Aug 05, 2022
FDA: Infant Formula Update August 5, 2022
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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 (Product Origin): Nestlé Health Science (The Netherlands)
Product(s): Nestlé SMA Nutrition Althéra
Type of Formula: Specialty – Hypoallergenic, Extensively Hydrolyzed Formula for the dietary management of infants with cow’s milk protein allergy (CMPA) and/or multiple food allergies.
Estimated Quantity: 37,500 cans (about 33,000 pounds or about 495,000 full-size, 8-ounce bottles)
Availability: The product is expected to be available in August 2022.
More Information and Where to Find the Products: SMA Nutrition Althéra is intended for use under medical supervision. SMA Nutrition Althéra is a hypoallergenic, whey protein-based extensively hydrolyzed powdered formula intended for the dietary management of cow’s milk protein allergy and/or multiple food allergies. It is nutritionally complete and suitable from birth or for supplementary feeding from 6 months up to 3 years of age. Not suitable for galactosemia, glucose-galactose malabsorption, or lactose intolerance. It will be available for purchase online through the Nestlé Nutrition store at https://www.nestlenutritionstore.com/External Link Disclaimer.
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
SOURCE U.S. Food and Drug Administration
News Source: allongeorgia.com
Tags: baby formula shortage fda food and drug administration the agency’s the agency’s infant formula products powdered infant formula cow’s milk additional information the infant formula information information and caregivers available intended be available the product products to increase
Carlos Santana back on tour following stage collapse
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Carlos Santana is back on the road.
The legendary rocker returned to the stage in Connecticut on Friday, after collapsing during a show in Michigan last month.
The revered guitarist, 75, was pictured smiling while leaving the Four Seasons in downtown Manhattan last week, later taking the stage in CT, followed by a show at the Jones Beach Amphitheater in Long Island, New York.
Santana was forced to reschedule six shows of his “Miraculous Supernatural” 2022 Tour with Earth, Wind & Fire “out of an abundance of caution for [his] health,” the musician’s rep told Page Six last month.
Michael Vrionis, President of Universal Tone Management, also issued a statement at the time.
“I regret to inform you that the Santana band has postponed tonight’s show at Ruoff Music Center Noblesville, Indiana,” he said.He was forced to cancel several tour dates after the incident. Getty Images
“And, we are postponing the July 9 show at Riverbend Music Center in Cincinnati, Ohio; July 10 at American Family Insurance Amphitheater – Summerfest Grounds in Milwaukee, Wisconsin; July 12 at Walmart Arkansas Music Pavilion in Rogers, Arkansas; July 15 at Dos Equis Pavilion in Dallas, Texas; July 16 at Cynthia Woods Mitchell Pavilion in Woodlands, Texas.”
Vrionis added, “Doctor’s have recommended that Mr. Santana gets rest to recuperate fully. Carlos is doing well and is anxious to be back on stage soon. He just needs rest.He is currently on his “Miraculous Supernatural” 2022 Tour with Earth, Wind & FireWireImage
“Santana profoundly regrets that these postponements of his upcoming performances; but, his health is our number one concern. He is looking forward to seeing all of his fans very soon.”
The iconic rocker was transported off stage on a stretcher during his July 5 show, after he was overcome by heat exhaustion and dehydration.
He previously took a break from touring in 2021 when he underwent a heart procedure.Filed under carlos santana , concerts , health and fitness , music , 8/14/22