Child Health

FDA Issues Warning Letters to Three Infant Formula Manufacturers

Published

1 year ago

September 7, 2023

Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.

These warning letters for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. They reflect findings from FDA inspections of these facilities over the last several months. At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace.

Importantly, the FDA does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time. The agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market. Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market.

The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations. As part of this, the firms must, among other things, thoroughly conduct root cause investigations and perform subsequent cleaning and sanitation activities. Notably, firms also need to properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product. Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking. The FDA will assess the adequacy of the companies’ corrective actions in the agency’s review of the responses and during the FDA’s next inspection of each facility. During these inspections the agency will verify proper implementation of appropriate corrective actions taken by each company.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition. “Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious.”

Today’s actions are the latest in the FDA’s ongoing effort to strengthen the safety and resiliency of the infant formula supply in the U.S. In November 2022, the agency released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. As part of that strategy, the FDA has been working with Congress to strengthen our regulatory tools and increase funding to oversee the infant formula industry and has worked closely with the U.S. Center for Disease Control and Prevention (CDC) to support the Council of State and Territorial Epidemiologists decision to add invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. The agency has already started to hire staff as part of our work to establish a dedicated cadre of infant formula investigators and an Office of Critical Foods, both of which will strengthen the regulatory oversight of infant formula.

Healthy supply of infant formula available in the U.S. market

Consumers should know that the U.S. infant formula supply is healthy with in-stock rates at 85% or higher since the beginning of 2023. The current strength of this market can be largely attributed to the many actions taken by the FDA and other U.S. government partners through 2022 and 2023, which are outlined in the FDA’s National Strategy to Increase the Resiliency of the Infant Formula Market.

Ensuring the safety of powdered infant formula at home

Parents and caregivers should follow manufacturer instructions for preparing powdered infant formula. For babies less than 2 months old, born prematurely, or with weakened immune systems the CDC recommends, if possible, using ready-to-feed liquid infant formula. Liquid infant formula is made to be sterile (without germs) and is the safest option for infants not receiving breast milk. However, parents and caregivers can also take extra steps to prepare powdered formula for these infant groups by heating water to at least 158°F/70°C to help protect against Cronobacter, adding the powdered infant formula and mixing, and then cooling the formula to body temperature (98.6°F) before feeding.

However, certain metabolic and specialty products include statements on their packaging warning consumers against heating because heating that particular product above 100°F could result in a loss of vitamins and nutrients. Therefore, caregivers should be especially mindful of the manufacturer’s instructions included on the packaging for metabolic and specialty formulas.

The FDA will continue its regulatory oversight and engagement with industry to enhance infant formula safety, including continuing to conduct annual inspections of infant formula facilities, maintaining a dialogue with infant formula manufacturers on these issues, and furthering prevention-based research and activities.

In addition to around-the-clock regulatory work, the FDA remains steadfast in upholding the commitment to unify and strengthen the FDA Human Foods Program. This new vision comes as a result of the agency’s review of findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, at the request of the FDA Commissioner, following the agency’s infant formula supply chain response.

Source: FDA

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Daily News Staff

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Entertainment

Altitude Trampoline Park Announces Exclusive Partnership With Intelliplay

Published

2 weeks ago

September 28, 2024

Daily News Staff

Premier Family-Friendly Entertainment Launches State-of-the-Art Technology Feature, Intellibands, in Two Parks With Additional Roll-Outs Coming Soon

DALLAS /PRNewswire/ — Altitude Trampoline Park, the leading family-friendly entertainment franchise, announced today its exclusive partnership with Intelliplay, Inc., a brand that is revolutionizing the indoor family entertainment industry with a patented smart wristband and gamification platform. This partnership will introduce Intellibands to Altitude Trampoline Park locations, offering cutting-edge technology designed to elevate the park experience for guests and improve overall park management for operators.

