Posts tagged with "FDA"

CBD Health illustration for 360 Magazine

Best CBD Salves

Best CBD Salves: Top Brands in 2021

At some point in their lives everyone deals with sore muscles, achy joints, and dry, chapped skin. However, finding relief can sometimes be a challenge. Harsh ingredients irritate the skin, and watery formulas have no effect.

People are looking for a solution. They want a product that works with the body’s natural defenses to reduce pain and inflammation while also nursing the skin. Products made with CBD targets problem areas by penetrating the skin’s layers for healing and relief.

But, finding the best CBD salve isn’t always easy because not all CBD salves are created equal. Several companies manufacture CBD products that contain very little CBD, or the CBD is low-quality and combined with harmful ingredients.

This article looks at the different CBD salves on the market, and determines what makes one CBD topical salve better than others. The objective of this article is to educate readers on how to choose a high-quality salve, explain what is in a salve, and determine if a salve is the right choice for their type of pain. Additionally, this piece will explain the benefits and side effects of CBD topicals.

Keep reading to discover our top picks for the best CBD salves and learn how we chose them.

What Are CBD Salves and Topicals?

Many people are already familiar with CBD that can be taken orally: such as tinctures, gummies, or vape cartridges. CBD topicals are products that contain CBD for application to the skin. Topicals come in many forms, such as creams, lotions, balms, and salves.

Creams and lotions combine oil and water, along with an emulsifier. Creams have a higher ratio of oil to water, whereas the ratio is vice versa for lotions. Manufacturers formulate lotions and creams to absorb quickly into the skin.

In contrast, salves and balms typically contain CBD, herbal remedies, and some type of wax–such as beeswax. Salves usually have a softer consistency than balms.

When Looking for a High-Quality CBD Salve?

Here are things to consider when choosing high-quality CBD salve for you:

The type of CBD

Previously, we discussed the difference between full spectrum, broad spectrum, and CBD isolate. Many people prefer full spectrum CBD because they are getting all the beneficial chemical compounds found in the hemp plant, including minute traces of THC. For people who want their products to contain only the CBD from the hemp plant and no other cannabinoids, CBD isolate is their preference.

The amount of CBD

CBD topicals come in varying strengths. The more CBD a product contains, the more potency it has. For first-time CBD users, it’s always best to start with the lowest strength and increase dosage until reaching the desired effect. Since many companies offer money-back guarantees, it’s easy finding the CBD strength that’s right for you.

Desired outcome

The primary purpose of using a CBD salve is to provide relief from pain. However, other benefits depend on the other added ingredients. Some people prefer a heating or cooling sensation, or alternate between both. Yet, others enjoy a calming scent that will help them to calm their minds and relieve stress. Many users of CBD topicals like to have their skin feel nourished and moisturized.

Price

CBD Salves tend to be more expensive than other topicals that are mass-produced and found in large box stores. The best CBD companies use high-quality hemp and organic ingredients to make their salves. They also do a considerable amount of research and testing to produce a CBD salve that’s safe and effective. If a store is advertising the “cheapest CBD products in town,” the product likely contains little CBD and inferior ingredients.

Our Criteria for Choosing The Best CBD Salves In 2021

In recent years, several CBD companies have come onto the market.  Knowing what to look for can seem like a daunting task.  It may seem easy to choose the first item during a web search or to stop by a nearby corner advertising CBD products. However, to make sure you’re purchasing a high-quality CBD salve, you will want to consider the following:

Where Does the Company Get its Hemp?

The 2018 Farm Bill made the cultivation of industrial hemp legal in the United States. It states that farmers can apply for a license to grow hemp and that the hemp can’t have THC levels above 0.3%. The Department of Agriculture regulates the industrial hemp industry, so all hemp produced in the US must meet USDA standards.

Several companies import their hemp from China, Canada, and the EU.[1] Many foreign countries do not have the same regulations and oversight as hemp grown in the United States.  The hemp in their products might contain heavy metals, pesticides, or toxins.

How Does the Company Extract the CBD From the Hemp?

There are several methods for extracting CBD oil from the hemp plant and some of those ways are less expensive than others. These methods usually involve using a solvent, such as ethanol or isopropanol. The problem with these extraction methods is that they destroy the hemp plant, and the solvents tend to bind to some of the plant’s components. What is left is a product that may be lacking in potency and purity.[2]

Alternatively, CO2 extraction is more expensive. It uses pressurized carbon dioxide to isolate and extract the beneficial cannabinoids from the hemp, without damaging the plant. The result is a high-yield, high-quality CBD oil that is pure and potent.

Does the Company Do Third-Party Testing?

CBD companies don’t have the same types of regulations under the FDA as drugs, and some brands make misstatements on their products. Legitimate CBD companies have their products tested by a third-party independent lab. These labs test the products for potency, ensure the THC level is below 0.3%, and checks for heavy metals, chemicals, and pesticides. Look for the company’s Certificate of Analysis (COA) on its website.

What Other Ingredients Are in The Salve?

Many brands of CBD salves contain other ingredients to enhance its effects. Look for products that contain organic and natural ingredients, such as botanicals and essential oils, and try to stay away from brands that contain chemicals and synthetic additives

What are Other People’s Opinions?

While it’s a good idea to read the reviews on a company’s website, it’s also essential to search the web for independent reviews. See what other people say about the company, the product, and the customer service.

