News Room

In Response to Inquiries Regarding the Addition of DHA and ARA to Infant Formulas, the International Formula Council (IFC) Offers the Following Statement:

IFC’s* position:

U.S. infant formula manufacturers currently offer formulas containing docosahexaenoic acid (DHA) and arachidonic acid (ARA).  Formulas containing DHA and ARA have been shown to provide visual and mental development similar to that of the breastfed infant.  The decision to supplement formulas with these nutritional long-chain polyunsaturated fatty acids (LCPUFAs) was made following years of research studying the clinical effects of both DHA and ARA in infants.  The use of LCPUFAs in infant formulas has been reviewed and supported by the U.S. Food and Drug Administration, the American Dietetic Association and the Dietitians of Canada, the Codex Alimentarius Commission, the European Society for Paediatric Gastroenterology and Nutrition, the World Association of Perinatal Medicine and Child Health Foundation, the Food and Agriculture Organization and World Health Organization, the Commission of European Communities and the National Academy of Sciences. 

DHA and ARA are considered to be “building blocks” for the development of brain and eye tissue.  Research has demonstrated that DHA and ARA, both present in human milk, are physiologically important in prenatal and postnatal life during the period of rapid brain and eye development and throughout life as well.  DHA and ARA have been shown to rapidly accumulate in the brain during the last trimester prenatally and the first two years postnatally, and pre-clinical studies have also demonstrated their importance in visual and neural systems.

The IFC supports breastfeeding and the position of the World Health Organization, the American Academy of Pediatrics and other leading health organizations that breastfeeding is ideal, and offers specific child and maternal benefits.  However, for those mothers who cannot or choose not to breastfeed, infant formula is recommended.¹  Years of product development and careful clinical research have resulted in commercially available infant formulas that provide the appropriate levels of protein, fat, carbohydrate, vitamins, and minerals for a baby to sustain a rapid rate of growth and development without stressing the infant’s delicate and developing organ systems.  With the addition of DHA and ARA to infant formulas, the industry continues its commitment to provide the best nutrition for infants whose mothers cannot or choose not to breastfeed.

After reviewing the recent literature and current recommendations regarding LC-PUFA for term infant nutrition during the first months of life, a 2008 international expert working group on LC-PUFAs in perinatal practice led by B. Koletzko concluded that “the available evidence strongly supports benefits of adding DHA and ARA to infant formula.”² The panel stated that the addition of DHA and  ARA to infant formula “appears appropriate.”  Furthermore, the authors stated that, “a large database exists concerning not only the safety, but also the efficacy, of infant formula containing both ARA and DHA .  These facts, together, support the addition of both ARA and DHA when LC-PUFAs are added to formula.” 

Parents and health professionals can be assured infant formula is safe and nutritious.

U.S. Food and Drug Administration (FDA)
In May 2001, following an extensive review of the available scientific data supporting the safety of DHA and ARA, the FDA agreed that oils containing DHA and ARA are generally recognized as safe (GRAS) for use in infant formula.³  Additionally, in accordance with the requirements of the Infant Formula Act of 1980 and its subsequent amendments, any manufacturer wishing to add these oils to a specific infant formula was required to notify the FDA 90 days prior to the introduction of such a new formula, so that the agency could conduct an appropriate review of the scientific literature and testing that has been assembled by the manufacturer to demonstrate the formula’s ability to support growth as a substitute for breast milk.⁴

American Dietetic Association (ADA) and the Dietitians of Canada (DC)
The ADA and the DC have recommended the inclusion of DHA and ARA in infant formula and have highlighted the importance of DHA and ARA to infant health.  In their position statement on dietary fatty acids, the ADA/DC note “no adverse effects of feeding marketed infant formula containing both ARA and DHA in amounts found in human milk are known.  Because of possible benefits and lack of adverse effects, it is recommended that all infants who are not breastfed be fed a formula containing both ARA and DHA through at least the first year of life.”⁵

Codex Alimentarius Commission (CAC)
The CAC, a global body formed by the United Nations’ Food and Agriculture Organization and the World Health Organization, adopted in July 2007 the Revised Standard for Infant Formula and Formula for Special Medical Purposes Intended for Infants, which upholds the safety and provides for the optional addition of LCPUFAs to infant formulas.⁶

European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
ESPGHAN recommends the addition of LCPUFAs to infant formulas.  In 2005, an ESPGHAN-coordinated International Expert Group supported the addition of DHA and ARA to infant formulas.⁷  In 2006, the ESPGHAN Committee on Nutrition concluded that pre-term infants, when formula fed, should receive infant formula with provision of LCPUFAs.⁸

World Association of Perinatal Medicine (WAPM) and the Child Health Foundation
In 2001, the Child Health Foundation, under guidance from the WAPM, asked investigators in the field of LCPUFAs to review available scientific data and form a recommendation.  That working group supported the addition of DHA and ARA to infant formulas for term and premature infants.⁹  Further, a recommendation from the 2001 workshop was that investigators update its recommendation as additional data became available.  Therefore, in 2008, the same group of investigators reviewed the available scientific literature and endorsed its previous position.¹⁰

