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Vaping Concerns are Global

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After the mysterious illness tied to vaping gained notoriety during the summer of 2019, states took action to curb the manufacture and purchase of vaping products which most appealed to minors. Agencies also advocated against vaping and e-cigarette use while a conclusive link between the products and the illness was sought.

While the illness has been diagnosed in almost all the states and deaths related to the illness have occurred in more than half of the states, the concerns about vaping aren’t limited to the US. Other countries have begun taking a stance on the vaping issue.

New Zealand

The government of New Zealand is planning to introduce legislation that bans any advertisements of e-cigarettes and related products to anyone under the age of 18. The goal is to regulate the market and protect teens. At the same time, the government wants to keep e-cigarettes available for smokers who want to quit.

The bill would ban vaping products, including smokeless tobacco in areas that are already smoke-free. It would provide restrictions on who can sell these products and allow the government to recall products or suspend the manufacturing.

Unlike the US, New Zealand isn’t prohibiting flavored products. However, they limit stores that sell merchandise from selling any flavors beyond, mint, menthol and tobacco.

Indonesia

JUUL Labs Inc. announced that it as stopping sales of its vaping products in Indonesia because the market is mainly unregulated. According to the manufacturer, it can’t prevent stores from selling vaping products to underage buyers.

JUUL markets its products in Indonesia, South Korea and the Philippines as it has worked to expand into the Asian market. Critics claim that the company is using similar marketing practices to what it did in the US, which led to warnings from government regulators. JUUL has said it would suspend sales in Indonesia until it could find ways to ensure age restrictions are enforced to maintain compliance.

The manufacturer first launched in Indonesia seven months ago, allegedly targeting customers in the 19-35 age range. JUUL has also delayed expansions into New Zealand and the Netherlands which were planned before the current concerns with vaping products. It is reviewing operations in other markets on an individual country basis.

Concerns About Vaping Continue

While JUUL products aren’t the primary ones involved in the vaping illness that spread around the country, the concern about the risk for vaping in general has led to increased scrutiny. JUUL has been at the forefront of the scrutiny due to allegations that the company targeted underage vapers with its product design and advertising.

Statistics show that vaping has increased among teens, and experts believe it comes from the fruity and dessert flavors of the products coupled with the unique advertising that appeals to a younger audience. JUUL has maintained that it markets to adult smokers, but many parents and schools are concerned about the number of underage vapers who are buying and using JUUL and other vaping products. Continued research is being conducted to determine the true risk of vaping.

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Bayer Settles 90% of U.S. Essure Claims for 1.6 Billion

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About 90 percent of the more than 39,000 lawsuits filed against Bayer over Essure injuries have been resolved by a $1.6 billion settlement. Bayer said in a statement that the settlement resolves most filed and unfiled cases and that it continues to work with plaintiff’s lawyers to resolve the remaining cases.

FDA Actions and Essure Injury Complaints

The settlement comes after years of complains of adverse events involving the metal coils which are placed in the fallopian tubes. Some of these complaints say that the coils can perforate the tubes, tear the uterus, and that the coils can break causing little metal shards to migrate elsewhere in the body. Women have also complained of heavy bleeding, pain, and other side effects that the patients were forced to undergo hysterectomy.

In 2018, the U.S. Food and Drug Administration placed restrictions on the device and required patients to review the Patient- Doctor Discussion Checklist and sign prior to being implanted with the birth control device. Bayer made the decision to stop selling Essure in the United States not long after citing declining sales.

Post-Market Surveillance Reports

The required 522 study, a post-marketing surveillance plan, was also extended by the FDA from three to five years. The FDA published the first spreadsheet of Essure adverse events on August 11, 2020, which includes events that Bayer knew or learns of during the period of November 2016 to November 2020.

The first spreadsheet includes more than 1,400 events including pain, device fragments, pregnancy, and organ perforations, including 1376 reports of serious injury, 53 reports of death and 24 reports of malfunction.

Essure Lawsuit Settlement

Many of the plaintiffs alleged in court filings that Bayer knew or should have known about the risk of adverse events, including organ perforation, device breakage, and device migration. They also allege that Essure birth control was improperly design and can break and migrate after being implanted. They accused Bayer of misrepresenting the efficacy and safety of the contraceptive device and Women who suffered Essure injuries alleged in court filings that Bayer concealed the risks and dangers of the device from the FDA, the medical community and from the women who relied on the device.

Many of the terms of the settlement are confidential, and Bayer did not admit to any wrongdoing in the court filings.

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Covid-19

Risk for COVID-19 Goes Up for Vapers

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A new study shows the correlation between COVID-19 and young adults who are vaping. This includes teens as well. According to the study, the risk for developing the infection was five times higher if the person vaped regularly.