However, keep in mind that a product that works for someone else may not work for you. You may have to try a couple of different brands before finding the product that is effective for your issues.

Best CBD Salve Brands in 2021: Our Top Picks

We considered all the previous factors, along with others, and compiled our list of the five best CBD salve brands on the market.  These products come from reputable CBD companies and have been shown to be effective in treating pain relief.  These CBD Salves have received favorable reviews from users of all ages.  They’re used by athletes, office workers, outdoor enthusiasts, and knitters.  These are our top choices.

Fab CBD

Fab CBD offers a full spectrum body salve. It comes in a roll-on, so it is easy to target sore muscles. While many other salves provide cooling or heating, Fab CBD Salve offers both. It contains Menthol Crystals for cooling and Cinnamomum Camphora Oil for heating. It also includes other organic essential oils and terpenes to soothe aching muscles and relax the body and mind.

  • Available in 1000mg and 3000mg full spectrum CBD
  • Convenient to carry in a backpack or gym bag
  • Great for weekend warriors or to relieve everyday aches and pains
  • It contains Rosemary, Ginger, Lavender, Eucalyptus, Organic Peppermint, Organic Tea Tree, and Organic Lemon Grass Oils to soothe skin and reduce inflammation
  • CBD extracted from hemp organically grown in Colorado
  • Roll-on applicator means less mess

Joy Organics

Joy Organics CBD salve combines broad-spectrum, premium-grade CBD with organic beeswax and essential oils. It absorbs quickly into the skin to relieve aching muscles, while the scent of lavender and eucalyptus promotes a feeling of relaxation.

  • CBD salve comes in strengths of 500mg and 1000mg
  • All of Joy Organics hemp is grown in the United States and is USDA Certified Organic
  • Joy Organics offers free shipping on all orders
  • All the ingredients in Joy Organics CBD Salve are organic
  • Joy Organics CBD Salve is high quality but is less expensive than many other competitors

CBDistillery

CBDistillery has all-natural ingredients in its CBD Relief Salve. Full-spectrum CBD absorbs quickly into the skin for incredible pain relief. Olive, Coconut, and Jojoba oils combine with Vitamin E to moisturize the skin.

  • Customers can choose from three strengths: 500mg, 1000mg, and 2000mg
  • CBD extracted from hemp grown organically in Colorado
  • The direct use of an essential skin care component like Vitamin E makes this cream a must have
  • Hemp is non-GMO and contains no animal by-products
  • CBDDistillery offers free shipping

What Are CBD Salves Generally Made From?

The main ingredient in CBD Salves is Cannabidiol (CBD) from hemp. CBD is one of over 100 chemical compounds in the cannabis plant. There are three different types of CBD that companies use in their products.

Full Spectrum

Full spectrum CBD is the least processed of all the extraction types. It contains all the cannabinoids, terpenes, and flavonoids from the hemp plant. It may also trace amounts of THC, the chemical compound found in cannabis with psychoactive properties. However, that trace amount is below 0.3% and is not enough to give users a feeling of being high. Full spectrum CBD allows for the entourage effect, that is, all parts of the hemp plant working together for maximum benefit.

Broad Spectrum

Broad spectrum CBD is very similar to full spectrum. However, it goes a little further in the extraction process to remove all traces of THC. Users can experience all the other beneficial components of the hemp plant without worrying about having any THC in their system.

CBD isolate

CBD isolate is the most processed of three types of extraction. CBD isolate is as the name suggests. All the other cannabinoids, including THC, along with the terpenes and flavonoids are entirely removed, leaving only the CBD.

Next, the company may combine natural botanicals with the CBD. These are essential oils from plants that people have been using for centuries for their therapeutic properties, such as Lavender, Rosemary, or Eucalyptus. Mixing the botanicals with CBD provides added relief and calming.

Some essential oils are potent and may be irritating to the skin in pure form. Therefore, manufacturers add carrier oils to the CBD. Jojoba oil, sweet almond oil, olive oil, or coconut oils are typically used as carrier oils, though there are several other choices.

Last, salves contain some type of wax, usually beeswax. The beeswax gives the salve its firmness. The wax’s primary purpose is to provide a skin barrier to allow the CBD and botanicals to absorb into the skin.

How to Apply CBD Salve, Lotion, And Cream?

There are several application methods for applying CBD salves, lotions, and creams. Some CBD topicals come as a roll-on, allowing the user to roll the salve onto the affected body part with no mess. This method is ideal for people traveling or on a hike or bike and need quick relief.

Another method preferred by many is to use a spatula to scoop out a small amount and apply it to the skin in a thin layer. However, most people use their fingers to apply the salve and massage it in.

No matter what the application method is, users should use the following steps in applying a CBD salve, lotion, or cream.

The first step is always to wash your hands to prevent any germs or bacteria from transferring from your hands to the CBD topical.

Next, wash and dry the affected body part. Using an applicator, clean spatula, or your fingers, take a small amount of salve and apply it where needed. Always start with a small amount and add more if it’s needed. Slowly and gently, rub it in so it can permeate the skin.

Wash your hands (and spatula) and wait a few minutes. Pain relief should happen in a short amount of time. Re-apply a few times throughout the day, as needed.

What Are The Benefits Of Applying CBD Salves?

