Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

Source: US Food and Drug Administration

For Immediate Release:
Statement From:
Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs – Food and Drug Administration

As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. 

The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

The FDA has been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could impact product performance. 

  • With industry guidance laid out in February and contingency plans already in place, we are well-positioned and committed to working with companies to evaluate and expeditiously address the potential impact of emerging and future viral mutations on COVID-19 tests, therapeutics and vaccines.
  • We’ve taken a number of steps to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization, and quickly taking appropriate action.
  • The agency has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for health care providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations. 
  • We anticipate having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks. If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly.
  • On preliminary review, we believe high-volume polymerase chain reaction (PCR) and antigen (rapid) tests widely used in the U.S. show low likelihood of being impacted and continue to work. However, the FDA will continue to closely review and adjust course as needed.

The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts, to arm ourselves with the best available diagnostics, and life-saving therapeutics and vaccines to fight this virus.

At this time, the current vaccines remain highly effective at preventing COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. Additionally, currently available data from our international partners and vaccine manufacturers that has been evaluated by the FDA, suggests that an additional booster shot following the completion of a primary vaccination (six months for Pfizer-BioNTech and Moderna and two months for Janssen (Johnson & Johnson)) provides further protection against a COVID-19 infection.

Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends.

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Touting Fed $, Rosa Rides The E-Bus

Source: US Amalgamated Transit Union

Politicians shared a victory lap on the Connecticut Department of Transportation’s first electric bus Monday   —  and celebrated a future in which more routes and greener rides will be available for working-class people thanks to the new federal infrastructure law.

On her first full day as Hamden’s mayor, Lauren Garrett met with U.S. Rep. Rosa DeLauro, New Haven Mayor Justin Elicker, State Sen. Jorge Cabrera and State Rep. Robyn Porter in one of CT Transit’s garages, located on State Street in Hamden, where 12 new electric buses are scheduled to park in the coming weeks. (The Department of Transportation runs the state’s bus service through CT Transit.)

The point of the event: The state is buying the buses at $900,000 a pop out of the $1.3 billion that CT Transit will receive over the course of five years through the newly enacted federal Infrastructure Investment and Jobs Act.

DeLauro, a champion of the bill as chair of the House Appropriations Committee, hosted Monday’s event to show how the money will help local communities.

“Infrastructure is really the driver of economic development,” Garrett declared Monday. “Our economic development, our infrastructure really need to be two things: Equitable and environmentally sustainable.”

DeLauro noted that CT Transit runs over 22 local routes — many of which operate seven days a week — that connect individuals around New Haven and Hamden to Meriden, Waterbury, Milford, and the Lower Naugatuck Valley.


“People need the services to get to work, to get to school, to see their doctors, to see their loved ones,” DeLauro said. “Transit is a lifeline in this state.”

She reported that Connecticut lost more than 90 percent of its ridership during the height of the pandemic.

With people returning to work and recovering economically from the pandemic, DeLauro said, the federal funding will support those who were disproportionately impacted by Covid-19.

Nonwhite households, she noted, are two times more likely to commute by public transport than white ones. Purchasing more electric buses — as well as revamping railroads and constructing new bus-only lanes to facilitate faster travel — will increase access to employment opportunities while decreasing the amount of fossil fuels polluting neighborhoods and exacerbating health conditions like asthma, which plague communities of color more so than white ones.

Paul Farrell, the assistant director of air planning and standards for the Connecticut Department of Energy and Environmental Protection, told the Independent that on an annual basis, electric buses on average reduce carbon dioxide emissions by 92.1 short tons, carbon monoxide emissions by 0.15 short tons, and nitric oxide emissions by .43 short tons.

Plus, the upcoming construction needed to implement these changes will create countless jobs, the crew of politicians repeated. Establishing universal pre-k — as Hamden intends to do — and expanding child care across the country, DeLauro maintained, are important partner programs to support a healthy workforce.

“This is about health, this is about climate, this is about Rosa DeLauro being a champion for all of us at the capitol,” Justin Elicker summarized. How great is it, he noted, that a new mayor like Garrett can start off her first day in office with announcements of fresh funding.

“We can not only improve air quality locally and fight climate change globally, but we can also provide users of public transportation with the best technology we have to offer,” CTDOT Deputy Commissioner Garrett Eucalitto told his audience at the presser.

Then the group — including CT Transit workers — crowded onto the bus to test traveling around the block.

“You can tell it’s new because there are no fingerprints on the windows,” one passenger admired.

“It’s astonishing how quiet it is!” marveled another.

As the bus journeyed throughout town, DeLauro peppered Eucalitto with questions and chatted about the broader goals of the infrastructure plan.

In total, Connecticut is taking in $5.38 billion through 2026 to spend on infrastructure; that’s $1.63 billion more than from the most recent transportation bill enacted in 2015.

