INSIDER
Morning Briefing Dec. 12, 2020: FDA authorizes Pfizer COVID vaccine, Supreme Court rejects attack on Biden victory, Michigan minimum wage hike delayed
Read full article: Morning Briefing Dec. 12, 2020: FDA authorizes Pfizer COVID vaccine, Supreme Court rejects attack on Biden victory, Michigan minimum wage hike delayedThe US Food and Drug Administration is scheduled to hold a press conference on the first COVID-19 vaccine authorization. On Friday, the United States granted an emergency use authorization for the Pfizer COVID-19 vaccine. Officials recently announced that the stateโs scheduled minimum wage increase is not expected to go into effect on Jan. 1, 2021. The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 426,294 as of Friday, including 10,456 deaths, state officials report. New COVID-19 cases are slowing but deaths continue to rise in Michigan.
Live Stream: FDA holds press conference after granting emergency use authorization for Pfizer COVID-19 vaccine
Read full article: Live Stream: FDA holds press conference after granting emergency use authorization for Pfizer COVID-19 vaccineDETROIT โ The US Food and Drug Administration is scheduled to hold a press conference on the first COVID-19 vaccine authorization. On Friday, the United States granted an emergency use authorization for the Pfizer COVID-19 vaccine. With the authorization, the vaccine will ship via FedEx and UPS, with the two carriers splitting the country in half. The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 426,294 as of Friday, including 10,456 deaths, state officials report. New COVID-19 cases are slowing but deaths continue to rise in Michigan.
FDA extends pregnancy warning for common pain relievers
Read full article: FDA extends pregnancy warning for common pain relieversWASHINGTON โ Pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, federal health officials said Thursday, expanding the warning from three months. They can lead to kidney problems in the fetus that can result in low levels of amniotic fluid that fills the womb. In one exception, the FDA said the new warning does not apply to low-dose aspirin when recommended by a doctor. Federal regulators said they decided to extend the warning after finding 35 cases of the amniotic fluid problem reported to the FDA and reviewing similar examples in published research. Use of the pain relievers reduced amniotic fluid in as little as two days, in some cases, the FDA said.
Researchers collect trash to better understand teen vaping and smoking
Read full article: Researchers collect trash to better understand teen vaping and smokingSAN FRANCISCO - To better understand the vaping epidemic in high schools across the United States, researchers have turned to the ground. "Cannabis product waste represents an emerging issue," they wrote. The note detailed how contamination from e-cigarette product waste, tobacco product waste and cannabis product waste was studied at 12 public high schools in Alameda, Contra Costa, Marin and San Francisco counties between July 2018 and April 2019. Youth use of flavored tobacco products, including mint and all other mentholated flavors, is of particular concern," Mock and Hendlin wrote in the report. "Likewise, measures are needed to eliminate environmental contamination from e-cigarette, combustible tobacco product, and cannabis product waste in and around schools," they wrote.
Blue Bell recalls a batch of its 'Butter Crunch Ice Cream'
Read full article: Blue Bell recalls a batch of its 'Butter Crunch Ice Cream'Blue Bell recalls a batch of its 'Butter Crunch Ice Cream' for having a possible foreign object. Blue Bell Creameries issued a voluntary recall for half gallons of their 'Butter Crunch Ice Cream' due to the possibility of a foreign object in the product, the company announced on Tuesday. A consumer found a piece of a plastic tool inside their ice cream and contacted Blue Bell, according to the press release. If this matches the ice cream in your fridge, Blue Bell says to return it to the place of purchase for a full refund. In 2015, Blue Bell recalled all of its ice cream, frozen yogurt, sherbet and other frozen treats sold in 23 states after a listeria outbreak.
Teen use of flavored e-cigarettes has continued to rise, report says
Read full article: Teen use of flavored e-cigarettes has continued to rise, report saysThe report, released Thursday, said current use of flavored e-cigarettes -- defined as use in the past 30 days -- had increased among high school students since 2014 and among middle school students since 2015. Since 2009, federal regulations have prohibited flavored cigarettes other than tobacco or menthol, but no such federal prohibition applied to other tobacco products. The new report said 3.15 million middle and high school student tobacco users -- nearly two-thirds of them -- said they used any type of flavored tobacco products in 2018. E-cigarettes were the most commonly used type of flavored tobacco. The use of flavored smokeless tobacco, cigars, pipe tobacco and menthol cigarettes decreased among high school students during that time, the report said.