Many people are curious why applying salve containing CBD is more beneficial than other mass-market-produced topicals, especially if they aren’t sure what CBD is and how it works.

To understand how CBD works, a person needs to know about the body’s Endocannabinoid System (ECS). Three components form the ECS.

There are receptors on the surface of the cells throughout the body. They monitor the body’s functions and keep alert for any changes in condition. The two types of receptors are the CB1 receptors in the central nervous system and the CB2 receptors in the peripheral nervous system.

When the receptors sense that a condition has changed in the body, they send out a message. At that point, endocannabinoids will come and bind to the receptors and work to bring the affected area back into homeostasis. Once the endocannabinoid’s job is complete, the enzymes break them down.

Researchers believe that the CBD works with the ECS to prevent the enzymes from breaking down the endocannabinoids, allowing them to work longer.

The skin is the body’s largest organ with a large concentration of CB2 receptors. When someone applies CBD topicals to the affected body part, the CBD can go directly to those receptors and provide fast relief.

Do Salve CBD Products Have Side Effects?

There are no known side effects from using products containing CBD. Additionally, there is little to no THC in CBD products, so people using CBD don’t need to worry about any psychoactive effects.

However, everyone has a different skin type. Some types are more sensitive to specific ingredients that might be in the salve, or there may be an allergic reaction. People with allergies should also check the label before using a salve for the first time. Furthermore, those with sensitive skin types should consult their physician before trying a CBD salve.

Last, whenever using a product for the first time, it’s essential to use only a small amount and test it on a small part of the body. If there is irritation or a rash, stop using the product immediately.

Is CBD Salve Right for You And Your Pain?

CBD Salve is ideal for short-term localized pain. It’s perfect for aching muscles from over-exertion or the joint pain associated with arthritis. Salves usually contain various other herbal remedies that have been proven to have therapeutic healing properties.

Many people prefer not to treat pain with pain relievers such as aspirin or ibuprofen and consider all-natural products to be better alternatives.

For anyone suffering from chronic pain or pain throughout the body, it’s always best to consult a physician as it may be a sign of a more severe condition. Furthermore, most instruction labels will state not to use CBD Salves on any open wounds or cuts.

The Bottom Line

People have been hearing a lot about CBD over the last few years. Research is still in the early stages, but scientists are excited about all the potential ways that CBD can benefit humans. CBD companies are working hard to find new ways for people to add CBD to their lives.

While CBD tinctures and edibles are a great way to achieve overall wellness, many people are discovering that CBD salves, lotions, and creams are the ideal solution for treating specific body parts with CBD.

CBD Salves are the perfect solution for providing quick relief from pain and can be re-applied several times throughout the day to stay pain-free. Essential oils enhance the effects of the CBD for added comfort.

There are many options to choose from when shopping for CBD salves. It’s important to note that the FDA doesn’t provide regulation on the safety or effectiveness of CBD products. Therefore, customers need to educate themselves on what to look for before purchasing any CBD Salves.

Last, this article is for informational purposes and instructs consumers on choosing the best, high-quality CBD salve. It’s always important to discuss any changes in medical conditions with a health provider.

AC_LatinoCovid by Allison Christensen for 360 Magazine

Antibody Cocktail May Prevent Symptomatic COVID-19 Infections

An antibody cocktail being tested at UVA Health and other sites was able to block 100% of symptomatic COVID-19 infections among people exposed to the virus, early results from the clinical trial suggest.

In addition, those who developed asymptomatic infections accumulated far less virus in their bodies than usual and saw their infections resolve within a week, according to interim data released by the cocktail’s manufacturer, Regeneron Pharmaceuticals.

“This is the first treatment shown to prevent COVID-19 after a known exposure, and offers protection for unvaccinated individuals caring for a family member with COVID-19,” said UVA Health’s William Petri Jr., MD, PhD, one of the leaders of the trial at UVA. “We expect that Regeneron will file for Emergency Use Authorization from the FDA so that this drug can be used outside of the context of a clinical trial.”

Antibodies for COVID-19

The phase 3 clinical trial aims to determine if the antibodies will prevent COVID-19 infection in people who have been exposed but not yet developed the disease. This is known as “passive immunization.”

Regeneron’s new analysis, which has not yet been published in a scientific journal, looked at outcomes in approximately 400 trial participants. Of 186 people who received the antibodies, none developed symptomatic COVID-19. Of the 223 who received a placebo, eight developed symptomatic COVID-19, the company reports.

Asymptomatic infections occurred in 15 of the antibody recipients and in 23 of the placebo recipients. Overall rates of infection, including both symptomatic and asymptomatic infections, were approximately 50% lower in the antibody group.

Among those who developed infections, placebo recipients had, on average, a peak viral load (the amount of virus in the body) that was more than 100 times greater than antibody recipients. The antibody group also recovered more quickly–all the infections resolved within seven days, while 40 percent of infections in the placebo group lasted three to four weeks, Regeneron said.

The cocktail also appears to shorten the duration of viral shedding, the time when the virus is being manufactured in the body. The viral shedding period was nine weeks among antibody recipients and 44 weeks among the placebo recipients. While people with COVID-19 are not infectious for this entire time, reducing the duration of viral shedding may shorten the period when they can spread the disease.