Food Agriculture Organization (FAO) and the World Health Organization (WHO)
FAO and WHO have recommended the addition of DHA and ARA to infant formula at the levels found in human breast milk.  In October 1993, a joint expert consultation concluded: “In view of the evidence on the higher efficiency of long-chain polyunsaturated fatty acids for neural development…and the data on premature infants…the long-chain polyunsaturated fatty acids should be included in infant formula.”¹¹

Commission of the European Communities (EC)
The EC states that DHA and ARA are considered safe for use as an optional ingredient for infant formulas.¹²

National Academy of Sciences (NAS)
In 2005, a panel organized by NAS developed a report on dietary reference intakes for various macronutrients, including dietary fatty acids like LCPUFAs, and supports the addition of DHA to infant formula in the amounts found in breast milk.  According to NAS, “n-3 polyunsaturated fatty acids provide DHA that is important for developing brain and retina.”¹³

Background

DHA is particularly required for the development of the cerebral cortex, the region of the brain responsible for language development and information processing, and plays a vital function in developing visual sharpness (acuity).  ARA is an important precursor for modulators/mediators of a variety of essential biological processes (e.g., the inflammatory response, regulation of blood pressure, regulation of sleep/wake cycle).  DHA and ARA are synthesized in the body from the precursor essential fatty acids, α-linolenic acid (ALA) and linoleic acid (LA), respectively, that are also present in human milk and infant formula.

Evidence that blood levels of DHA and ARA are typically higher in breastfed infants than in infants fed formulas not containing these LCPUFAs provided a basis for investigating the addition of DHA and ARA to infant formulas.  Studies suggest that premature infants may benefit the most from direct consumption of DHA and ARA.  Throughout the third trimester, a mother passes DHA and ARA to the baby through the placenta.  Postnatally, these nutrients are passed through human milk.  In the event that a baby is born prematurely, placental transport of DHA and ARA is interrupted, thereby reducing the baby’s total accumulation of ARA and DHA prior to birth.  Addition of the GRAS sources of DHA and ARA to preterm formula provides these important nutrients safely.  Studies show that formulas containing added DHA and ARA are safe and support visual and cognitive development. 

U.S. infant formula manufacturers continue to evaluate the potential benefits of adding nutritional fatty acids to infant formulas.  They also take very seriously their responsibility to provide safe and nutritious infant formulas to the millions of infants fed infant formula, often as the sole source of nutrition.  Millions of infants in the U.S. and worldwide have safely been fed infant formula with DHA and ARA and millions more continue to be fed every day.  The addition of DHA and ARA to infant formula is modeled on the levels present in breast milk.  Clinical studies did not find more adverse events in subjects fed DHA and ARA containing infant formulas.  There has not been an increase in diarrhea and vomiting complaints, as alleged by recent media reports, since introduction of these ingredients into infant formulas.

For additional information on DHA and ARA, please visit http://consumer.martek.com/infants/faqs/.  (Martek specializes in the production and refinement of DHA and ARA.)

March 2008

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*The IFC is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America.  IFC members are: Abbott Nutrition; Mead Johnson Nutritionals; Nestle Nutrition - USA; and Wyeth Nutrition.

References Cited:
1 The American Academy of Pediatrics, Section on Breastfeeding. Breastfeeding and the Use of Human Milk. Pediatrics. 2005; 115 :496-506.
2 Koletzko, B. Lien, E. Agostoni, C. et al.  The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations.  J. Perinat. Med.  2008; 36: 5-14.
3 The U.S. Food and Drug Administration, 2001.  Agency Response Letter GRAS Notice No. GRN 000041.
4 The Infant Formula Act of 1980. Public Law No. 96-359, 94 Stat. 1190 [codified at 21 U.S.C. §350(a), 301, 321 (aa), 331, 374(a)]. September 26, 1980.
5 Position of the American Dietetic Association and Dietitians in Canada: Dietary Fatty Acids. Journal of the American Dietetic Association, 2007. http://www.eatright.org/ada/files/PIIS0002822307014903np.pdf
6 Alinorm 07/30/26.
7 Koletzko et al. Global Standard for the Composition of Infant Formula: Recommendations of an ESPGHAN Coordinated International Expert Group. Journal of Pediatric Gastroenterology and Nutrition 2005; 41:584-99.. http://www.espghan.med.up.pt/position_papers/con_23.pdf
8 ESPGHAN Committee on Nutrition. Feeding Preterm Infants After Hospital Discharge. Journal of Pediatric Gastroenterology and Nutrition 2006;42: 596-603,. http://www.espghan.med.up.pt/position_papers/con_25.pdf
9  Koletzko  B, Agostini C, Carlson SE, Clandinin T, Hornstra G, Neuringer M, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001; 90: 460-4.
10 Koletzko et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J. Perinat. Med. 2008;36:  5-14.
11 Food Agriculture Organization/ World Health Organization. Fats and oils in human nutrition: Report of a joint expert consultation. Chapter 7. M-80 ISBN 92-5-103621-7, 1994. http://www.fao.org/docrep/V4700E/V4700E00.HTM
12 Commission of the European Communities. Working Document Draft Commission Directive of infant formulae and follow on formulae (Recast version). http://www.epha.org/IMG/pdf/Working_document_infant_formulae_EC_20040925.pdf
13 Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. 2005. http://books.nap.edu/openbook.php?record_id=10490&page=R2

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