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Reynolds American Seeks FDA Review for Vuse

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Reynolds American Inc. filed for a review with the FDA for a review of Vuse, an e-cigarette manufactured by the company. The main rival for Vuse is Juul Labs Inc. which has the leading share of the market. However, this review application could give the company an edge over Juul.

Challenges for the Vaping Industry

The US Food and Drug Administration had set a deadline for May 2020 for manufacturers of e-cigarettes and vaping devices to submit a formal application. The application is a request to keep the products on the market while preventing the use of e-cigarettes by those who are underage.

The Vuse e-cigarette provides nicotine to users through a vapor system with cartridges. Reynolds provided the FDA with the detailed design and manufacturing process as well as data on safety of the product. It resulted in more than 150,000 pages of documents.

E-cigarette manufacturers are required to submit these applications for a review if they want to keep their products on the market. The agency is attempting to figure out the best way to monitor the manufacturing as well as the marketing of the products.

The changes come as a result of the outbreak of a lung illness that has been linked to vaping. At least 29 people have died and another 1300 have contracted the disease. It has also been an issue with the rise of teen vaping as manufacturers appear to be marketing to this segment even though they cannot legally purchase the product.

Taking Action to Protect the Public

Companies like Juul Labs have suffered because of the illness, which has not only affected adults but those who are under the age of 18. One person under that age has died from the illness. Critics have said that Juul marketed to teens by creating ads that would appeal to that age range and by using flavors which are geared towards that segment of the market, such as bubble gum and fruit flavors.

The federal government has developed a plan to remove all flavored e-cigarettes from stores, including those with menthol. Allegations abound that e-cigarette use leads to nicotine addiction and can even cause addiction to other substances. While the manufacturers say that the products were designed as an alternative to tobacco for smokers, many non-smokers have began vaping. Some studies indicate that the nicotine in the products could lead to addiction.

Another concern is that people are buying the vaping products off the street or adding their own chemicals instead of using what is included with the product. THC, an active ingredient in marijuana, is in many of the devices. It is also being linked with a majority of the illnesses. While investigators cannot say for certain that the substance is the cause of the lung disease, they do warn people to be cautious when vaping. In fact, they recommend not vaping at all until an exact cause can be determined.

With Reynolds submitting a formal application, it places them in a good position to increase their share of the market with Vuse over Juul.

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eBay to Remove Reclined Sleepers from Website

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Consumer Reports asks retailers to stop selling inclined sleepers, citing them as dangerous for infants. This request is for online marketplaces as well, and eBay is complying.

eBay will be banning all inclined infant sleepers from the website, not just those that have recall notices attached to them. This action is in response to a letter sent from Consumer Reports to 15 businesses in the retail industry, including eBay.

Dangerous for Babies

Inclined sleepers for infants angle babies between 10 and 30 degrees, which can be dangerous for them when they fall asleep. Consumer Reports has deemed the entire category or infant reclined sleepers as unsafe because of the overall design. Products in this category have been linked to 73 infant fatalities.

These products are dangerous because they put the babies at an incline for sleeping. The infant’s head can lean forward, putting their chin down on their chest, which can compress the airway and allow them to suffocate. Other issues with these products include soft bedding and having a rounded surface which isn’t in following of the recommendations from the American Academy of Pediatrics (AAP).

eBay has already started enforcing the restrictions and banning products, such as the Hiccapop DayDreamer and Evenflo Pillo Portable Napper. The Fisher-Price Rock ‘n Play Sleeper is one of the best known and was recalled earlier in the year. In fact, over five million products in this category have been recalled. Several brands are still available to purchase even though experts have warned against using them.

Multiple organizations have advised parents, daycare centers and others not to use any infant inclined sleeper, including the AAP and Consumer Federation of America.

The companies contacted in the letter include:

  • Amazon
  • Bed Bath and Beyond
  • Albee Baby
  • Craigslist
  • Buy Buy Baby
  • Facebook
  • Macy’s
  • Kohl’s
  • Target
  • Walmart
  • Magic Beans
  • You Are My Everything

Both eBay and You Are My Everything have agreed to remove the products from sale. Other companies have not replied to the letter. One of the concerns with these products is they are marketed as safe for resting or napping, but it only takes a few minutes for a baby to suffocate when they fall asleep. Experts say it’s wrong to promote them as safe for any amount of sleep. Babies have suffocated in infant reclined sleepers in less than 15 minutes, according to incident reports.

Along with the risk of suffocation, another danger is with the baby being able to roll over. They roll from their back to their stomach if they are left unrestrained, which is another position which increases the risk of suffocation. They may turn into the side of the device and smother.

The AAP recommends putting babies to bed on a firm mattress with no other bedding. They should be placed on their backs with nothing else in the bed. This is the only position which is approved by the AAP and for doctors until the baby is able to turn over by themselves.