There were more adverse events reported among placebo recipients than among antibody recipients – 18 percent and 12 percent, respectively. Regeneron attributed this to the larger number of COVID-19 infections in the placebo group.

There was one death and one COVID-19-related hospitalization in the placebo group and none in the antibody group. Injection-site reactions were reported among 2 percent of both groups.

“We are profoundly grateful to the nurses and staff of the UVA COVID-19 clinic, led by Dr. Debbie-Anne Shirley,” Petri said. “Their day-to-day support made our participation in this trial possible.”

About the Clinical Trial

Phase 3 clinical trials, such as the one under way at UVA, examine the safety and effectiveness of new drugs and treatments in large numbers of people. Positive results in the phase 3 trial could spur the federal Food and Drug Administration to make the antibody cocktail available for post-exposure COVID-19 prevention.

The antibody cocktail is not a vaccine and is not expected to provide permanent immunity to COVID-19.

The team conducting the study at UVA is led by Petri and Shirley and includes Gregory Madden, MD; Chelsea Marie, PhD; Jennifer Sasson, MD; Jae Shin, MD; Cirle Warren, MD; Clinical Research Coordinator Igor Shumilin; assistant Rebecca Carpenter; and COVID-19 Clinic nurses Michelle Sutton, Elizabeth Brooks, Danielle Donigan, Cynthia Edwards, Jennifer Pinnata, Samantha Simmons and Rebecca Wade.

To keep up with the latest medical research news from UVA, subscribe to the Making of Medicine blog.

Pfizer coronavirus vaccination article illustration by Kaelen Felix for 360 Magazine

Pfizer × BioNTech near historic vaccine

By Althea Champion

Pfizer and BioNTech announced on Monday that their COVID-19 vaccine is more than 90 percent effective. If approved, it could potentially be available to the public by early December, according to Dr. Anthony Fauci.

The results came out of Pfizer’s Phase 3 trial, which involved 40,000 individuals. Of those participating, 94 contracted COVID-19. These results, like much of 2020, are historic. Vaccines have never been developed on such a fast-moving timeline. The last vaccine that was developed in such considerable haste was for mumps, and it took four years.

Pfizer says that they plan to ask the Federal Drug Administration for emergency use by the end of the month. The vaccine will require two doses administered three weeks apart. The company hopes to have enough doses for 25 million people by the end of the year, and 650 million people in 2021.

In the case that the vaccine supply is limited, the C.D.C. will first vaccinate healthcare personnel, essential workers, people who are at high risk for severe COVID-19 illness due to underlying medical conditions, as well as those 65 years and older.

An expedited timeline does not mean drug companies are cutting corners. Fauci, like many of his colleagues in Washington, assures that manufacturers will stick to a process of vaccine development that ensures the safety of patients. The FDA will still make the final call.

“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in Pfizer’s press release. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

However, a few questions remain unanswered.

“Historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions,” writes Arthur Allen in the Opinion section of the NYT. “Not through company press releases.”

According to Allen, it is unclear from the press release how long Pfizer’s vaccine will keep patients protected, if it is safe for high-risk populations like the elderly, or if rare side effects can arise in patients who are vaccinated. He notes that the Novavax and Sanofi Pasteur vaccines may be safer for older patients.

Novavax and Sanofi Pasteur are subunit vaccines, like the hepatitis B vaccine. They deliver only the essential antigens of the virus to the immune system, so it learns how to attack it. Because it is only a part, or a subunit, of the virus, fewer side effects are likely.

Pfizer’s is a nucleic acid vaccine that uses RNA. According to the Washington Post, “this type of vaccine contains a strip of genetic material within a fat bubble” that enters the cell. Once inside, “the RNA generates a protein found on the surface of the virus.” It can then familiarize itself with the virus and learn how to fight it.

Moderna’s vaccine is also an RNA vaccine in Phase 3 trials. Pfizer’s success bodes very well for Moderna, according to a statement Fauci made to CNN.

Furthermore, because the vaccine must be stored in extremely low temperatures—on dry ice at negative 100 degrees Fahrenheit according to the Washington Post—its roll-out becomes complicated. If left out in the sun, or just at room temperature, or even at just below freezing, the mRNA self-destructs and the vaccine becomes useless.

Shortly after Pfizer’s announcement, President-elect Joe Biden addressed the nation, warned of the “dark winter” ahead, and urged Americans, regardless of party affiliation, to wear a mask until the vaccine is available.

The head of the C.D.C. warned this fall, that “for the foreseeable future, a mask remains the most potent weapon against the virus,” he said from the podium. “Today’s news does not change that urgent reality.”

Elyptol Sanitizers Clean × Heal

Elyptol is the first Type 1 eco-certified and professionally registered hand sanitizer. It harnesses the healing properties of eucalyptus oil and naturally-sourced pure ethanol to bring you a product that sanitizes in a healthy and eco-friendly way. Despite its gentle feel, make no mistake that this hand sanitizer is FDA listed and hospital grade.

To Kill Germs Gently, Think Naturally with Elyptol

The sanitizer kills 99.99997% of germs with 70% alcohol. It contains eucalyptus oil and pure ethanol derived from sugar cane to eliminate germs gently and safely. And, it uses botanical food grade ethanol and eucalyptus ingredients that are known for soothing and healing aching bones and irritated skin.

