Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities.
Company: Reckitt Nutrition/Mead Johnson Nutrition (Mexico)
Product(s): Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron)
Type of Formula: Base powder for Specialty Formula (amino acid-based formula)
Estimated Quantity: an initial shipment of 331K pounds of base powder which will be used to produce (about 469,000 cans or about 6 million full-size, 8-ounce bottles)
Availability: The PurAmino base will be produced in August, to then be blended and packaged in the U.S. and is expected to be distributed immediately following.
More Information and Where to Find the Products: PurAmino is a hypoallergenic, iron fortified, amino acid-based infant formula used for infants and toddlers with severe cow’s milk protein allergy and other food allergies. The product will be distributed primarily through hospitals and other healthcare settings and select retail stores.
The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history.
The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it.
The FDA issued guidance on May 16 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to further increase the quantity of domestically-produced product for the U.S. market. The agency has posted a webpage that will be updated with information about additional products headed to the U.S.
Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula
The agency’s around-the-clock work as part of the all-of-government efforts has already begun to improve supply and availability. The agency expects that the measures and steps it is taking, and the resumption of production at the Abbott Nutrition’s Sturgis, Mich., facility, will mean more and more supply is on the way or on store shelves moving forward.
The FDA continues to advise against making infant formulas at home or diluting formula. Parents and caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services also has additional information available at HHS.gov/formula, including information to help families find infant formula.
The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products.
The FDA will continue to dedicate all available resources to help ensure that safe and nutritious infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
- FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
- Powdered Infant Formula Recall: What to Know
- CDC Information on Cronobacter Infection and Infants
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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