FDA, DEA crack down on more websites illegally selling opioids
Read full article: FDA, DEA crack down on more websites illegally selling opioidsThese warning letters come just months after the FDA issued a similar series of warnings to other opioid-selling website operators. The online networks that received the new warning letters, sent earlier this month, are Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship and Meds4U. The letters call for the website operators to immediately stop illegally selling the opioids to consumers in the United States. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online." Warning letters were also sent to dozens of websites last year on two separate occasions.
CVS pulls Zantac, similar drugs over cancer worries
Read full article: CVS pulls Zantac, similar drugs over cancer worriesDrew Angerer/Getty Images(CNN) - CVS Pharmacy has stopped selling Zantac, as well as its generic version of the heartburn medication, over concerns that they might contain a substance that could cause cancer. CVS, the largest pharmacy chain in the country, said over the weekend it was suspending sale of Zantac and other products which contain ranitidine until further notice. Zantac and its generic counterpart have not been recalled, a statement from CVS said, and the FDA has not recommended that patients stop taking ranitidine products. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan. Customers who have already bought the products can return them to CVS for a refund, CVS said.
FDA finds cancer-linked impurity in common heartburn drugs
Read full article: FDA finds cancer-linked impurity in common heartburn drugsSince last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan. So far, NDMA has been found in ranitidine in low levels and we are not calling for consumers and patients to stop taking ranitidine at this time," he said. The FDA will share more information with the public and industry as we learn more throughout the investigation." Woodcock said the FDA is working with international regulators and industry partners to determine the source of the ranitidine impurity.
6th person dies from vaping-related lung disease
Read full article: 6th person dies from vaping-related lung diseaseJustin Sullivan/Getty Images(CNN) - A sixth person in the United States has died from lung disease related to vaping, Kansas health officials said Tuesday. It's not clear what type of vaping products she used, the Kansas Department of Health and Environment said. As of Friday, there have been more than 450 possible cases of lung illness associated with using e-cigarettes reported to the CDC across 33 states and the US Virgin Islands. Tuesday, the American Lung Association warned that "e-cigarettes are not safe" and can cause irreversible lung damage and disease. A two-day congressional hearing was held in July to probe the company's role in the youth vaping epidemic.
New treatment approved for drug-resistant tuberculosis
Read full article: New treatment approved for drug-resistant tuberculosisThe US Food and Drug Administration approved a new treatment for highly drug-resistant tuberculosis, offering new hope in the fight against the world's most deadly infectious disease. (CNN) - The US Food and Drug Administration approved a new treatment for highly drug-resistant tuberculosis, offering new hope in the fight against the world's most deadly infectious disease. Drug-resistant strains are on the increase due to incomplete and challenging courses of treatment that last for more than 18 months. "Until very recently, people infected with highly drug-resistant TB had poor treatment options and a poor prognosis," said Dr. Francesca Conradie, principal investigator of the trial. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options," FDA Principal Deputy Commissioner Amy Abernethy said in a statement.
FDA reveals proposed graphic warnings for cigarette packs and ads
Read full article: FDA reveals proposed graphic warnings for cigarette packs and adsThe US Food and Drug Administration on Thursday issued a proposed rule that requires tobacco companies to place new graphic health warnings on cigarette packages and in advertisements. This draft version of the rule comes after a judge ordered last year that the FDA has "delayed" issuing a rule mandating such graphic warnings. There are 13 proposed warnings, which feature text statements accompanied by color images, and they represent the most significant change to cigarette labels in the United States in 35 years, according to the FDA. "With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public's understanding of the full scope of serious negative health consequences of cigarette smoking," he said. RAI is the parent company of R.J. Reynolds Tobacco Company in the United States.