Eucalitto said the state’s last diesel powered bus was purchased last year. CT Transit owns 740 buses, all of which will be replaced with electric ones over the next 15 years (the maximum life span of the vehicles).

Electric buses cost around $300,000 more than diesel buses, which are valued at around $600,000. However, “purchasing isn’t the hard part,” Eucalitto explained. Most of the money will go towards retrofitting DOT’s garages to accommodate the buses, which means years of electrical work to successfully install new chargers.

Off the bus and away from the podium, Transit Union Chairman of the Connecticut Joint Bargaining Council Ralph Buccitti, described how he hopes to use the infrastructure bill to two Hamden Legislative Council members — Laurie Sweet and Justin Farmer — who attended the event along with Garrett.

It’s not just about high wage jobs, he said, but forty hour job guarantees. Because the infrastructure bill is not limited to capital expenditures, he wants the money to go towards an apprenticeship program to prepare individuals for full-time jobs in the field, investing in people and education rather than equipment alone.

Sweet suggested a partnership between the local garage and Hamden High, in line with Garrett’s goal of creating a pipeline between Hamden students and trade jobs.

“We still have to lobby and negotiate,” Buccitti reflected. But for once, “the money is here.” 

Union unhappy that Twin Cities light-rail cars may go to Louisiana for maintenance

Source: US Amalgamated Transit Union

It’s been 17 years since the Blue Line began service in the Twin Cities, and the system’s aging light-rail trains are in need of an overhaul.

Instead, transit officials appear poised to award a $7.7 million contract to a Florida company that will ship the cars by rail from the Twin Cities to Louisiana, where rust mitigation and other improvements will take place. The contract could total $12 million, to be funded by federal and local sources.

Metro Transit’s action “has the net effect of shipping union jobs and huge sums of taxpayer monies out of state because of [management’s] failures,” said Ron Kammueller, who represents light-rail maintenance workers with Local 1005 of the Amalgamated Transit Union (ATU), during a recent meeting of the Metropolitan Council’s Transportation Committee.

The committee was considering a contract calling for RailCar Co., of Sarasota, Fla., to work on 16 Bombardier light-rail vehicles, used primarily on the Blue Line linking downtown Minneapolis and the Mall of America.The contract was advertised a year ago, and RailCar Co. was the lone bidder.

The Met Council, which oversees Metro Transit, is expected to consider the contract at its Dec. 8 meeting.

Metro Transit officials maintain that if the contract isn’t awarded soon, the cost to get the work done may increase. Asked why the contract hadn’t gone before the council sooner — Metro Transit received the RailCar Co. bid in January — spokesman Howie Padilla said extra time was needed for “due diligence.”

“Under ideal circumstances, we would love to do this work in-house,” he said.

Rust mitigation on the cars began in 2017, with ATU workers completing the work on 11 aging vehicles. But the rust-busting program was slowed because of construction at Metro Transit’s Hiawatha Maintenance Facility, which was expanded to make room for future Southwest light-rail trains. The Southwest line is about 60% complete. though it’s still unclear when that service between Minneapolis and Eden Prairie will begin.

Shipping the older light-rail vehicles to Louisiana will give Metro Transit maintenance staffers a head start on rust mitigation for an additional 64 light-rail cars made by Siemens that have “far less severe” corrosion, according to the agency’s proposal.

“If we don’t do this to catch up, then the cars won’t last 30 years or so,” Padilla said. Metro Transit officials said last week they hope each vehicle will last up to 40 years with proper maintenance.

Minnesota’s harsh weather and the prolific use of road salt to combat ice and snow has led to rust on some light-rail vehicles — degradation that can be hard to spot unless the car is dismantled.

“The issue that we are facing is to get to that rust before it progresses to an advanced stage,” said Jay Wesley, project manager for Metro Transit, at the Transportation Committee meeting.

Kammueller said it’s doubtful RailCar Co. will employ union labor in Louisiana, a right-to-work state. It’s also unclear whether some of the work will be done by subcontractors.

A man answering the phone at RailCar Co. last week declined to comment on the contract or identify himself. Metro Transit contends the firm has done similar work for TriMet, the transit provider in Portland, Ore.; officials with TriMet were not available for comment.

Metro Transit claims that a dearth of maintenance workers in Minnesota also is contributing to the decision to outsource jobs. Though there were 41 openings for maintenance workers through August, Metro Transit was only able to hire two people.

Kammueller contended that Metro Transit has bungled an in-house apprentice program designed to attract workers.

Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

Source: US Food and Drug Administration

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:

Recall Reason Description

Inner lumen may detach from the device’s basket

Company Name:
Teleflex Incorporated
Brand Name:

Brand Name(s)

Arrow

Product Description:

Product Description

Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR


Company Announcement

WAYNE, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

The products involved in the recall are as follows. Additional detail about how to identify the affected products is available in the recall letter.