Not only is Elyptol antibacterial, but it is antimicrobial as well. For this reason, it kills a wider range of germs.

“The perfect synergy of science and nature,” notes the company on their front page. “Elyptol harnesses nature’s strengths to create skincare and hard surface hygiene products that effectively kill germs harmful to your health.”

About Elyptol:

The USA/Australian company takes its natural inspiration from those putting their lives on the line for us every day. Elyptol founder Tim O’Connor recognized just how much health care workers used sanitizers when his daughter was born. These hospital grade formulas wreaked havoc on their hands. With years of extensive research and development using green chemistry, Elyptol became the first Type 1 eco-certified and professionally registered hand sanitizer. It expertly pairs eucalyptus oil, known for its healing properties, and natural sanitizing ingredient pure ethanol, derived from sugarcane and corn. The result is an efficient formula that eliminates germs, yet it’s gentle enough on skin and safe for the environment.

Vape pen and e-cigarette shot by Vaughn Lowery for 360 MAGAZINE

Do You Vape? How to Prepare for the Upcoming PMTA Deadline

Do you vape? If you do, there’s an important deadline coming up on September 9 – and if you haven’t already started preparing, now is the time. 

Are you left scratching your head after reading that first paragraph? If you have no idea what deadline is coming up or how it’s going to affect the vaping industry, this article is for you. We’re going to explain the upcoming PMTA deadline and describe exactly what you should be doing right now to prepare.

FDA Vaping Regulations: A Brief History

Ever since e-cigarettes and e-liquids first appeared in the United States, the FDA has attempted to exert regulatory control over the industry. The agency’s first attempt at vaping regulations ended in failure. In the late 2000s, the FDA began to seize incoming shipments of e-cigarettes entering the United States, saying that vaping products were unregulated drug delivery devices being sold without approval.

The vaping industry sued the FDA. The district and appeals courts involved in the lawsuit both ultimately decided in favor of the vaping industry, ruling that, as long as sellers didn’t claim that e-cigarettes could be used for quitting smoking, the FDA could only regulate those products as tobacco products – not as drug delivery devices.

The FDA finally announced its intention to regulate vaping products as tobacco products in 2016. Subjecting vaping products to the same legal requirements as tobacco products meant that every vaping product on the market had to comply with the U.S. Family Smoking Prevention and Tobacco Control Act, which said that, after 2007, all tobacco products must obtain FDA approval before entering the market.

No vaping product being sold today was on the market before 2007. Therefore, every vaping product is a “new tobacco product” that requires FDA approval.

What Is the Vaping PMTA Deadline?

We always knew that this day would come; it was just a matter of when. The vaping industry’s deadline for FDA compliance has been moved from August 2018 to August 2022 before being moved forward to May 2020 and finally pushed back to September 2020. At the time of writing, it appears that September 9, 2020 will be the final compliance date.

To start the process of FDA compliance, the manufacturer of a vaping product must submit an application showing the FDA that the product is beneficial to public health compared to the tobacco products that are already on the market. It costs nothing to file a premarket tobacco product application (PMTA), but the cost of gathering the required data for the application can exceed $100,000. Every e-liquid flavor, every nicotine strength of every flavor, every vaping device, every tank and every coil counts as a “new tobacco product” and requires a PMTA.

What Happens to the Vaping Industry on September 9?

When the PMTA deadline arrives, two things will happen.

  • Many e-liquid makers have the necessary funds to submit PMTAs for some or all of their products. Timely submission of a PMTA means that a product can remain on the market for another year while the FDA processes the application. If the FDA gets behind on processing applications, it’s possible that the grace period will be extended.
  • Many other e-liquid makers do not have the funds and are not planning to submit PMTAs. Those companies are required to pull their products from the market on September 9, although that may not happen all at once. Some companies may just continue what they’re doing now until they hear from the FDA.

What Does the PMTA Deadline Mean for Vapers?

The one certain thing is that, after September 9, there will be fewer vaping devices, tanks, coils and e-liquids on the market than there are today. Since most companies in the vaping industry aren’t talking about their plans for the PMTA deadline, it’s impossible to say exactly which products will and won’t be available. With that in mind, here’s how you need to prepare.

Stock Up on Your Favorite Vape Juice Flavors Now

Unless your favorite vape juice brands have already announced that they’re ready for the PMTA deadline, you shouldn’t assume that those brands’ products will still be around after September 9. There will definitely still be e-liquid available to buy after the PMTA deadline – but if you have a favorite brand or flavor and can’t bear to be without it, you should start stocking up right now.

Get a Vape Mod With Removable Batteries

It’s unknown which of the vaping hardware manufacturers – almost all of which are in China – have submitted PMTAs for their products or which products they’ve applied for permission to continue selling in the United States. Your best bet is to choose a vape mod with removable batteries and buy it right away. A mod with removable batteries can conceivably last for years because you can simply swap out the batteries when they stop working correctly. A mod with a permanent battery, on the other hand, is much more difficult to repair. The FDA doesn’t regulate batteries, so you can buy them freely.

Buy a Rebuildable Atomizer

It’s also unknown which vape tanks and coils will get through the PMTA process. If you have a favorite vape tank and want to ensure that you can continue using it, you should stock up on coils now. In the long run, though, it’s even better to grab a rebuildable atomizer and learn how to build your own coils. The FDA can regulate tanks and coils, but it can’t regulate wire and cotton – just like it can’t regulate batteries. Regardless of how FDA regulation shapes the future of the American vaping industry, you won’t ever have trouble finding coil building supplies.