The Intelliplay system, featuring the Intelliband, aims to increase satisfaction for both guests and franchisees. Intellibands are advanced rubber wristbands equipped with radio frequency identification (RFID) technology. Key benefits of this technology include immediate identification of guests with expired jump time, gathering precise location and tracking data, increasing guest engagement through leaderboards and other gamified elements, and providing a convenient method to make purchases that grow overall revenue.

Replacing standard paper wristbands, Altitude staff will now perform check-ins through Intelliplay, scanning the Intelliband to link it to each guest’s ticket. This process ensures guests’ Intelliband lights up appropriately, allowing for seamless entry into the park. Staff can also monitor guest locations in real-time through a park map view.

Guests can look forward to several exciting features, including leaderboards. These allow kids to compete and earn points, making each visit to Altitude more engaging. Additionally, parents receive text notifications when their child’s time is about to expire, with a simple process to extend the time via phone. Intellibands also alert staff and parents if a child attempts to leave the facility, further ensuring safety and security in the park.

“We’re thrilled to introduce Intellibands to our parks. Altitude has been a trailblazer in the family entertainment industry, but this partnership with Intelliplay allows us to enhance our system by creating a new cornerstone for innovative technology, indoor activity, and fun that makes visits to our parks even more appealing and convenient,” said Mike Rotondo, CEO of Altitude Trampoline Park. “We are committed to continually improving the guest experience and look forward to seeing the positive impact Intellibands will have at our parks.”

The first Altitude Trampoline Park to officially roll-out this technology will be in Mason, Ohio, followed by Richardson, Texas. Prior to the official launch in Mason, Altitude tested this technology among customers and received great initial feedback. Customers found the wristband to be very secure and comfortable to wear, and overall felt the wristbands made for a better experience.

Altitude Trampoline Park is owned by Indoor Active Brands, a platform company that focuses on indoor entertainment concepts. This year, Indoor Active Brands launched its latest brand, The Pickle Pad, an indoor pickleball playground featuring a chef-inspired restaurant and bar – Crave Social Eatery, as well as yard and social games for all ages. Established by NRD Capital, Indoor Active Brands utilizes industry experience in the family entertainment and restaurant industries to support and assist its franchisees.

The brand is actively seeking qualified candidates to help grow its footprint throughout the U.S. in Kansas City, MO, Raleigh-Durham, NC, Denver, CO, among others. To learn more about franchise opportunities and upcoming store openings, contact Mike Stout at Mike.Stout@ATPHQ.COM or visit www.altitudefranchise.com.

About Altitude Trampoline Park

Altitude Trampoline Park is a premier indoor adventure park offering cutting edge trampolines, games, programs, and celebrations for all ages. Altitude is the home for active family fun! The brands successful $10 Endless Jumps pass, is where members get the max. Guests can, infact, Jump Happy! with unlimited use of trampolines, soft play, basketball, dodgeball, interactive games and more providing a great way for families to stay together and play together all year long. Nearing 100 locations worldwide, Altitude parks are centrally located and easily accessible, making it the convenient, budget friendly choice for families in 2024. More information can be found at altitudetrampolinepark.com.

SOURCE Altitude Trampoline Park

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Lifestyle

Back-to-School Checklist: Ensuring a Healthy Start to the School Year

Published

1 month ago

August 29, 2024

Rebecca Washington

As summer winds down, the buzz of back-to-school preparations begins. It’s a time filled with shopping for school supplies, adjusting to earlier bedtimes, and setting up kids for a successful school year. While we often think of pencils, notebooks, and new backpacks, there’s another crucial aspect to consider—your child’s health. Ensuring they are physically and mentally prepared is just as important as having the right school supplies. Here’s a comprehensive health checklist parents should consider to ensure their children are set up for a healthy school year.

boy looking on a tidied desk at school. — Photo by Oleksandr P on Pexels.com

Annual Physicals and Required Paperwork

A yearly physical exam is essential to assess your child’s health and development. It’s a perfect time to update any necessary medication plans with the school nurse and handle all the required health paperwork. These exams are vital for catching health issues before they become problematic, ensuring your child is in the best shape to start the school year.