Product Code Lot Number Unique Device Identifier (UDI) #
PT-12709-WC 13F19K0564 (01)20801902156758 (17)210930 (10)13F19K0564
13F20C0094 (01)10801902121254 (17)220228 (10)13F20C0094
13F20G0284 (01)10801902121254 (17)220630 (10)13F20G0284
13F20L0282 (01)10801902121254 (17)221031 (10)13F20L0282
13F21A0497 (01)10801902121254 (17)221231 (10)13F21A0497
13F21A0718 (01)10801902121254 (17)230131 (10)13F21A0718
13F21F1187 (01)10801902121254 (17)230630 (10)13F21F1187
13X21E0008 (01)10801902121254 (17)230531 (10)13X21E0008
PT-65709-HFWC 13F19K0369 (01)10801902121292 (17)210930 (10)13F19K0369
13F20A0323 01)108019022121292 (17)211231 (10)13F20A0323
13F20B0139 (01)10801902121292 (17)220131 (10)13F20B0139
13F20C0594 (01)10801902121292 (17)220331 (10)13F20C0594
13F20F0083 (01)10801902121292 (17)220531 (10)13F20F0083
13F20F0230 (01)10801902121292 (17)220531 (10)13F20F0230
13F20F0577 (01)10801902121292 (17)220630 (10)13F20F0577
13F20H0756 (01)10801902121292 (17)220831 (10)13F20H0756
13F20K0849 (01)10801902121292 (17)221031 (10)13F20K0849
13F20L0283 (01)10801902121292 (17)221031 (10)13F20L0283
13F20M0182 (01)10801902121292 (17)221231 (10)13F20M0182
13F21A0498 (01)10801902121292 (17)221231 (10)13F21A0498
13F21B0158 (01)10801902121292 (17)230131 (10)13F21B0158
13F21C0747 (01)10801902121292 (17)230331 (10)13F21C0747
13F21E0555 (01)108019021212292 (17)230430 (10)13F21E0555
PT-65709-W 13F19M0129 (01)10801902121315 (17)211130 (10)13F19M0129
13F20B0053 (01)108019022121315 (17)220131 (10)13F20B0053
13F20C0595 (01)10801902121315 (17)220331 (10)13F20C0595
13F20F0231 (01)10801902121315 (17)220531 (10)13F20F0231
13F20G0361 (01)10801902121315 (17)220731 (10)13F20G0361
13F20K0632 (01)10801902121315 (17)221031 (10)13F20K0632
13F21A0353 (01)10801902121315 (17)221231 (10)13F21A0353
13F21C0748 (01)10801902121315 (17)230331 (10)13F21C0748
13F21D0721 (01)10801902121315 (17)230430 (10)13F21D0721
13F21E0823 (01)10801902121315 (17)230531 (10)13F21E0823
13F21F1189 (01)10801902121315 (17)230630 (01)13F21F1189
PT-65709-WC 13F19J0656 (01)20801902156741 (17)210930 (10)13F19J0656
13F19K0342 (01)20801902156741 (17)210930 (10)13F19K0342
13F19K0368 (01)10801902121308 (17)210930 (10)13F19K0368
13F20C0596 (01)10801902121308 (17)220331 (10)13F20C0596
13F20F0081 (01)10801902121308 (17)220531 (10)13F20F0081
13F20F0229 (01)10801902121308 (17)220531 (10)13F20F0229
13F20F0509 (01)10801902121308 (17)220531 (10)13F20F0509
13F20F0578 (01)10801902121308 (17)220630 (10)13F20F0578
13F20G0177 (01)10801902121308 (17)220630 (10)13F20G0177
13F20G0566 (01)10801902121308 (17)220630 (10)13F20G0566
13F20H0531 (01)10801902121308 (17)220831 (10)13F20H0531
13F20J0379 (01)10801902121308 (17)220831 (10)13F20J0379
13F20L0514 (01)10801902121308 (17)221031 (10)13F20L0514
13F21A0354 (01)10801902121308 (17)221231 (10)13F21A0354
13F21C0081 (01)10801902121308 (17)230228 (10)13F21C0081
13F21C0749 (01)10801902121308 (17)230331 (10)13F21C0749
13F21D0870 (01)10801902121308 (17)230430 (10)13F21D0870
13F21E0415 (01)10801902121308 (17)230430 (10)13F21E0415
13F21F1188 (01)10801902121308 (17)230630 (10)13F21F1188

Teleflex initiated this voluntary Field Safety Corrective Action on September 20, 2021 due to reports received indicating that the PTD’s Inner lumen (orange) detached from the device’s basket. Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR manufactured from October 2019 through July 2021 are subject to the recall.

If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes. In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. The lumen component is radio-opaque.

As of November 2021, a total of seven customer complaints have been received for this issue. In one complaint, a snare was used by the clinician to retrieve the detached lumen from the patient. No long-term patient complications have been reported.

