ThePressReleaseEngine.com

Press Release
FDA Pathway Supports Long Term Stability Diversity of Safe  and Nutritious Infant Formula Supply in  the U S

☷FDA Pathway Supports Long Term Stability Diversity of Safe and Nutritious Infant Formula Supply in the U S

Food and Drug Administration
| 12| 2
   For Immediate Release: September 30 , 2022 Today , the U . S . Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U . S . to remain on the market . This will help ensure the U . S . continues diversifying its infant formula market and make families less susceptible to shocks in the infant formula market . Specifically , the FDA is continuing , under certain conditions , to exercise enforcement discretion relating to the importation and sale in domestic comm......erce of certain infant formula products as part of its effort to provide stable , longer - term access to safe and nutritious infant formula across the country . The FDA is communicating directly with , and has made available to manufacturers , the steps to take to continue marketing certain formulas under enforcement discretion while they work to meet all U . S . regulatory requirements . In July 2022 , the agency committed to developing a new framework for continued and expanded access to infant formula products for U . S . parents and caregivers . “We’ve made important progress toward improving the infant formula supply in the U . S . and paving the way for a more robust and diverse marketplace for the future . However , the FDA can’t do it alone . We’ll need to work with all stakeholders to evaluate what other steps could be taken to encourage a more diverse and resilient infant formula marketplace , ” said FDA Commissioner Robert M . Califf , M . D . “Manufacturers from around the world have demonstrated their commitment to helping bolster U . S . supply and , in turn , we are committed to continuing these flexibilities for their products to safely remain on the market while ensuring they meet our standards . ”In May 2022 , the FDA announced increased flexibilities for the importation of infant formula products to address the temporary supply shortage . The FDA has issued 16 enforcement discretion letters to eight companies across nine countries , which has helped to ease the shortage , replenish store shelves and diversify the supply of infant formula in the U . S . As of September 2022 , this work has resulted in the import , or planned import , of safe and nutritious infant formula , which the companies estimate to be about 403 million 8 - ounce bottles ( 18 . 9 million cans ) . Enforcement discretion for these products was set to expire Nov . 14 , 2022; however , under certain conditions outlined in the guidance , the new guidance extends that date to Jan . 6 , 2023 , or longer . Manufacturers currently marketing their products in the U . S . under enforcement discretion should send a letter to the FDA by Dec . 5 , 2022 , outlining their intent to pursue completion of all regulatory requirements . Upon receipt , the agency intends to evaluate the request to determine whether to extend the period of enforcement discretion and issue a new letter of enforcement discretion by Jan . 6 , 2023 . For manufacturers that receive a new letter of enforcement discretion , the FDA does not intend to object to the continued marketing of covered infant formulas in the U . S . through October 2025 while the manufacturers take steps to achieve compliance with all requirements that apply to their products . Some manufacturers may have most of the information needed to meet all U . S . requirements , and therefore , could achieve compliance fairly quickly , while others may need the full timeframe being provided . “The FDA remains committed to strengthening the U . S . infant formula market , ensuring one of the nation’s most vulnerable populations have access to safe , nutritious products , ” said Susan Mayne , Ph . D . , director of the FDA’s Center for Food Safety and Applied Nutrition . “In addition , we understand that the continued availability of infant formulas brought in through enforcement discretion is important for infants who started on a specific formula during the shortage and now are accustomed to that formula as an essential source of nutrition . ”All companies — including those who received enforcement discretion — seeking to market their products long term in the U . S . must ultimately comply with all regulatory requirements , including those related to safety , nutrient adequacy , labeling and packaging . The FDA continues to review submissions from infant formula manufacturers that are received through the established regulatory pathway . Among the requirements for infant formulas , the FDA specifies minimum amounts for 30 nutrients that must be included . For 10 of these nutrients , there are maximum amounts as well . In addition , any ingredient used in infant formula must be safe and suitable for such use . The FDA also has specific requirements for labeling infant formulas . Such requirements include directions for preparation and use , a pictogram showing the major steps for preparing infant formula , use by date , and instructions indicating whether water should be added . The requirements for imported or domestically produced infant formula are the same . Infant formulas also must meet the quality factor requirements in our regulations , namely , sufficient biological quality of protein and the support of normal physical growth of infants . Typically , these quality factors are demonstrated through specific types of studies detailed in the FDA’s regulations . Facilities that manufacture infant formula are also subject to inspection . Tips and Resources for Parents and CaregiversAs the supply of infant formula products continues to increase , consumers should have the utmost confidence that the infant formula products being marketed through these extended flexibilities have received a thorough review of the information provided by the companies , including details about each product’s nutritional adequacy and safety , microbiological testing results , and labeling information . The FDA has also evaluated the food safety practices at the facilities that manufacture the products marketed under enforcement discretion and will continue monitoring them as appropriate . The FDA has made available educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U . S . or already on store shelves . Additionally , the agency has created a series of short consumer videos of consumers’ most frequently asked questions .


