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.
Canada’s First Egg Bank Launches, Recruiting Ethnically Diverse Donors for Enhanced Donor Conceived Outcomes
TORONTO (Newswire.com) – Egg Bank Canada (EBC) proudly announces its official launch as Canada’s first egg bank, dedicated to providing immediate access to donor eggs while prioritizing the best outcomes for donor-conceived individuals, their parents, and the donors themselves. With a focus on diversity and a unique known donation option, EBC aims to revolutionize the landscape of assisted reproductive services.
Led by renowned fertility experts Dr. Clifford Librach and Dr. Abdul Munaf Sultan Ahamed, EBC has completed numerous donor cycles, solidifying its commitment to exceptional patient care and fulfilling the urgent need for accessible donor eggs in Canada. One of the cornerstones of EBC’s mission is to recruit ethnically diverse donors, recognizing the importance of offering a wide range of options to prospective parents seeking genetic diversity. By actively seeking donors from various ethnic backgrounds, EBC ensures that more individuals and couples can find a suitable match, increasing the chances of successful outcomes and fulfilling their dreams of parenthood.
EBC distinguishes itself through its commitment to empowered decision-making. The egg bank offers multiple options for donor-recipient relationships, including known, semi-known, and open ID arrangements. This enables donors and recipients to choose the level of contact and involvement they are comfortable with, fostering a sense of choice and control throughout the process.
However, what truly sets EBC apart is its additional legal agreement between all parties involved. By ensuring that patients and their donors fully understand their legal rights and obligations, EBC creates a supportive and transparent environment that safeguards the interests of all individuals involved in the donation process.
Dr. Clifford Librach, a pioneer in the field of fertility, expresses his excitement about the launch, stating, “Egg Bank Canada is dedicated to providing exceptional care and support to our patients while prioritizing the well-being of the donor-conceived individuals and their families. We firmly believe that we can help more individuals and couples achieve their dreams of building a family through our innovative approach and commitment to diversity.”
Dr. Abdul Munaf Sultan Ahamed, the IVF Scientific Director of EBC, adds, “Our team is thrilled to bring Canada’s first egg bank to life. We are committed to advancing the field of assisted reproductive services and ensuring that our patients receive the best possible care. With our emphasis on diversity and known donation options, we are confident that EBC will make a lasting impact on the lives of many.”
Egg Bank Canada invites individuals and couples seeking donor eggs and those interested in becoming donors to connect with them to learn more about their innovative approach to assisted reproductive services.
416-586-1648 ext. #5
Source: Egg Bank Canada
5 Tips to Keep Kids Healthy During the Holidays
(Family Features) As the year comes to a close, the weather gets colder and indoor festivities ramp up. Keeping children and their families healthy during the holidays should be a priority for everyone.
“While gathering with friends and loved ones is an exciting and important part of the holiday season, staying healthy should still be on top of your ‘to-do’ list,” said Drs. Tress Goodwin and Joelle Simpson, KinderCare medical advisors. “Simple actions can be some of the most effective at keeping everyone healthy to ensure this season is a joyous one.”
Consider these five tips from KinderCare’s medical experts to keep in mind throughout the holidays.
- Wash hands regularly. One of the simplest ways to prevent germ spreading is to wash your and your children’s hands often using soap and water or an alcohol-based sanitizer. Try to remember to wash your hands after leaving public places, before eating and after any diaper change or restroom visit. If someone in your home is not feeling well, wash your hands more often.
- Share joy, not germs. Try to distance yourself from anyone who is sick (like those with coughs and colds) and avoid close contact with others when you or your child are sick. Encourage children to cough or sneeze into their elbows if no tissues are available. As a good at-home practice, regularly clean and disinfect commonly touched surfaces such as toys, cabinet and doorknobs, counters and tabletops.
