National Coalition for Infant Health Submits Comment to FDA Regarding Infant Formula Labeling

November 7, 2016


Susan T. Mayne, Ph.D.

Director, Center for Food Safety and Applied Nutrition (CFSAN)

c/o Division of Dockets Management (HFA-305),

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852


Re: Docket Number FDA-2016-D-2241 for “Substantiation for Structure/Function Claims

Made in Infant Formula Labels and Labeling.”


Dear Dr. Mayne:


On behalf of the National Coalition for Infant Health (NCfIH), we write to share concerns regarding the Food and Drug Administration’s Draft Guidance for Industry “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.” The coalition applauds the FDA for raising this important issue on infant formula labeling and we encourage your office's oversight on this topic moving forward.


The National Coalition for Infant Health is a collaborative of professional, clinical, community health, and family support organizations focused on improving the lives of premature infants through age two and their families. NCfIH's mission is to promote lifelong clinical, health, education, and supportive services needed by premature infants and their families, and promote access to approved therapies. NCfIH also supports policy that meets our mission, impacting the family, community, state, and federal levels.


Fundamentally, NCfIH believes that labeling guidance should make clear that human milk is the recommended source of nutrition for all infants. Infant formula is a food product that may be used as a substitute only when an exclusive human milk diet is not available. Of note, not only is an exclusive human milk diet optimal for all infants, clinical evidence demonstrates that it should be the standard of care diet for all pre-term infants in order to reduce life-threatening infections and co-morbidities, decrease length of hospital stays and readmissions, and improve pre-term infants’ weak immune systems.


Additionally, the NCfIH and our member organizations urge FDA to use the labeling guidance to ensure labeling is clear, transparent, easy to understand, and devoid of information, titles or claims that may mislead consumers about the nutritional benefit of formula. Evidence-based clinical research must match the label, title and product content. It should be clear that bovine and other sources of protein should not be considered the dietary equivalent of human milk.


While infant formula is a core nutritional component of many infants and toddler diets, FDA labeling guidance must ensure that any labeling, packaging and marketing of formula not lead consumers away from the evidence-based, optimal nutrition source: exclusive human milk (mother’s own milk, qualified human donor milk, and human milk-based human milk fortifiers) for premature infants.


Last, the label should be clear that any nutritional supplements or human milk fortifiers added to formulas that are not exclusively human milk based must not mislead consumers to believe those additives replace or match the quality of an exclusive human milk diet.


An exclusive human milk diet is the recommended source of nutrition for all infants, so it is imperative that labeling guidance ensures consumers are not misled to believe that formula is an adequate substitute for the above-mentioned standard of care diet. To do so would present possibly dire and/or life-changing consequences, especially among the pre-term infant population.


NCfIH appreciates the opportunity to comment on this important issue and looks forward to continuing to support policies that benefit premature infants.



Mitchell Goldstein, M.D.

Medical Director, National Coalition for Infant Healt

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“Premature infants are a fragile and often voiceless population who face serious health challenges and barriers to accessing physician recommended therapies. Their families carry a disproportionately heavy emotional and financial burden. This summit will educate policymakers and the media and bring awareness to the issues these most vulnerable babies faces.” 


Experts include: Maushumi Assad, MD, MPH, Connecticut Children’s Medical Center; Dawn Bolyard, CNS, Mercy Children’s Hospital; Deb Discenza, Founder, Preemie World; Scott Eaker, VP, Quality and Regulatory Affairs, Prolacta Bioscience; Mitchell Goldstein, MD, Loma Linda University Children’s Hospital; Kelli Kelley, Founder, Hand to Hold; Leonard Krilov, MD, Winthrop University Hospital; Cheryl Milford, Ed.S., Educational Psychologist; Raylene Phillips, MD, Loma Linda University Children’s Hospital; Suzanne Staebler, NNP, Emory University; Susanne Tropez-Sims, MD, Meharry Medical College; Stephanie Vaughan, Co-founder and President, The Morgan Leary Vaughan Foundation; Elizabeth Ward, MS, RD.


Every year, 450,000 babies – one in every nine – are born premature. Prematurity is the leading associated cause of infant death during the first year of life. Premature infants who do survive often face lifelong disabilities, including visual and hearing impairments, feeding and GI complications, cerebral palsy, chronic lung disease, and learning and other mental disabilities. Parents of premature infants often face emotional and financial struggles, with the economic toll of premature care on the nation’s health care system totaling more than $26 billion each year. 


The summit, sponsored by the Institute for Patient Access, Astra Zeneca, Prolacta Bioscience, and the National Fisheries Institute, begins on Thursday, September 15 at 8:30am. 


The summit is open to the press. Press interested in attending should RSVP to Susan Hepworth at no later than Wednesday, September 14.



Institute for Patient Access               

National Coalition for Infant Health   




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