Up-to-Date Vaccinations

Make sure your child’s vaccinations are current. This not only includes the standard childhood vaccines but also the flu shot, COVID-19 vaccinations, and possibly the HPV vaccine. Checking in with your pediatrician can help clarify what vaccinations your child needs before heading back to school.

Focus on Mental Health

The transition back to school can be a stressful time for children and teens, potentially triggering anxiety and depression. Observing your child’s behavior for signs of stress and discussing any concerns with health professionals can help manage these issues early. Regular conversations about their feelings can also make a big difference.

Sports Physicals

For children involved in sports, a specific physical examination is necessary to ensure they can safely participate in physical activities. This physical includes assessments of overall health with a focus on cardiac and pulmonary functions, which are crucial for preventing emergencies such as sudden cardiac arrests in young athletes.

Concussion Awareness

Parents and young athletes should be informed about the risks and signs of concussions—common in sports like football, soccer, and cheerleading. Knowing what symptoms to look for and how to respond if a concussion occurs is essential for every parent and coach.

Proper Sleep Habits

Adequate sleep is foundational for academic success and overall health. Establishing a solid bedtime routine that allows for enough sleep is crucial. This might also mean making the bedroom a screen-free zone to avoid the sleep-disrupting effects of blue light from electronics.

Backpack Safety

Choose a lightweight backpack and ensure that it does not exceed 20% of your child’s body weight to avoid back problems. Opting for designs with padded shoulder straps and a waist belt can distribute weight more evenly.

Regular Eye Exams

Vision problems can significantly affect a child’s learning ability. An annual eye exam can detect issues that might impair their ability to see clearly, which is vital for optimal learning. Even if your child has passed a school screening, a comprehensive eye exam by a professional can catch problems that screenings might miss.

Navigating Screen Time and Online Safety

As technology becomes more engrained in learning, managing screen time and understanding online safety becomes more important. Creating a media plan that balances educational and recreational screen time can help prevent sleep disruption and exposure to inappropriate content.

By integrating these health checks into your back-to-school preparations, you can help ensure your child has a healthy, productive year ahead. Remember, readiness for school isn’t just about having the right supplies—it’s also about being mentally and physically prepared for the challenges of a new academic year.

Source: Hackensack Meridian Health via Newswise

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

Author

Rebecca Washington

Rebecca Jo is a mother of four and is a creative soul from Phoenix, Arizona, who also enjoys new adventures. Rebecca Jo has a passion for the outdoors and indulges in activities like camping, fishing, hunting and riding roller coasters. She is married to Rod Washington View all posts

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Lifestyle

The Importance of Clean School Transportation

Published

2 months ago

August 26, 2024

Daily News Staff

The Importance of Clean School Transportation

(Family Features) Across the country, more than 25 million children ride to school each day in school buses, most of which are powered by diesel and produce harmful emissions known to cause respiratory issues like asthma and bronchitis.

An alternative energy source, like propane, can provide children with a safe, clean and healthy ride to school. As an environmentally friendly and affordable energy source that is abundantly available, propane can help achieve a cleaner today and greener tomorrow for students.

Watch this video to learn more!

https://youtube.com/watch?v=XT6vzCDdk8M%3Fsi%3DFU6ZLnpGfsIsjjUI

Consider these reasons it’s important to clean up student transportation from the experts at the Propane Education & Research Council:

Propane reduces emissions in exhaust that negatively impact air quality by up to 96% compared to diesel.
Propane school buses provide a quieter ride than diesel buses, which means it’s easier for drivers to hear potential concerns and students arrive at school calmer and ready to learn.
Propane warms up quickly, providing a heated cabin for a comfortable ride during colder months.
Propane is affordable, allowing school districts to replace aging diesel buses three times faster than transitioning to an electric bus fleet.

Learn more about clean transportation options and the benefits of propane school buses at BetterOurBuses.com .

SOURCE:
Propane Education & Research Council