Summary of the Joint National Institutes of Health and the Food and Drug Administration Workshop Titled “Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework”

TY - JOUR

T1 - Summary of the Joint National Institutes of Health and the Food and Drug Administration Workshop Titled “Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula

T2 - Considerations for an Assessment Framework”

AU - Donovan, Sharon M.

AU - Abrams, Steven A.

AU - Azad, Meghan B.

AU - Belfort, Mandy B.

AU - Bode, Lars

AU - Carlson, Susan E.

AU - Dallas, David C.

AU - Hettinga, Kasper

AU - Järvinen, Kirsi

AU - Kim, Jae H.

AU - Lebrilla, Carlito B.

AU - McGuire, Michelle K.

AU - Sela, David A.

AU - Neu, Josef

N1 - Funding Information: Funding for this workshop came solely from internal Eunice Kennedy Shriver National Institute of Child Health and Human Development . The funding agency had no input into the content of the manuscript. S.D. has current/recent grant funding from the National Institutes of Health , U.S. Department of Agriculture , ByHeart , General Mills , IFF , Kiowa Hakka Bio , and The National Dairy Council . She serves on advisory boards for ByHeart, Danone Institutes International, Danone North America, and the National Dairy Council. She has received speaking honoraria from Arla Foods Ingredients, Biostime, DSM, and the Nestlé Nutrition Institute. S.A. has current/recent grant funding from Perrigo nutrition on an unrelated topic. M.A. has current/recent funding from the Canada Research Chairs program, the Canadian Institutes for Advanced Research (CIFAR), the Canadian Institutes of Health Research , Research Manitoba , the Canada Foundation for Innovation , the Bill and Melinda Gates Foundation, the Manitoba Children's Hospital Foundation , Prolacta Biosciences , Mitacs , the Garfield Weston Foundation , Health Data Research UK , and Canadian COVID Immunity Task Force . She has received speaking honoraria from Medela, Prolacta Biosciences, AstraZeneca, BabyFriendly UK, and the Institute for the Advancement of Breastfeeding & Lactation Education. She has contributed without remuneration to online courses on breast milk and the infant microbiome produced by Microbiome Courses. She serves in a volunteer capacity for the International Society for Research on Human Milk and Lactation, the US Canada Joint Human Milk Initiative, and the United Nations Institute for Training and Research Experts Committee on Breastfeeding. She has consulted for DSM Nutritional Products and serves on the Malaika Vx and Tiny Health Scientific Advisory Boards. M.B., has current/recent grant funding from the National Institutes of Health and Ferring Pharmaceutical . L.B. has current funding from the National Institutes of Health , the Bill and Melinda Gates Foundation , and the Family Larsson-Rosenquist Foundation . He receives travel reimbursements from universities, foundations, and societies to speak at national and international grand rounds and conferences. K.H. has current/recent funding from The Dutch Dairy Association (NZO) and the China Scholarship Council / Sino-Dutch Dairy Development Center and serves as a scientific advisor to Tamarak Biotics and Those Vegan Cowboys. K.S. has current/recent funding from the National Institutes of Health , Bill and Melinda Gates Foundation , Aimmune Inc , Janssen R and D. She has received royalties from Wolters Kluver and consults for both DBV Technologies and Merck. J.K. has current/recent funding from the National Institutes of Health and Ferring Pharmaceutical . He is on the Board of Directors for Innara Health and serves on the Medical Advisory Board for Medela. He is a shareholder with Astarte Medical and Nicolette. M.M. has current/recent funding from the National Institutes of Health , U.S. Department of Agriculture , National Science Foundation , Bill and Melinda Gates Foundation , Idaho Department of Commerce , Idaho Beef Association , Pacific Northwest National Laboratory . She served on the Advisory Board for Danone North America. D.S. has current grant funding from the National Institutes of Health and the U.S. Department of Agriculture . J.N. serves on the Global Scientific Council for the Nestle Nutrition Institute, is on the Scientific Advisory Committees for Medela and Astarte, is the principal investigator of a multicenter clinical trial by Infant Bacterial Therapeutics and is a consultant