Consider Learning How to Make Your Own E-Liquid

As mentioned above, you will definitely still be able to buy e-liquid after September 9. Many e-liquid companies have already submitted – or are about to submit – PMTAs for their products. They’ll be able to continue selling their products for at least another year, and it seems likely that many or all of those products will eventually receive full FDA approval.

Just in case those products don’t receive FDA approval, though, it’s a good idea to start learning how to make your own e-liquid now. You’re free to buy vegetable glycerin, propylene glycol and flavorings. Unless something changes from a legal standpoint, you’re also free to buy liquid nicotine if you’re an adult. As of right now, there’s nothing preventing you from making your own vape juice.

New approach to airborne disinfection uses food-coloring dyes

Purdue – Airborne Disinfection

By Chris Adam

The COVID-19 pandemic has shed new light on the needs for improved disinfection methods, both for individuals and facilities.

Purdue University innovators have developed an airborne disinfection method – using food-coloring dyes – to be applied to the entire body and rooms for sterilization purposes and lowering the risk of infection.

The Purdue team’s disinfection method uses edible materials. The Purdue team presented the technology in July during a COVID-19 virtual conference sponsored by the National Council of Entrepreneurial Tech Transfer.

“Most of the antiviral and antibacterial sprays used for airborne antiviral and antibacterial disinfectants, such as aerosolized hydrogen peroxide, ozone, and deep ultraviolet illumination, are a biohazard risk to humans,” said Young Kim, an associate professor of biomedical engineering at Purdue. “Additionally, disinfectants containing titanium dioxide and noble metal nanoparticles pose carcinogenic and cytotoxicity risks.”

Kim also said new methods are needed since transmission of pathogens (viruses and bacteria) often occurs in the air and infection with pathogens is transmitted by an airborne route. The Purdue method might also help in medical settings, where healthcare workers typically are exposed to the disease-causing agents when they take off their personal protective equipment.

The Purdue airborne antiviral phototherapy technique uses small aerosols FDA-approved food coloring dyes to mitigate the risks of airborne transmissions of pathogens. This is referred to as Photodynamic Airborne Cleaner (PAC).

“We have demonstrated with our novel solution how visible light activation of several FDA-approved food coloring dyes generate singlet oxygen, which can be used to kill airborne pathogens,” Kim said. “In the medical community, it is well known that singlet oxygen is effective to inactivate viruses. We are developing a scalable aerosol generation system for the dyes, allowing uniform fog-like dispersion lingering in the air to minimize wetting and surface staining. In addition, as health care workers are often infected when removing PPE, this technology can be installed in a confined chamber for health care professionals to change PPE in hospital settings.”

The novel photoreactive arrangement can be used in rooms where many people are present at risk of airborne pathogen exposure.

The innovators are working with the Purdue Research Foundation Office of Technology Commercialization to license this patented technology.

The researchers are looking for partners to continue developing their technology. For more information on licensing and other opportunities, contact D.H.R. Sarma of OTC at DHRSarma@prf.org and mention track code 2020-KIM-69064.

Kim also is receiving support from Purdue’s Trask Innovation Fund, which helps labs commercialize their innovations.

About Purdue Research Foundation Office of Technology Commercialization

The Purdue Research Foundation Office of Technology Commercialization operates one of the most comprehensive technology transfer programs among leading research universities in the U.S. Services provided by this office support the economic development initiatives of Purdue University and benefit the university’s academic activities through commercializing, licensing and protecting Purdue intellectual property. The office recently moved into the Convergence Center for Innovation and Collaboration in Discovery Park District, adjacent to the Purdue campus. In fiscal year 2020, the office reported 148 deals finalized with 225 technologies signed, 408 disclosures received and 180 issued U.S. patents. The office is managed by the Purdue Research Foundation, which received the 2019 Innovation and Economic Prosperity Universities Award for Place from the Association of Public and Land-grant Universities. In 2020, IPWatchdog Institute ranked Purdue third nationally in startup creation and in the top 20 for patents. The Purdue Research Foundation is a private, nonprofit foundation created to advance the mission of Purdue University. Contact otcip@prf.org for more information.

About Purdue University

Purdue University is a top public research institution developing practical solutions to today’s toughest challenges. Ranked the No. 6 Most Innovative University in the United States by U.S. News & World Report, Purdue delivers world-changing research and out-of-this-world discovery. Committed to hands-on and online, real-world learning, Purdue offers a transformative education to all. Committed to affordability and accessibility, Purdue has frozen tuition and most fees at 2012-13 levels, enabling more students than ever to graduate debt-free. See how Purdue never stops in the persistent pursuit of the next giant leap at purdue.edu.

Coronavirus Vaccine – Dr. Jeremy M. Levin

A story in USA Today this morning asks whether a coronavirus vaccine could repair the pharma industry’s reputation despite drug price increases. Dr. Jeremy M. Levin, an iconic biotech thought-leader who first introduced immuno oncology to the world 10 years ago, is quoted:

“The pandemic ‘has driven the public eye onto what the biotech industry does, which is change the dynamic of a disease,’ said Jeremy Levin, chairman of BIO and author of the recently published book Biotechnology in the Time of COVID-19: Commentaries from the Front Line. “In the noise that came from the bad actors, we basically lost sight of the essence of what the biotech is all about, which is patients and innovation.”