FDA: Stop taking 'Miracle' solution
Read full article: FDA: Stop taking 'Miracle' solution(CNN) - People should stop using the "Miracle" or "Master" mineral solution products sold online as cures for autism, cancer, HIV, hepatitis, flu, acne and a host of other illnesses and diseases, the US Food and Drug Administration warned Monday. The products -- known by various names, including Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol and Water Purification Solution or WPS -- are sold from various websites as cures for a range of both severe and minor ailments. "Miracle Mineral Solution and similar products are not FDA-approved, and ingesting these products is the same as drinking bleach," said FDA Acting Commissioner Dr. Ned Sharpless. The man who discovered the product in 1996 and later made it famous, according to the MMS website, is James Humble. The MMS website did not respond to CNN's request for comment.
FDA: 127 reports of seizures, neurological symptoms related to vaping
Read full article: FDA: 127 reports of seizures, neurological symptoms related to vapingJustin Sullivan/Getty Images(CNN) - The US Food and Drug Administration has received 127 reports of seizures or other neurological symptoms possibly related to e-cigarettes, the agency announced Wednesday. The FDA said the reported cases occurred between 2010 and 2019, and in addition to seizures, some people reported fainting or tremors. Dozens of new reports, no clear patternsIn April, the FDA announced that it had received 35 reports of seizures related to vaping, particularly among younger users. There have been 92 new reports since then, but the FDA didn't announce any clear pattern across the cases. "Additional reports or more detailed information about these incidents are vital to help inform our analysis," Sharpless said Wednesday.
Teen vaping and tobacco quitline launches in 9 states
Read full article: Teen vaping and tobacco quitline launches in 9 states(CNN) - More teens in the United States are using e-cigarettes, and now there's a program specifically for youth who want to quit vaping or smoking. National Jewish Health, a hospital in Denver, launched the My Life, My Quit tobacco and vaping cessation program Monday for youth under the age of 18. Despite more teens using nicotine products, they weren't calling the National Jewish Health QuitLogix tobacco cessation program as expected, said Ylioja. During these sessions, coaches and teens come up with smoking or vaping cessation plans, strategies to handle peer pressure and overall goals. "There's no better thing you can do for your respiratory health than to quit smoking," Ylioja said.
Trader Joe's, Green Giant vegetables recalled due to Listeria risk
Read full article: Trader Joe's, Green Giant vegetables recalled due to Listeria riskSome packages of butternut squash, cauliflower, zucchini and vegetable bowls sold under the brands Green Giant, Trader Joe's and Signature Farms have been recalled, according to the FDA. (CNN) - Some packages of butternut squash, cauliflower, zucchini and vegetable bowls sold under the brands Green Giant, Trader Joe's and Signature Farms have been recalled, according to the Food and Drug Administration. Growers Express issued a full list of the products recalled. It includes:Green Giant Fresh Butternut Squash CubesGreen Giant Fresh Butternut Squash NoodlesGreen Giant Fresh Butternut Squash DicedGreen Giant Fresh Cauliflower Crumbles Fried Rice BlendGreen Giant Fresh Ramen Soup BowlGreen Giant Fresh Sweet Potato Cauliflower CrumblesGreen Giant Fresh Zucchini NoodlesSignature Farms Cauliflower CrumblesTrader Joe's Butternut Squash SpiralsTrader Joe's Zucchini SpiralsGrowers Express said it is sanitizing the factory and equipment involved and conducting additional safety tests. No other Growers Express products were involved in the recall.
San Francisco is 1st city in US to pass ban on e-cig sales
Read full article: San Francisco is 1st city in US to pass ban on e-cig sales(CNN) - San Francisco will become the first US city to effectively ban e-cigarette sales, after the city's board of supervisors voted in favor of an ordinance Tuesday. This includes sales in brick-and-mortar stores, as well as online sales shipped to a San Francisco address. This puts San Francisco -- where leading e-cig maker Juul Labs is headquartered -- at the center of a tense debate. Juul is also behind a ballot initiative that experts worry could roll back the city ordinance if voters approve it in upcoming elections. "If the federal government is not going to act to protect our kids, San Francisco will."