On November 18, 2021, the U.S. Food and Drug Administration (FDA) classified the recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Consumers who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to Teleflex. The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://teleflex.widen.net/s/mdr28xv2pr/fsn—eif-000484_us

Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email recalls@teleflex.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted brands united by a common sense of purpose.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Arrow-Trerotola, Deknatel, LMA, Pilling, PTD, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.

Source:
Teleflex Incorporated:

Lawrence Keusch
Vice President, Investor Relations and Strategy Development

John Hsu, CFA
Vice President, Investor Relations

investor.relations@teleflex.com
610-948-2836


Company Contact Information

Why Retired Subway Workers Are Getting $35,000 to Come Back

Source: US Amalgamated Transit Union

In New York, the M.T.A. lifted a hiring freeze for certain workers in February after federal pandemic relief stabilized the agency’s finances and has made tackling crew shortages a priority. Still, the staffing shortages continue to cause thousands of subway and bus trips to be canceled every month, frustrating riders and hobbling the agency’s efforts to lure back the ridership it needs to address its financial woes.

“We have a specific problem with these crew-related delays, and we are attacking that aggressively because we don’t want to lose ground,” said Janno Lieber, the M.T.A.’s acting chairman and chief executive officer.

But hiring transit workers is not easy when there is a national labor shortage.

“Lots of industries are having trouble recruiting workers,” said Ruth Milkman, a sociology professor at the City University of New York, adding that many people are not looking for jobs because they may have saved money during the pandemic or have to care for children or relatives.

Though transit jobs have traditionally been good jobs that are secure even in economic downturns, the pandemic highlighted the risks of working on a train or bus when other people work safely from home. At least 173 M.T.A. workers have died from Covid, according to the agency.

“If you have a choice — and you do have choices right now because so many employers are having trouble finding people — you might want to pick something safer and less physically strenuous,” Prof. Milkman said.

Many transit jobs also require special licenses or test-based certifications that require experience, which can further limit the pool of qualified applicants, said Nicole Smith, a research professor and chief economist for Georgetown University’s Center on Education and the Workforce. “I think people are interested in these jobs, but they don’t have the skills to get started right away,” she said.

Even when transit agencies find qualified workers, she added, it can take months to train them and even longer to replace all the experience and institutional knowledge lost when veteran workers retire. “As much as everyone wants to get this done in weeks or a couple of months, it’s going to take a couple of years,” she said.

How FDA Helps You Make Healthy Food Choices

Source: US Food and Drug Administration-1

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As you’re sitting around your kitchen table or walking into your favorite chain restaurant, or in the grocery store, you may wonder:

What should I feed myself and my family at home?

What about when we’re eating out?

Which of the many food options available would be a healthy choice, no matter where we’re eating?

To help you make healthy choices, FDA’s recent efforts will do two things: First, provide the information you need to make those choices.

Second, encourage and help food companies to reformulate, or change the recipes of products to produce healthier foods.

The New, Improved Nutrition Facts Label

For more than 20 years, the familiar Nutrition Facts label on packages at the grocery store has guided many consumers in making food choices for their families. To make the label even more useful, FDA has made changes in both format and content. Updated Nutrition Facts labels may be displayed on packages now but must be on packages by July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).

These changes include:

  • Highlighting information on calories and servings—two important elements in making informed food choices.
  • Listing additional nutrients. For the first time, “Added Sugars” must be on the label—both in grams and as a % Daily Value. (The % Daily Value tells you how much of the reference daily amount of a nutrient is in a single serving.) Scientific data shows that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugars, and this is consistent with the 2015-2020 Dietary Guidelines for Americans. On average, Americans consume 13 percent of their daily calories from added sugars—making it much harder to stay within individual calorie limits.
  • In addition to “Added Sugars,” Vitamin D and potassium also are now required to be listed on the label.
  • Serving sizes that more closely reflect the amounts of food people actually eat, so the nutrition information that is listed per serving will be more realistic. In addition, the number of servings and serving sizes are more prominent.

“Some of the changes, such as providing calories and servings in larger and bolder type, will help people see this important information more quickly,” says health scientist Claudine Kavanaugh, Ph.D., M.P.H., R.D. “Other changes, such as requiring that ‘added sugars’ be declared and that potassium and vitamin D be labeled, reflect changes in nutrition recommendations.”

Changes to what’s required on the label can also spur companies to adjust their recipes. For example, this happened in 2006, when FDA required that trans fat be declared on the Nutrition Facts label. Trans fat in foods declined dramatically, and companies are already announcing their plans to reduce added sugars in their products.

Menu Labeling: Calorie Counts No Longer a Mystery

More than one-third of the calories Americans eat and drink come from food and beverages consumed away from home, so consumers need nutrition information when they eat out. Calorie counts will now appear on menus and menu boards of establishments covered by the menu labeling rule, including chain restaurants, take-out and delivery food places, salad and hot-food bars, and even some movie theaters that are part of a chain with 20 or more locations. You may have noticed some places posting these calorie counts already, but all restaurants covered by the rule must post calorie counts in accordance with the rule by May 5, 2017.