The study also indicated an increase of seven times the risk for young adults who vape and smoke tobacco cigarettes. The study was published in the Journal of Adolescent Health. Because of this information, the government has asked the US Food and Drug Administration (FDA) to remove all e-cigarettes from the market until after the pandemic has been dealt with.

E-cigarettes and Damage to the Lungs

Experts are concerned about the high numbers. They want young adults and teens to be aware that e-cigarettes and vaping devices aren’t safe. They come with serious harm that is real.

The evidence isn’t astounding, but it is important. It is well-known that e-cigarettes can harm the lungs as well as the immune system. In 2019, there were numerous cases of a mysterious lung illness associated with vaping. Many people got sick from the illness after vaping, and several people died.

There is another correlation between vaping and COVID-19. According to researchers, the SARS-CoV-2 virus that causes COVID-19 needs a pathway to get into the body’s cells. It is believed that e-cigarettes might make the pathway easier to access.

Another risk is that teens and young adults often share vaping devices. If one person is positive for COVID-19, the next person using that device could become infected as they inhale the virus right into their lungs. Exhaling from the vaping device could also cause people nearby to become infected.

The government is interceding in light of this news. The Subcommittee from the US House Committee on Oversight and Reform is calling on the FDA to get these products out of the hands of consumers. The subcommittee is the Economic and Consumer Policy.

This information goes along with a study from China that showed smokers in that country developed more serious symptoms and had to be hospitalized more often than other patients.

Young People Who Vape and Smoke are At Risk

An online survey was handed out in early May to teens and young adults under the age of 25. About half of the 4300 surveyed admitted to using e-cigarettes. The study showed that those who vaped had about three times the likelihood for being tested for COVID-19. Those who vaped and smoked had a five times higher rate of developing symptoms of the virus. These symptoms include coughing and fever as well as difficulty breathing and feeling fatigued.

Many young adults are already hooked on vaping and e-cigarettes. However, there are some programs that are tailored just for younger adults.

Some researchers also say that a direct correlation between e-cigarettes and COVID-19 hasn’t been made. While they believe that tobacco products do cause damage to the respiratory system and increase the infection rate, they cannot say for a fact that it causes an increased risk directly. However, all can agree that it appears that those young people who are using e-cigarettes are at a high risk for developing the coronavirus and possible complications.

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FDA Sets Limit for Acceptable Amount of Arsenic in Baby Cereal

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Cereal can contain arsenic from the grains it uses, but rice cereals are often higher in this toxic substance. The FDA has issued a limit for the amount of arsenic that can be found in rice cereal for infants. It is the first limit the agency has set up for arsenic in any food.

Arsenic in Baby Cereal

Rice is a grain with a high absorption rate for arsenic. It can end up with 10 times more of the metal than other grains. Because rice cereal is usually one of the first solid foods given to babies, it can have a significant impact on development.

Babies may eat multiple servings of rice cereal in a day, which can lead to exposure to inorganic arsenic, which is toxic. It can damage the neurodevelopmental system and harm their IQ.

Arsenic in rice cereal isn’t a new issue. Testing revealed that over 60 percent of rice cereals and other products have arsenic in them back in 2012. Since then, agencies have called for limits on the amount found in these products. Now, eight years later, the FDA has determined a limit of 100 parts per billion for arsenic in infant rice cereal. Other agencies have called for a lower limit.

While this limit is important news to manufacturers of baby cereal, it’s not enforceable. It is voluntary for manufacturers to follow these guidelines. The FDA conducted tests in 2018 on baby rice cereals, looking at the amount of arsenic present. About three-fourths of the products were at or below the new 100 ppb limit.

While critics believe this is an important first step to controlling the amount of arsenic that enters an infant’s system, they say more still needs to be done. Other products should be included, according to consumers advocates. Apple Juice is another product of concern. Experts believe it should be treated the same as drinking water with a limit of 10 ppb.

The Dangers of Arsenic

According to consumer advocates, limits should be given for all heavy metals, including lead and cadmium. The goal should be lower to reduce risk for children.

Arsenic is a natural element, which means it occurs in nature. It can get into the food supply through the soil as well as in the water and air. Contamination can happen with mining or fracking. Volcanoes that erupt can create an increase in arsenic at the surface of the earth.

Long-term exposure of arsenic has been linked to certain types of cancer and skin disorders. Even short-term exposure can lead to nausea and vomiting and other side effects. Young children have a higher risk for learning and development issues, which is why the FDA monitors products for infants and younger people at a higher rate than with other products.

It is important for parents to be aware of these risks and to determine which products are safest for their children. The effects from exposure to arsenic may not be seen right away, but they may be serious.

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