Here are some additional thoughts from Dr. Levin’s on developing a vaccine and the road forward:

What can you (and the biotech industry) tell the American people that they haven’t already heard? Unless we are able to get a handle on COVID-19, we as a society as a whole are at great risk. There has never been a greater risk from a transmissible disease to our nation, and the world at large.

There is incredible pressure to expedite a COVID-19 vaccine, even if it hasn’t been tested in the way it needs to be tested.

What are the risks/rewards? The risks of rushing a vaccine are  considerable, and the FDA will be acutely aware of this when making an approval. I expect there will be extraordinary diligence from the FDA, as well as from each company producing a vaccine. Despite this, the risk of not developing a vaccine are nearly unimaginable.

How long is the typical timeline for vaccine development? A typical timeline for vaccine development is at least a decade, but many variables go into this. This article in the NY Times is a useful explainer.

Dr. Levin is available for interviews on COVID-19 and other biotech topics. He is currently CEO and Chairman of OVID Therapeutics, Inc., and Chair of the global Biotechnology Innovation Organization (BIO). In 2018 Dr. Levin was named “one of the most influential figures in biopharmaceutical industry” by FierceBiotech, and one of the top three biotechnology CEOs in 2020 by The Healthcare Technology Report. See him interviewed HERE on CNBC.

FDA Accelerates E-Cigarette Review For New Rules

By Eric Van Buskirk

Suorin Air Starter Kit

In 2016, the Food and Drug Administration was expanded to regulate tobacco as well as nicotine products, including cigars and e-cigarettes. A year later, the FDA issued an ultimatum to manufacturers: provide sufficient information to justify the continued circulation of your tobacco and nicotine products on the market, and do so by May 2022.

The deadline was initially set in order to provide manufacturers ample time to produce studies and research against the charge that their products were both aimed at and increasingly consumed by American teenagers. However, the American Academy of Pediatrics (AAP) and their partners — responsible in large part for pressuring the FDA into action — immediately challenged the timeline, positing that such a long waiting period was unacceptable.

AAP President and Fellow of the American Academy of Pediatrics Kyle E. Yasuda, M.D. was quoted as saying, “the FDA oversight over the sales and marketing of these harmful products has languished for too long. With the epidemic of e-cigarette use by teens, it is incumbent on the FDA to act expeditiously to hold manufacturers accountable for products that contain nicotine and harmful chemicals.”

In March 2018, the AAP as well as the American Cancer Society, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five pediatricians sued the FDA, Department of Health and Human Services (HHS) and the heads of both agencies. According to the suit, the coalition intended to take action against the FDA and HHS not only for their decision to provide manufacturers with such a generous grace period, but for allowing them to continue selling their products until the scheduled date of review.

Finally, in May this year, U.S. District Judge Paul W. Grimm of Maryland ruled in favor of the AAP and its partners, aiming pointed statements at the FDA in the process. “Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved — results entirely contrary to the express purpose of the Tobacco Control Act,” he wrote.

Companies and manufacturers now have ten months before the FDA is set to begin their review in May 2020. Grimm’s remarks are worth exploring in detail, as there is recent data that bears out his point. A study by the Centers for Disease Control and Prevention (CDC) shows that vaping rates among high schoolers and middle schoolers increased by 78% and 48% respectively over 2017 — just one year of the six-year grace period originally afforded to cigar and e-cigarette manufacturers by the FDA.

An Accelerated Review & Its Impact on E-Cigarette Manufacturers

For e-cigarette giant Juul and tobacco juggernauts Philip Morris International, Imperial Brands and Altria, the next ten months will be a battle to continue selling their Juul e-cig and iQOS systems — but it’s a battle they’re confident they can win. Other manufacturers like Sourin Air, who really more on online sales, are a bit less concerned about sales since online purchases have getter systems in place to prevent under-age buying.

“We are secure in the content and quality of our application for May,” stated Juul spokesperson Ted Kwong in an interview with Forbes. “Our growing body of evidence as well as our industry-leading actions to combat underage access and use will ensure adult smokers continue to have a true alternative to cigarettes, the leading cause of preventable death worldwide.”

Representatives from the so-called “tobacco Big Five” expressed similar convictions.

For smaller companies and e-cigarette manufacturers, the FDA’s accelerated review represents an entirely different struggle. Until 2016, the vaping industry as a whole had gone largely unregulated, and products were able to enter the market without needing FDA approval. The processes of preparing applications, litigating their cases and abiding the coming surge of new regulations is very likely to decimate the profitability of smaller e-cigarette operations. For them, the next ten months will be a struggle for their continued existence.

Ironically, it may very well be the case that Juul — which is estimated to control three fourths of the e-cigarette market — and the tobacco Big Five will come away the biggest winners by the end the FDA’s accelerated review.

Toilet Seat Detects Congestive Heart Failure

Toilet seat that detects congestive heart failure getting ready to begin commercialization

Researchers developed the seats to measure biometrics during ‘natural’ processes

With 1 million new cases of congestive heart failure diagnosed each year, a revolutionary product is making it easier for hospitals to monitor patients with the condition in the comfort of their own homes.

