentially a hood that slips over the head and contains the entire airspace around the head. It is a battery-operated device that cleans incoming air through a filtration system, and again filters outgoing air. It has an innovative “glove” that allows the wearer to scratch the face, adjust their glasses etc. At a cost of $379 plus shipping, it may be out of reach for many consumers but it offers a high-tech solution that could fill a major niche in healthcare, commercial and industrial settings. It could also be a game changer for immunocompromised individuals.

Another interesting innovation comes out of Florida’s Octo Safety Devices (https://octosafety.com/pages/the-octo-respirator-mask). Their product is more of a face mask, but with several interesting, innovative features. It is a multicomponent mask with a reusable, cleanable filter. The filter uses silver particles for antimicrobial effectiveness. There is a soft silicone skirt that sits against the face which would appear to be both comfortable and able to provide an effective seal. The product also has a mouth vent which the manufacturer claims that it allows people to speak more easily through their masks. At $107, it is also a premium product but one that could be well worth the cost if it performs as the manufacturers describe.

These are just two examples of the countless innovations in development since the beginning of the Covid 19 pandemic. Both companies mentioned here are small, innovative businesses who deserve much credit for their work.

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 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. 

The post The Progress in The SARS-Covid-2 Vaccine appeared first on Focal Point.

Along with the addition of sunscreen to one’s daily routine, many people change their products involved in their daily routine. This may mean switching to lighter skin products such as a lighter foundation, tinted moisturizer, or BB cream in place of thicker makeup. Some use waterproof or smudge proof makeup to maintain a makeup look despite the sweat that comes with the heat of the season. Those who find sunscreen to be too heavy in the summer may be interested to know that there are powdered sunscreens available that are perfect for protecting your face, but also places sunscreen can’t necessarily be applied such as a hair part. One may also consider using a moisturizer with SPF to aid in lightening their skin routine. 

In addition, dermatologists recommend lightening your skin cleaning products, switching from cream/oil products to foaming ones. As well, dermatologists have said that vitamin C has been seen to prevent hyperpigmentation, improve fine lines, and aids in collagen production, making for stronger, healthier looking skin when applied topically. Finally, exfoliation can aid with minimizing the impacts of oily skin. If exfoliation is something you normally do, dermatologists recommend slowly increasing the frequency of exfoliation in your routine to combat the increase of oils on skin that come with the warm weather. In the end, there really is much more than just sunscreen to protect yourself in these coming warm months. So be safe and enjoy it! 

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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During this time of increased cannabis cosmetic products, there have been many changes to regulatory protocols internationally, which we have previously reported on. The original varying regulatory protocols made the market for cannabis containing cosmetics more accessible for independent manufacturers rather than international cosmetic manufacturers. However, as regulations have become more solid and clear throughout the years, both independent and international companies entered the cannabis cosmetic market.

A recent example of an international company entering the cannabis cosmetic market is Colgate with their new Hello Products. This line of products includes oral care and lip balms containing CBD. The oral care line comprises of mouthwashes and toothpastes both with and without fluoride. Avon has also recently released a CBD line of topical creams in their new distillery collection. These creams have been advertised to promote hydrated and healthier looking skin. Some international companies not only had to overcome complicated regulations, but complications in formulations. For example, earlier this year Gelest created a new CBD isolate that was compatible with their silicone-based products.

Despite the extreme success, there are still some gaps in our knowledge regarding CBD in oil drops, foods, cosmetics, topical lotions, and creams. The US FDA continues to research the effects of cumulative use, co-administration with other drugs, and impacts on vulnerable populations such as children and pregnant women. Overall, the FDA suggests consulting with a medical physician before beginning to use any cannabis products. There is also research outside of the government, such as the research at the University of Mississippi. There, scientists are exploring various levels of CBD and THC

in cosmetic products and their dermal penetration. In the end, the cannabis cosmetic market is will continue to gain momentum and the research behind it is advancing to support it.

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 Cannabis in Cosmetics; Where Are We Now 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

The post A Summary of International Efforts in Minimizing the Spread of COVID-19 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

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