Among the info you’ll see:

  • Calories from alcohol are often overlooked, so the counts for certain alcoholic beverages in food establishments covered by the rule will also be listed on the menu.
  • To help consumers put the calorie information in the context of their total daily diet, the rule calls for the following reminder to be included on menus and menu boards: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” This will be in sync with a similar footnote on the new Nutrition Facts label.
  • Certain vending machines, too, will post calorie counts for the foods they sell.

Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition, says, “Consumers are used to seeing calorie counts on the Nutrition Facts label for foods on supermarket shelves. Now, with menu labeling, they will have calorie information and access to other nutrient information when they eat away from home, as well.”

“When you know that lunch at a fast food chain can add up to a day’s worth of calories, it really puts it all in perspective,” she adds.

And other nutrition information, though not posted, will be available on request. Examples include information on sodium, saturated fat, fiber, and protein.

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Sodium: Developing Targets for Industry to Reduce Salt

And what about sodium? Americans currently consume on average 3,400 milligrams (mg) per day of sodium—almost 50 percent more than is recommended. Most of that comes from processed and prepared food.

Sodium already is listed on the Nutrition Facts label, but even if you read labels and choose carefully, it’s a challenge to limit intake to the recommended 2,300 mg per day. And restaurant foods also tend to be high in sodium.

Many in the food industry have taken steps to reduce the amount of sodium in their foods, but sodium levels still remain too high. So FDA has proposed voluntary short-term (two-year) and long-term (10-year) targets for reducing sodium in processed and prepared food.

In developing these targets, FDA found that sodium levels often vary greatly within food categories, providing evidence that reductions are possible. The agency is engaging food companies on the draft targets and will encourage companies to implement the finalized targets. This should help gradually reduce sodium in the food supply so that consumers who wish to reduce their sodium consumption can have increased food choices.

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Getting the Information You Need

“These initiatives all work together to address the American diet across the food landscape, including packaged and restaurant and retail foods,” says Mayne. “Whether it’s added sugar or sodium or any other ingredient, it’s about knowing what’s in your food and making informed choices.”

“At FDA, we’re consumers too. And as consumers, we want what you do for ourselves and our families—the best information about what we’re eating along with the knowledge that the FDA is working to ensure that we all have healthy choices,” Mayne says.

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Nutrition Facts Label Reboot: A Tale of Two Labels

Source: US Food and Drug Administration

The Nutrition Facts label that you may read when buying packaged foods or preparing a meal has undergone a makeover. It’s been updated by the U.S. Food and Drug Administration (FDA) to reflect updated scientific findings. These changes can help you make better-informed choices about the foods you and your family eat and help you maintain a healthy diet.

Manufacturers with $10 million or more in annual food sales have until 2020 before the new label is required, and manufacturers with less than $10 million in annual food sales will have until 2021. Some manufacturers have already started using the new label. In fact, at least 10 percent of packages being sold already carry the new label.

So until the deadlines, you may see one of two different versions on packages: either the original label you’ve grown accustomed to using, or the new label.

What’s the Difference Between the Two Labels?

While both versions provide useful information, the new label reflects updated scientific information, including our greater understanding of the links between diet and chronic disease. It is also more realistic about how people eat today. Here are some of the changes:

1. The new label makes it easier if you or a member of your family is counting calories by putting the calories, the number of servings, and the serving size in larger, bolder type. We thought it was important to better highlight these numbers because nearly 40 percent of American adults are obese, and obesity is associated with heart disease, stroke, certain cancers, and diabetes.

2. FDA is required to base serving sizes on what people actually eat and drink, so serving size requirements have been adjusted to reflect more recent consumption data.  This way, the nutrition information provided for each serving is more realistic. For certain packages that contain more than one serving, you will see nutrition information per serving as well as per package. That means for a pint of ice cream, calories and nutrients are listed for one serving and the whole container. 

3. Added sugars are now listed to help you know how much you are consuming. The 2015-2020 Dietary Guidelines for Americans recommends you consume less than 10 percent of calories per day from added sugars. That is because it is difficult to get the nutrients you need for good health while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar.

4. Good nutrition means that you are getting the right amount of nutrients for your body to function correctly and to fight chronic diseases like obesity, heart disease, certain cancers, and type II diabetes. The FDA has updated the list of nutrients required on the label to include Vitamin D and Potassium because Americans today do not always get the recommended amounts of these nutrients. Conversely, Vitamins A and C are no longer required, because deficiencies in these vitamins are rare today, but they can be listed by manufacturers voluntarily.

5. The old label lists calories from fats, but the new label does not. The FDA made this change because research shows the type of fat consumed is more important than total fats. For example, monounsaturated and polyunsaturated fats, such as those found in most vegetable oils and nuts, can reduce the risk of developing heart disease when eaten in place of saturated and trans fat.