A toilet-seat based cardiovascular monitoring system created by a team of Rochester Institute of Technology researchers, aims to lower the hospital readmission rates of patients with congestive heart failure. The toilet seats, which will be brought through the FDA clearance process by the researchers’ company Heart Health Intelligence, would be purchased by hospitals and issued to heart failure patients after discharge. The toilet seats are equipped to measure the electrical and mechanical activity of the heart, and can monitor heart rate, blood pressure, blood oxygenation levels, and the patient’s weight and stroke volume, which is the amount of blood pumped out of the heart at every beat. Algorithms analyze the data, and with further development, will alert advanced practice providers of a deteriorating condition. A report will be passed along to cardiologists who will then determine if intervention is necessary.

Nicholas Conn, a postdoctoral fellow at RIT and founder and CEO of Heart Health Intelligence, is part of the university team that developed the toilet seats.

“Typically, within 30 days of hospital discharge, 25 percent of patients with congestive heart failure are readmitted,” said Conn. “After 90 days of hospital discharge, 45 percent of patients are readmitted. And the Centers for Medicare and Medicaid Services is penalizing hospitals for readmitting patients for heart failure.”

Conn, the company’s chief executive officer, further explains that using the national average for readmission rates, the penalty alone for readmitting 150 patients is approximately $500,000 annually. The total cost of providing 150 patients with their own monitored toilet seats from HHI is $200,000. With that investment, he says, hospital systems will save more than double their initial investment within one year.

According to Conn, who earned three degrees from RIT—a bachelor’s degree and a master’s degree in electrical engineering in 2011 and 2013, respectively, and a doctoral degree in microsystems engineering in 2016—the system will pick up deteriorating conditions before the patients even realize they are symptomatic. And with the rapid data analysis, interventions can be as simple as a drug change or short office visit, instead of an admission to the hospital.

HHI, which joined RIT’s Venture Creations business incubator earlier this year, is now focused on moving the product forward. The team is heavily involved in writing grants for additional funding and networking, and human-subject testing and pre-clinical studies are well underway. Conn and his team are working on approving the product with the FDA and rolling it out across the country.

To read more about the research behind the project, go to here.

For more information, contact Vienna McGrain at 585-475-4952 or Vienna.Carvalho@rit.edu.

About Rochester Institute of Technology

Rochester Institute of Technology is home to leading creators, entrepreneurs, innovators and researchers. Founded in 1829, RIT enrolls about 19,000 students in more than 200 career-oriented and professional programs, making it among the largest private universities in the U.S.

The university is internationally recognized and ranked for academic leadership in business, computing, engineering, imaging science, liberal arts, sustainability, and fine and applied arts. RIT also offers unparalleled support services for deaf and hard-of-hearing students. The cooperative education program is one of the oldest and largest in the nation. Global partnerships include campuses in China, Croatia, Dubai and Kosovo. To follow RIT on social media, go to www.rit.edu/socialmedia.

CartiHeal

Seth L. Sherman, MD, a sports medicine orthopaedic surgeon at University of Missouri Health Care’s Missouri Orthopaedic Institute, recently became one of the first American surgeons to enroll patients in a clinical research study aimed at earning FDA approval for a new knee-cartilage implant.

Agili-C™ (CartiHeal, Israel) is a new implant designed to help patients with knee-cartilage defects regenerate their own healthy cartilage. The implant has been shown to be safe and effective in a series of clinical trials previously conducted in Europe and Israel. Sherman is one of 15 primary investigators in the United States conducting the FDA-approved study, which is the final step before earning FDA approval for the implant.

“We are thrilled to be on the leading edge of orthopaedic sports medicine and joint preservation,” Sherman said. “In the U.S., there are limited options for off-the-shelf cartilage repair that can be performed during a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, and strong basic science and clinical track record.”

Cartilage damage is a common knee problem that occurs in patients of all ages. It can happen as a result of an injury, like a blow to the knee, or due to wear and tear over time. In any case, it causes knee swelling, stiffness and pain that can reduce function and decrease quality of life.

The Agili-C™ implant is a cell-free implant made of the inorganic exoskeleton of sea coral. The implant can be used in this study to treat a variety of cartilage defects and patient types, which is another reason it is attractive to orthopaedic surgeons.

“Often in studies like this one, we can enroll only a very strict subset of young, active patients with a single, isolated cartilage defect,” said Sherman. “In reality, that’s not the type of patient we see every day. This implant is different because it’s medically indicated for a wide range of situations, including patients with multiple cartilage defects and even those with mild to moderate osteoarthritis. We can use it in patients who are in their 20s or in those who are in their 60s. This versatility allows us to find more patients who may benefit from this procedure.”

Those who qualify for the study are randomly assigned either one of the traditional surgical options or the new implant. So far, Sherman has enrolled four patients in the study. He plans to enroll at least 25 before submitting his research to the FDA.

The implant is manufactured by CartiHeal, a medical device company headquartered in Kfar Saba, Isreal and Closter, New Jersey. To date, more than 400 patients in Europe and Israel — where the device has already been approved — have received the new implant. The Agili-CTM implant is not available for sale in the United States. It is an investigational device limited for use in the device study.

To find out if you qualify for this study, visit this link on the CartiHeal website.