- Keep meals well-balanced. Offer a healthy snack before holiday treats or make healthier versions of holiday favorites. Consider healthy snack options like fresh vegetables, fruits and dip, dried fruits, nuts or roasted sweet potatoes that can boost immunity for children and help balance out sugary treats. It’s also important to remember to eat healthy portion sizes and encourage children to listen to their bodily cues for hunger and fullness. Avoid juices or other sugary drinks and encourage children to drink plenty of water.
- Schedule personal time and get plenty of rest. Festivities can be merry but also overwhelming, especially for young children. Loud music, bright lights, lots of people and changes in schedules can leave them feeling overstimulated, which can lead to emotional outbursts. Make sure to leave some time in your week for simple joys, like cuddling up to read a book together or quiet play with immediate family members, so children have a chance to step out of the hustle and bustle. Remember holidays are meant to be fun, not stressful. While it may be tempting to pack every day with fun-filled activities, try to maintain children’s routines, including nap and bedtime schedules.
- Stay active. No matter what the weather is like, kids still need time to be physically active. Indoor play can be just as effective as time spent on the playground. Get creative with at-home winter fun with activities like dance parties, scavenger hunts and kids’ yoga. You can also visit indoor locations such as malls and museums to get those legs moving.
For more information or tips on holiday eating, indoor exercise and keeping children safe during the holidays, visit KinderCare.com.
Local Retail Outlets for Legal Marijuana May Be Associated With Alcohol Co-Use Among High School Students: New Journal of Studies on Alcohol and Drugs Report
PISCATAWAY, N.J. (Newswire.com) – Given the increasing trend toward legalizing marijuana in many states, there is growing concern that underage youth may find the drug easier to access. In fact, a recent study reported in the Journal of Studies on Alcohol and Drugs suggests that in areas with local retail availability of legalized marijuana, high school students are more likely to use marijuana and alcohol together, as well as alcohol alone.
“Greater retail availability may ‘normalize’ marijuana use for young people, even if they are unable to purchase marijuana directly from retail businesses, and retail sales may introduce greater access through social sources,” says study lead author Sharon O’Hara, Dr.P.H., lecturer at the University of California Berkeley School of Public Health and associate research scientist at the Pacific Institute for Research and Evaluation.
For their research, O’Hara and colleagues used info from the 2010-2011 and 2018-2019 California Healthy Kids Surveys of 9th and 11th graders in 554 public high schools in 38 California cities. Students were asked how often they used marijuana and alcohol over the previous 30 days.
The researchers also calculated the density of marijuana and cannabis retail outlets in each area (the number of outlets per square mile within the city limits).
Among the full sample, O’Hara and colleagues found a significant interaction between recreational marijuana legalization and marijuana outlet density, indicating a greater increase in the likelihood of alcohol use and co-use of alcohol and marijuana in cities with higher retail availability of cannabis after the passage of recreational marijuana legalization. A positive association between recreational marijuana legalization and marijuana use was found in cities at all levels of marijuana outlet density.
That outcome was expected, but a closer look at the data found some surprising results.
“We were most surprised by the effects of recreational marijuana legalization on the co-use of alcohol and marijuana by subgroups of alcohol users versus cannabis users,” says O’Hara. “We found significant positive associations between recreational marijuana legalization and co-use for past-30-day drinkers but significant inverse associations between recreational marijuana legalization and co-use among past-30-day marijuana users.”
The researchers hypothesize that, since its legalization, marijuana use has been increasing in the general population of California adolescents, while alcohol use continues to decrease.
“Given that, among the full sample of high school students, the effect of recreational marijuana legalization was strongest in the cities with relatively high marijuana outlet density; attention should be paid to policies that limit the retail availability of marijuana,” says O’Hara.
“Regulatory policies can be considered at the state level and in local jurisdictions with zoning authority over retail marijuana businesses,” she says. “So, even if your state legalizes recreational marijuana, you may have the ability to regulate the number and location of retail marijuana businesses using local land use authority.”
Source: Journal of Studies on Alcohol and Drugs
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