6. Daily values for nutrients like sodium, dietary fiber, and Vitamin D have been updated and are used to calculate the % Daily Value (DV) that you see on the label. The % DV helps you understand the nutrition information in the context of a daily diet. The footnote at the bottom of the label has changed to better explain the meaning of the % DV.

During this transition, no matter which label shows up on your food package, they both provide useful information to help you and your family make informed nutrition choices and maintain healthy eating patterns.

People Living With HIV in New York State Faced Increased Burdens From COVID 19 in 2020

Source: US Department of Health and Human Services

This study found that:

  • In New York State, people living with HIV were more likely to be diagnosed with, hospitalized for, and die in hospital from COVID-19 than were people without HIV.
  • People with more advanced HIV disease faced even greater risks from COVID‑19.

New York State has long been an epicenter of the U.S. HIV epidemic, and initially it was also an epicenter of the COVID-19 pandemic. Because HIV increases vulnerability to other infections, Dr. James M. Tesoriero and colleagues from the New York State Department of Health in Albany and the State University of New York, Rensselaer, investigated whether people living with HIV were more susceptible to coronavirus infection and to more severe COVID-19 disease than people without HIV. Their study demonstrated that compared with peers without HIV, people with a prior diagnosis of HIV in New York State were more likely to have a COVID-19 diagnosis, require hospitalization, or die from the disease during the first phase of the COVID-19 pandemic.

HIV Diagnosis Increases Risk of Severe COVID-19

The association of HIV and coronavirus infection had already been investigated in small studies of hospitalized patients with COVID-19. In this study, however, Dr. Tesoriero and his team linked information from state-wide databases recording HIV diagnoses, laboratory diagnoses of COVID-19, and hospitalization records to compare COVID-19–related outcomes of people with and without HIV among the entire population of New York State. Their analyses included data for more than 108,000 people previously diagnosed with HIV and more than 19.3 million people without HIV. Among these, almost 3,000 people with HIV and about 375,000 people without HIV were diagnosed with COVID-19 between March 1 and June 7, 2020.

Figure. People Living With HIV in New York State Were at Increased Risk of COVID-19 and Especially of Severe Disease  Between March 1 and June 7, 2020, people living with diagnosed HIV were more likely to be diagnosed with COVID-19, hospitalized, and die in hospital than those without HIV. After adjustment for demographic variables, risk of hospitalization and in-hospital death remained significantly increased. See full text description at end of article.

The analyses revealed that people with HIV were 43 percent more likely to be diagnosed with COVID-19, 161 percent more likely to be hospitalized with COVID-19, and 155 percent more likely to die in hospital with COVID-19, compared with those without HIV (see Figure). After adjusting for demographic factors, people with HIV had similar COVID-19 diagnosis rates as those without HIV but were more likely to have severe disease. “The likelihood of developing severe COVID-19 that required hospitalization appeared to explain elevated levels of hospitalization and death; persons with HIV still had 1.38 times the level of hospitalization compared to those without,” explains the study’s principal investigator, Dr. Eli S. Rosenberg. The findings are consistent with other studies showing that, compared with other populations, people living with HIV seem to experience more severe COVID-19 disease, but have similar outcomes once hospitalized.

Additional analyses identified subgroup differences among people with HIV. Blacks and Hispanics were more likely to receive a diagnosis of COVID-19; however, those who had COVID-19 were not more likely than Whites to have severe disease. Finally, the risk of hospitalization was greater the more advanced HIV disease was (i.e., the lower CD4+ T-cell counts were).

“Our results indicate that this population has experienced an increased burden of COVID-19 and requires particular attention from the clinical and public health communities,” says Dr. Rosenberg. What remains to be determined is the degree to which the increased COVID-19 severity is directly due to HIV rather than to other co-existing conditions or social factors associated with HIV.

This research was supported by NIDA grant DA051302.

Text Description of Figure

This bar chart shows the differences in COVID-19–related outcomes in people with and without HIV in New York State. Blue bars represent people living with HIV and gold bars represent people without HIV. The vertical y-axis shows the rate per 1,000 population on a scale from 0 to 30. The left pair of bars indicates the rate for COVID-19 diagnosis; it was 27.7/1,000 for people with HIV and 19.4/1,000 for people without HIV. The middle pair of bars shows the rate of hospitalization for COVID-19; it was 8.3/1,000 for people with HIV and 3.2/1,000 for people without HIV. The right pair of bars represents the rate of in-hospital death from COVID-19; it was 1.9/1,000 for people with HIV and 0.8/1,000 for people without HIV.

Source:

Tesoriero, J.M., Swain, C.E., Pierce, J.L., et al. (2021). COVID-19 Outcomes Among Persons Living With or Without Diagnosed HIV Infection in New York State. JAMA Network Open, 4(2), e2037069, 2021.