30 September 2022 ( September 30 2022 )



Press release information:
Direct link to press release: Click here .


Was this page helpfull ?



Advertisment
FDA Pathway Supports Long Term Stability Diversity of Safe  and Nutritious Infant Formula Supply in  the U S
Advertisment

Similar from the same period

Press Release

Five New Aryan Empire Associates Sentenced to Prison

Bureau of Alcohol, Tobacco, Firearms and Explosives
Sep 30,2022

White Supremacists Gang Trafficked Drugs in Pope County Area LITTLE ROCK—Five defendants were sentenced yesterday for their involvement in crimes carried out on behalf of a white supremacist gang . Each defendant previously pleaded guilty to various crimes associated with the New Aryan Empire ( NAE ) , a white supremacist organization that began as a prison gang and functioned as a drug trafficking organization . [ . . . ]

Bureau of Alcohol, Tobacco, Firearms and Explosives
Press Release

The Trial of Félicien Kabuga for Genocide in Rwanda United States Department of State

U.S. Department of State
Sep 30,2022

The United States welcomes the opening statements in the trial of Félicien Kabuga at the Hague branch of the International Residual Mechanism for Criminal Tribunals ( IRMCT ) , the successor mechanism to the International Criminal Tribunal for Rwanda ( ICTR ) . [ . . . ]

U.S. Department of State
Press Release

Secretary Blinken s Meeting with Malawian President Lazarus Chakwera United States Department of State

U.S. Department of State
Sep 30,2022

The following is attributable to Spokesperson Ned Price:Secretary of State Antony J . Blinken met yesterday with Malawian President Lazarus Chakwera in Washington , D . C . Secretary Blinken outlined U . S . support for economic growth in Malawi , including the $350 million Millennium Challenge Corporation compact signed yesterday . [ . . . ]

U.S. Department of State
Press Release

FDA Approves New Treatment Option for Patients with ALS

Food and Drug Administration
Sep 30,2022

For Immediate Release: September 29 , 2022 The U . S . Food and Drug Administration today approved Relyvrio ( sodium phenylbutyrate/taurursodiol ) to treat patients with amyotrophic lateral sclerosis ( ALS ) , commonly referred to as Lou Gehrig’s disease . [ . . . ]

Food and Drug Administration
Press Release

Remarks by President Biden on Hurricane Ian and Ongoing Federal Response Efforts

White House
Sep 30,2022

FEMA HeadquartersWashington , D . C . 12:58 P . M . EDTTHE PRESIDENT: Well , first of all , excuse my back . ( Laughter . ) ( Addresses FEMA staff . ) You’re doing a hell of a job . No , no , no , you really , really are . [ . . . ]

White House
Press Release

Contracts For Sept 29 2022

U.S. Department of Defense
Sep 30,2022

NAVYDPR - RQ Construction , LLC , Carlsbad , California ( N62473 - 22 - D - 1403 ) ; Gilbane Federal JV , Concord , California ( N62473 - 22 - D - 1404 ) ; Hensel Phelps Construction Co . , Irvine , California ( N62473 - 22 - D - 1406 ) ; Kiewit Building Group Inc . [ . . . ]

U.S. Department of Defense
Press Release

Justice Department Awards $100 Million to Reduce Community Violence

U.S. Department of Justice
Sep 30,2022

The Department of Justice announced today grant awards totaling $100 million to help communities across the U . S . reduce gun crime and other serious violence . The announcement was made during a visit by Department officials to Baltimore , Maryland , home to three community - based organizations receiving funding under the Department’s Office of Justice Programs ( OJP ) Community Violence Intervention and Prevention Initiative . [ . . . ]

U.S. Department of Justice
Press Release

First Ever Secretary s Tribal Advisory Committee Convenes

U.S. Department of the Interior
Sep 30,2022

Committee leadership announced 9/29/2022 Date: Thursday , September 29 , 2022Contact: Interior_Press@ios . doi . govWASHINGTON — The Department of the Interior’s first - ever Secretary’s Tribal Advisory Committee ( STAC ) held its kick - off meeting this week . [ . . . ]

U.S. Department of the Interior
Press Release

Remarks by President Biden at the U S Pacific Island Country Summit

White House
Sep 30,2022

U . S . Department of StateWashington , D . C . 3:15 P . M . EDTTHE PRESIDENT: Well , I thought we’d give you a break , but they haven’t let in — haven’t let up at all . Thank you so very much . Folks , I think this has been — we’ve been looking forward to this for a long time . [ . . . ]

White House
Press Release

Assistant Attorney General Kristen Clarke of the Justice Department s Civil Rights Division and U S Attorney Trini E Ross for the Western District of New York Launch United Against Hate Program in Buffalo New York

U.S. Department of Justice
Sep 30,2022

Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division joined U . S . Attorney Trini E . Ross for the Western District of New York to announce a new initiative to combat unlawful acts of hate in the Western District of New York . [ . . . ]