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New Tests for Johnson & Johnson Baby Powder Show No Asbestos

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According to Johnson & Johnson, new tests on Johnson’s Baby Powder show that the product is free of asbestos. Trace amounts had been found previously, as reported by the US Food and Drug Administration (FDA).

Testing for Asbestos

A test conducted by the FDA earlier had shown indications of asbestos being present in the powder. In response, the manufacturer recalled a single lot of the baby powder back in October. Since then, Johnson & Johnson has conducted 155 tests using two third-party labs and four testing methods. The samples were from the same bottle used in the FDA tests.

The manufacturer had already responded to the FDA findings by conducting a small test in October which showed no asbestos findings. However, the DFA stood by its results. Officials did say that the difference in tests could be the result of contaminants not being uniform in the product. They also admitted there is no standardized testing to detect asbestos in talc.

The tests that were done by the third-party labs showed no asbestos in the bottle or in any samples of the rest of the lot from which the bottle came. The manufacturer suggested that the FDA results were from contamination or a lab error.

About 33,000 bottles of the product were recalled in the US in October after the FDA results were noted. This was a voluntary recall by Johnson & Johnson and the first time for such a recall. However, it’s not the first time the company has faced accusations that the products cause health issues, including cancer.

Mesothelioma

Asbestos is a known carcinogen, which means it’s likely to cause cancer. In this case, it is mesothelioma, which is a deadly type of cancer that acts fast and is aggressive.

Mesothelioma results from the asbestos fibers getting into the lungs. Over time, continued exposure to asbestos causes the fibers to build up in the lungs. Mesothelioma is a cancer of the lining around the lungs or abdomen as well as other organs.

This is a rare type of cancer that has fewer than 20,000 new cases diagnosed each year. Treatments are available, but they only manage the condition rather than curing it. A person can live for several years with mesothelioma while some have had much longer lifespans after the diagnosis.

Common symptoms of mesothelioma include coughing and pain in the chest. The person may be short of breath and often loses weight. Several options for treatment exist, but the cancer metastasizes quickly. Chemotherapy may be an option as well as radiation. Surgery and other medical procedures may be recommended, but they only help with the condition rather than removing the cancer.

When mesothelioma is caused by exposure to asbestos, it happens over a longer period. Products that contain the material can release it into the environment where the person will inhale it. Slowly, enough of the asbestos will accumulate in the lungs to cause a problem. Because of it being a carcinogen, asbestos is banned from products in the US.

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Vapers May Pay Higher Life Insurance Premiums

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Reinsurers around the world are reevaluating insurance premiums and risk for those who vape. Vapers may end up paying more for insurance than smokers or even be excluded completely from some policies.

Current totals for vaping deaths stand at 47 for one mysterious lung illness that has been connected to vaping. Other health concerns have continued to grow even though some studies show that vaporizers and e-cigarettes help smokers to stop using traditional cigarettes.

Warnings to Insurers

Reinsurers are the companies that insure the insurance providers. They use their vast research tools to help insurers determine risk. While they don’t provide recommendations for pricing or require specific policies, they do give general advice on risk. They can also charge higher premiums or even fail to provide reinsurance if their advice isn’t followed.

In the past, vapers were treated like smokers when it came to insurance. Smokers already pay up to twice as much as nonsmokers for life insurance because of the higher risk for lung cancer and other health problems. Three reinsurers have updated their recommendations on vaping recently with others still considering their guidelines.

The warnings from the reinsurers includes vaping products that contain THC, which is an active ingredient in marijuana. They also focus on younger vapers, particularly insuring those who are under the age of 25 due to the recent illnesses and deaths from the vaping illness. Many of those who have had the illness have been under that age and even still in their teens.

Many insurers are treating vapers the same as smokers while refusing to insure those who are vaping products which may be likely to cause cancer. Supporters of vaping believe this step is harsh because it’s already difficult for people who smoke to get insurance.

Most insurers have already put vapers with smokers when it comes to pricing and risk. The few that didn’t in the past are beginning to change their stance now. Reinsurers are continuing to monitor the information available about vaping and health concerns.

Damage from Vaping

It’s still too early to tell the long-term damage from vaping. If more illnesses from vaping become apparent, it is expected that insurers will respond accordingly. The US Centers for Disease Control and Prevention have recommended that people stop vaping, especially with products that contain THC or vitamin E. Experts suggest that people give up vaping completely until it’s determined what ingredient is causing the epidemic that overtook the nation during the summer.

This is another hit for vaping manufacturers who have already lost customers and support due to the negative publicity and information being presented. They continue to claim that vaping is safer than smoking, but recent deaths have placed a high concern about this idea out to the public. In fact, JUUL was one manufacturer that the FDA gave a warning to for promoting their products as a safer alternative. That claim cannot be made unless specific data is provided to support it, which JUUL did not have. The manufacturer has stopped all marketing in the US but still continues to promote products in other countries.

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