WAPO: In one California city, rising prices overshadow economy’s strength, spelling trouble for Democrats

Source: US National Republican Congressional Committee

The following text contains opinion that is not, or not necessarily, that of MIL-OSI –

WAPO: In one California city, rising prices overshadow economy’s strength, spelling trouble for Democrats

The Washington Post traveled to the battleground district of CA-25 – which Congressman Mike Garcia won by 333 votes – to find out what voters are worried about ahead of the 2022 election. 

SPOILER ALERT: It’s rising prices, and voters are placing the blame squarely on the shoulders of Democrats. 

In Case You Missed It…

In one California city, rising prices overshadow economy’s strength, spelling trouble for Democrats

Erica Werner

The Washington Post

November 30, 2021

https://www.washingtonpost.com/us-policy/2021/11/30/inflation-economy-california/

A 29-year-old hairdresser is weighing how much more to charge clients because of her rising costs. A 53-year-old property inspector could cancel family jaunts to scenic Monterey because gas is so expensive. And a 63-year-old power plant worker was so startled by the price of bread at the supermarket that he called his wife to make sure it was right.

As the economy picks up momentum in the final weeks of 2021, inflation fears are washing over this politically divided city north of Los Angeles. Consumer spending is strong and some residents acknowledge they’re more secure financially because of the stock market’s performance in the past 12 months. But as they watch prices go up at gas stations, grocery stores, restaurants and wholesalers, the painful sting of inflation is seeping deep into their mindsets, hardening political views that Democrats across the country could struggle to change ahead of next year’s midterm elections.

“I definitely think it’s not a coincidence that prices were lower in the last administration,” said Alina Sañez, a hairdresser who is fretting over how to pass the spiking costs of supplies she uses, such as disposable gloves, on to her clients.

Sañez said she is a registered Democrat but that her perspective has shifted as she’s watched economic trends impact her personally. As prices rise all around her, she said she holds President Biden responsible. She is telling clients that her $85 charge for a cut, color, and blow dry will no longer cover the blow dry. That will soon cost extra.

Voters such as Sañez could hold the fate of Congress’ Democratic majority in their hands next year. Santa Clarita, a city of around 215,000 some 30 miles northwest of Los Angeles, is part of California’s 25th congressional district, which elected a Republican House member by just 333 votes in the last election. Although its boundaries could change because of a redistricting process, the district is already being targeted by both political parties as they gear up for bruising midterm elections. Those midterms, less than 12 months away, could shift the balance of power in Washington and force Biden to reckon with an emboldened Republican majority.

The district’s current representative, Republican Mike Garcia, said local voters are rightfully concerned about rising prices, which he blamed partly on massive spending bills pushed by Biden and congressional Democrats. The most recent major initiative to become law, a $1.2 trillion infrastructure package enacted in mid-November, had some GOP support, though Garcia opposed it.

He said part of the case he will be making to voters is that they should elect a Republican Congress to put a check on Washington’s spending.

“The problems that we’re seeing are a direct result of the policies, and the policies are a direct result of, unfortunately, this Democrat party that has control of the House and Senate as well as the White House,” Garcia said in an interview, reiterating a common GOP refrain. “Right now, the groupthink mentality that we are suffering from is one of spending our way out of problems when it comes to the economy.”

Economists disagree about how big a role the trillions in relief and stimulus approved by Washington over the course of the pandemic have had on inflation, which is on its highest trajectory in decades. Prices jumped more than 6 percent in October compared with last year. This is happening, in part, because the economy is snapping back from a historic shock after the coronavirus pandemic closed thousands of businesses and led more than 20 million people to lose their jobs in March and April 2020. Most of those workers have been rehired and the economy is springing back to life.

The White House and congressional Democrats argue that the infrastructure bill and a massive social spending bill now pending on Capitol Hill would actually drive down inflation over time by helping companies transport materials more efficiently by sea, air and roads, a view some economists support. But that argument hasn’t won over every voter.

Christy Smith, a Democratic former state legislator who lost narrowly to Garcia and is seeking a rematch next year, said she backed Biden’s agenda, which she said would help lower inflation while also providing needed services that Garcia has voted against.

“I understand people’s concerns, especially here in a district where, for instance, the price of gas is something that impacts a lot of families here who commute to greater parts of Los Angeles for work,” Smith said in an interview. “On the other hand, you don’t see any saber-rattling out of the Republican side about other costs that are really driving families to the brink right now, like child care, like the cost of prescription drugs and health care, like housing.”

In Santa Clarita, almost 2,700 miles from the White House, residents have a mixed view of what’s happening.

In interviews with about two dozen residents the week before Thanksgiving, some welcomed the passage of Biden’s $1.2 trillion infrastructure law, which they said could bring needed investments to an area that got slammed during the pandemic partly because its largest employers include Princess Cruises and the Magic Mountain amusement park, companies that rely on tourists and travel. But for many, their concerns were more immediate, like why they had to pay nearly $5 for a gallon of gas, and around the same for a loaf of whole-grain bread at a local Vons supermarket.