U.S. Department of Justice
Press Release

Louisiana Man Pleads Guilty to Kidnapping a Gay Man as Part of Scheme to Kidnap and Murder Grindr Users

U.S. Department of Justice
Sep 30,2022

Chance Seneca , 21 , of Lafayette , Louisiana , pleaded guilty today before U . S . District Judge Robert Summerhays to one count of kidnapping . According to his plea agreement , Seneca admitted that on June 20 , 2020 , he used Grindr , a dating application for gay and bisexual men , to kidnap and attempt to murder H . [ . . . ]

U.S. Department of Justice
Press Release

With New American Rescue Plan Funding HHS Expands and Strengthens the Community and Public Health Workforce

U.S. Department of Health and Human Services
Sep 30,2022

HHS invests $225 . 5 million in community health workers , $40 . 7 million in public health scholarshipsToday , the U . S . Department of Health and Human Services ( HHS ) , through the Health Resources and Services Administration ( HRSA ) , awarded more than $266 million in American Rescue Plan funding to grow the community and public health workforce . [ . . . ]

U.S. Department of Health and Human Services
Press Release

Philadelphia Man Faces Federal Charges for Carjacking Mother and Daughter Outside Northeast Philadelphia Home Before School

Bureau of Alcohol, Tobacco, Firearms and Explosives
Sep 30,2022

PHILADELPHIA – United States Attorney Jacqueline C . Romero announced that Amir Harvey , 20 , of Philadelphia , PA was arrested and charged by Criminal Complaint with carjacking and carrying a firearm during and in relation to a crime of violence , in connection with a carjacking incident which occurred in Northeast Philadelphia earlier this month . [ . . . ]

Bureau of Alcohol, Tobacco, Firearms and Explosives
Press Release

FACT SHEET U S Israel Strategic High Level Dialogue on Technology

White House
Sep 30,2022

President Biden and Prime Minister Lapid launched the U . S . - Israel Strategic High - Level Dialogue on Technology in July to establish a partnership on critical and emerging technologies to bring the cooperation between the countries to new heights . [ . . . ]

White House
Press Release

FACT SHEET Biden Harris Administration Announces American Rescue Plan s Historic Investments in Community Health Workforce

White House
Sep 30,2022

$225 Million in Training Grants Awarded Today; American Rescue Plan Investments for Community Health Workforce Total Over $1 . 1 BillionToday , the Biden - Harris Administration is awarding $225 million in American Rescue Plan funds to train over 13 , 000 Community Health Workers ( CHWs ) . [ . . . ]

White House
Press Release

Readout of Secretary of Defense Lloyd J Austin III s Meeting With the Republic of the Philippines Department of National Defense Senior Undersecretary and Officer in Charge Jose Faustino Jr

U.S. Department of Defense
Sep 30,2022

Secretary of Defense Lloyd J . Austin III hosted a bilateral meeting today in Hawaii with Senior Undersecretary and Officer in Charge Jose Faustino , Jr . , Republic of the Philippines Department of National Defense . [ . . . ]

U.S. Department of Defense
Press Release

Secretary Blinken s Travel to Colombia Chile and Peru October 3 7 2022 United States Department of State

U.S. Department of State
Sep 30,2022

Secretary of State Antony J . Blinken will travel to Colombia , Chile , and Peru October 3 - 7 , 2022 . October 3 - 4 , in Colombia , Secretary Blinken will meet with President Gustavo Petro , Vice President Francia Márquez , and Foreign Minister Álvaro Leyva . [ . . . ]

U.S. Department of State
Press Release

Readout of Meeting with Health System and Hospital Leaders on Managing COVID 19 This Fall

White House
Sep 30,2022

Yesterday , White House COVID - 19 Response Coordinator Dr . Ashish Jha , Health and Human Services Secretary Xavier Becerra , Centers for Disease Control and Prevention Director Dr . Rochelle Walensky , and U . [ . . . ]

White House
Press Release

Mexican Resident Convicted for Trafficking Firearms Under New Law

Bureau of Alcohol, Tobacco, Firearms and Explosives
Sep 30,2022

LAREDO , Texas – A 25 - year - old U . S . citizen residing in Mexico has pleaded guilty to trafficking handguns into Mexico under the Stop Illegal Trafficking in Firearms Act , announced U . S . Attorney Jennifer B . [ . . . ]

Bureau of Alcohol, Tobacco, Firearms and Explosives
Press Release

DOE Welcomes New Biden Harris Administration Appointees

U.S. Department of Energy
Sep 30,2022

WASHINGTON , D . C . — The U . S . Department of Energy ( DOE ) today announced five new Biden - Harris Administration appointees who will work alongside U . S . Secretary of Energy Jennifer M . Granholm to pursue President Biden’s goals of 100% clean electricity by 2035 and a net - zero economy by 2050 — two goals that will be accomplished through the Inflation Reduction Act and Bipartisan Infrastructure Law . [ . . . ]

U.S. Department of Energy
Advertisment

Advertisment