for Glycome and Siolta Therapeutics. The other authors declare no conflicts of interest. Funding Information: Funding for this workshop came solely from internal Eunice Kennedy Shriver National Institute of Child Health and Human Development. The funding agency had no input into the content of the manuscript. S.D. has current/recent grant funding from the National Institutes of Health, U.S. Department of Agriculture, ByHeart, General Mills, IFF, Kiowa Hakka Bio, and The National Dairy Council. She serves on advisory boards for ByHeart, Danone Institutes International, Danone North America, and the National Dairy Council. She has received speaking honoraria from Arla Foods Ingredients, Biostime, DSM, and the Nestlé Nutrition Institute. S.A. has current/recent grant funding from Perrigo nutrition on an unrelated topic. M.A. has current/recent funding from the Canada Research Chairs program, the Canadian Institutes for Advanced Research (CIFAR), the Canadian Institutes of Health Research, Research Manitoba, the Canada Foundation for Innovation, the Bill and Melinda Gates Foundation, the Manitoba Children's Hospital Foundation, Prolacta Biosciences, Mitacs, the Garfield Weston Foundation, Health Data Research UK, and Canadian COVID Immunity Task Force. She has received speaking honoraria from Medela, Prolacta Biosciences, AstraZeneca, BabyFriendly UK, and the Institute for the Advancement of Breastfeeding & Lactation Education. She has contributed without remuneration to online courses on breast milk and the infant microbiome produced by Microbiome Courses. She serves in a volunteer capacity for the International Society for Research on Human Milk and Lactation, the US Canada Joint Human Milk Initiative, and the United Nations Institute for Training and Research Experts Committee on Breastfeeding. She has consulted for DSM Nutritional Products and serves on the Malaika Vx and Tiny Health Scientific Advisory Boards. M.B., has current/recent grant funding from the National Institutes of Health and Ferring Pharmaceutical. L.B. has current funding from the National Institutes of Health, the Bill and Melinda Gates Foundation, and the Family Larsson-Rosenquist Foundation. He receives travel reimbursements from universities, foundations, and societies to speak at national and international grand rounds and conferences. K.H. has current/recent funding from The Dutch Dairy Association (NZO) and the China Scholarship Council / Sino-Dutch Dairy Development Center and serves as a scientific advisor to Tamarak Biotics and Those Vegan Cowboys. K.S. has current/recent funding from the National Institutes of Health, Bill and Melinda Gates Foundation, Aimmune Inc, Janssen R and D. She has received royalties from Wolters Kluver and consults for both DBV Technologies and Merck. J.K. has current/recent funding from the National Institutes of Health and Ferring Pharmaceutical. He is on the Board of Directors for Innara Health and serves on the Medical Advisory Board for Medela. He is a shareholder with Astarte Medical and Nicolette. M.M. has current/recent funding from the National Institutes of Health, U.S. Department of Agriculture, National Science Foundation, Bill and Melinda Gates Foundation, Idaho Department of Commerce, Idaho Beef Association, Pacific Northwest National Laboratory. She served on the Advisory Board for Danone North America. D.S. has current grant funding from the National Institutes of Health and the U.S. Department of Agriculture. J.N. serves on the Global Scientific Council for the Nestle Nutrition Institute, is on the Scientific Advisory Committees for Medela and Astarte, is the principal investigator of a multicenter clinical trial by Infant Bacterial Therapeutics and is a consultant for Glycome and Siolta Therapeutics. The other authors declare no conflicts of interest. Funding and Conflicts of Interest available at www.jpeds.com

PY - 2023/4

Y1 - 2023/4

KW - bioactives

KW - composition

KW - formula

KW - human milk

KW - ingredients

KW - safety

UR - http://www.scopus.com/inward/record.url?scp=85146919083&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85146919083&partnerID=8YFLogxK

U2 - 10.1016/j.jpeds.2022.11.027

DO - 10.1016/j.jpeds.2022.11.027

M3 - Comment/debate

C2 - 36463938

AN - SCOPUS:85146919083

SN - 0022-3476

VL - 255

SP - 30-41.e1

JO - Journal of Pediatrics

JF - Journal of Pediatrics

ER -