“I actually called my wife to see if that’s the right price,” Richard Parker, a 63-year-old power plant worker, said after emerging from the grocery store with his cart loaded down with Thanksgiving supplies. He’d purchased two loaves of bread for his wife’s holiday stuffing, settling on one higher-quality variety and one package of Wonder Bread, which was comparatively cheap at $3.59 a loaf.

“Everywhere you go it’s more expensive,” Parker said. Like Sañez and others, he blamed Democrats and the Biden administration, questioning whether the infrastructure law would do anything to help him in the short term, and voicing concerns over whether a daughter who lives near San Diego would have to pay more in rent.

At the same time, Parker acknowledged he was benefiting from a strong stock market that has boosted his and his wife’s retirement savings. The Dow Jones industrial average has risen from 26,852 on election day in 2020 to more than 35,000 today, roughly one year later.

But he was reluctant to give Democrats any credit for that, and it didn’t change his overall pessimism about the economy.

“I don’t even know why it’s going so good when everything else is going poorly,” Parker said of the stock market, which has been buoyed by strong corporate earnings and consumer demand, among other factors.

The views expressed by residents in Santa Clarita largely align with results from a Washington Post-ABC News poll in November that found 70 percent of Americans pessimistic about the economy, with Biden’s approval rating at new lows and voters more inclined to pick a Republican congressional candidate than a Democratic one.

These results underscore what’s evident from talking to people here — that Democrats have largely failed to convince voters that the economy is actually doing pretty well. In addition to the strength of the stock market, the unemployment rate has fallen markedly, and workers can command higher wages. Yet the high prices staring residents in the face every time they leave the house seem to block out everything else.

“It looks great on paper but doesn’t affect us in any way, shape or form,” another local resident, John Haymond, said of the stock market. At 53, he’s not about to retire from his job as a property inspector, so his retirement account doesn’t help him now, he said. Instead, he’s worried that with gas prices so high, he’ll have to curtail family drives to Montereyup the California coast.

“It’s going to impact our ability to travel,” Haymond said outside a Walmart. “Maybe some of the decisions the president is taking have taken a drastic toll.”

Gas prices in California tend to be among the highest in the nation, and in November reached record highs averaging over $4.70 a gallon, an increase of almost 20 cents in one month, according to AAA. Biden has limited ability to impact the price of gas, however, and recently he called on the Federal Trade Commission to investigate oil and gas companies and accused them of “anti-consumer” actions leading to higher prices.

Not all residents were complaining about higher prices. Nancy Jones, 70, a retired elementary school teacher, said she’d noticed prices “inching up,” but said she hadn’t really been affected — she drives a compact car and described herself as “a cheap date.”

Jones, a Democrat, blamed Republicans for obstructing Biden’s agenda, adding, “One of the things that disturbs me most is the divisiveness.”

Another resident, Christa Lopez, said she’d just bought a turkey from Costco for $1-a-pound, which she considered a good price.

“Considering covid, I expected it to be worse,” Lopez said of economic conditions generally.

Department of Energy Awards over $16 Million for 23 Projects that will Reduce Carbon Emissions Across the Manufacturing Sector

Source: US Office of Energy Efficiency and Renewable Energy

Today, the U.S. Department of Energy (DOE) and the REMADE Institute announced more than $16 million in research and development funding for 23 projects that will reduce energy use and carbon emissions associated with industrial-scale materials production, processing, and recycling. These projects will advance the technology needed to increase the reuse, remanufacturing, recovery, and recycling of industrial materials.  
“The transition to a net-zero greenhouse gas economy will require an unprecedented reduction in the embodied energy and carbon emissions associated with foundational industrial materials in every critical sector—from healthcare, to agriculture, to transportation,” said Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy Kelly Speakes-Backman. “By investing in technologies that improve our ability to re-use, recycle and remanufacture these materials, DOE is moving America toward a circular economy and reducing carbon emission across the manufacturing sector.”   
Selected projects focus on reducing the consumption of raw materials, designing and using products more efficiently, and preserving and extending the lifecycle of products. Projects were selected in the following areas:  
Industry-led, transformational project that will develop and demonstrate technology solutions with the potential to revolutionize the recycling industries.
Traditional R&D projects that will increase material reuse, remanufacturing, recovering, and recycling and identify strategic opportunities to reduce the energy use and emissions associated with materials production, processing, and recycling.
Education and workforce development projects fostering the next generation of clean energy manufacturers through curriculum focused material reuse, remanufacturing, recovering, and recycling.  
View a list of selected projects here.  
Founded in 2017, the REMADE Institute is the fifth clean energy manufacturing institute funded by DOE’s Office of Energy Efficiency and Renewable Energy’s Advanced Manufacturing Office.  
Visit the REMADE Institute website to learn more.