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Report calls for more review of infant formula supplementation
Proposed guidelines would also address claims of retinal benefits.
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As infant formula commercials tout the benefits of essential fatty acids for retinal and brain development, a report from the Institute of Medicine is calling for guidelines to assess the safety of these additives and others.
Infant formula manufacturers began adding long chain polyunsaturated acids docosahexaenoic acid (DHA, an omega-3 fatty acid) and arachidonic acid (ARA, an omega-6 fatty acid) in 2002, when Mead Johnson Nutritionals introduced Enfamil Lipil to its product line.
Since then, two other manufacturers have also released infant formulas containing DHA and ARA. And one month after Enfamil Lipil hit supermarket shelves, baby food manufacturer Beech-Nut Nutrition Corp. introduced its own line of supplemented products.
Manufacturers and other advocates of DHA and ARA supplementation note that these formulas more closely resemble fatty acid-rich breast milk. Skeptics, however, question how much benefit these fatty acids will have on retinal function and whether supplementing all infant products might be too much of a good thing.
Report findings
The report by the Institute of Medicine (IOM) is designed to address some of these concerns. The report, issued in March, responded to a joint request from the Food and Drug Administration and Health Canada to assess the current process for evaluating additive ingredients.
“We thought the current system was pretty strong, but it could be improved,” said pediatrician Richard J. Deckelbaum, MD, chair of the IOM’s Committee on the Evaluation of the Addition of Ingredients New to Infant Formula. “When different new ingredients came up, they didn’t always follow the same process, and it seemed to make sense to have a more systematic framework.”
The new guidelines, if adopted, would expand upon the current Infant Formula Act, which sets required nutrient levels but does not address safety testing for new ingredients.
The addition of DHA and ARA was approved under the FDA’s “Generally Recognized as Safe” (GRAS) notification process. But according to Dr. Deckelbaum, GRAS does not address the unique nutritional needs of infants.
The proposed guidelines would require that manufacturers set up a panel of experts to assess which ingredients must undergo testing beyond GRAS. They also recommend that manufacturers “strengthen in-market surveillance, which until now is really just passive,” Dr. Deckelbaum said.
Safety of fatty acids
As the FDA considers new safety guidelines for formula, ophthalmic and pediatric researchers continue to debate the safety and efficacy of fatty acid supplementation.
Vision scientist Robert E. Anderson, MD, PhD, a researcher on fatty acids, said that there is “no downside” to supplementing infant formula with DHA and ARA, especially if manufacturers are careful to replicate the concentration found in breast milk, which is about 0.2%.
“DHA is in very, very high quantities in retina and in brain and in reproductive tissue. These are the most vital organs in our bodies,” Dr. Anderson said. “We do know that these fatty acids are not only participating in providing a membrane structure in which very important proteins reside, but DHA itself has been shown to be a molecule that will control transcription of certain genes.”
Role in the retina
In the retina, omega-3 polyunsaturated fatty acids make up the membranes that house light-absorbing photoreceptor pigments. These fatty acids must be constantly replaced because of their high susceptibility to oxidative damage, according to Dr. Anderson.
The body gets all of its fatty acids from the diet, he added. Infants get them from breast milk.
“Preterm infants would require [supplementation],” Dr. Anderson said. “In the last 2 months of uterine growth, there’s a tremendous need for these fatty acids for brain development and for retina development.”
Potential concerns
Pediatrician Winston Koo, MD, agrees that fatty acid supplementation to date has been appropriate. “The way we’re going, pretty soon there won’t be any commercial standard infant formula that’s unfortified,” he said. “I think that’s the direction that the industry is going, and I think that overall it’s not a bad thing.”
There is reason to be concerned, however, if infants receive excessive amounts of DHA and ARA, Dr. Koo said. That situation would occur if every manufacturer of infant nutrition products were to supplement their products with long chain polyunsaturated fatty acids.
Experimental data suggest that in large amounts fatty acids can cause changes at the cellular and molecular level, Dr. Koo noted.
“The saying that ‘little is good for you’ is fine, but ‘more is better’ with respect to fortification of all infant nutritionals is of some concern,” he said. “Except for a relatively brief period after birth, primarily in premature infants, the chances are [infants] don’t need enormous amounts of long chain polyunsaturated fatty acids in their diet once their own capacity to synthesize these fatty acids meets the body’s needs, and if everyone supplements everything, that’s when we may run into a situation where there might be too much of a good thing.”
Report recommendations
The guidelines issued by the IOM committee would extend growth study follow-up to 180 days, 60 days longer than the FDA had first proposed when it set out to reform the Infant Formula Act.
The IOM guidelines also recommend that manufacturers assess new ingredients for any tendency to cause allergies, interfere with abdominal microbes, hinder absorption of other nutrients or create an imbalance of nutrients.
Safety vs. efficacy
The proposed guidelines, however, do not explicitly address efficacy claims, and researchers are most divided on this in regard to DHA and ARA.
For instance, Dr. Anderson cited studies from the Retina Foundation of the Southwest that found that infants supplemented with omega-3 fatty acids showed improvements in visual acuity and stereoacuity. A recent study from the foundation reviewed seven clinical trials and found that DHA had a “strong and significant effect” on visual acuity responses at 4 months.
But Dr. Koo questioned the clinical significance of these results, particularly when vision is evaluated over a lifetime. “These data are short term and exactly what it means for day-to-day vision is not fully understood at this stage,” he said.
Dr. Deckelbaum noted that fatty acids would be a prime example of a formula additive that would warrant “active post-marketing surveillance,” including ongoing surveys of the literature for adverse or toxic effects. And while manufacturers would be looking for potential safety concerns, efficacy matters probably would be addressed as well, he added.
“The charge of the committee was really to address safety; it wasn’t a report on efficacy,” he said. “But what the committee did decide and suggest is that if you’re going to set up a panel or expert group to look at safety, there has to be some potential benefit to the formula.”
For Your Information:References:
- Robert E. Anderson, MD, PhD, can be reached at the Departments of Cell Biology and Ophthalmology, University of Oklahoma Health Sciences Center, 608 Stanton L. Young Blvd., Oklahoma City, OK 73104; 405-271-8250; fax: 405-271-8128; e-mail: robert-anderson@ouhsc.edu.
- Richard J. Deckelbaum, MD, can be reached at the Institute of Human Nutrition, Columbia Presbyterian Hospital, 3959 Broadway, New York, NY 10032; 212-305-4808; fax: 212-305-3079; e-mail: rjd20@columbia.edu.
- Winston Koo, MD, can be reached at Hutzel Hospital, Wayne State University, 4707 St. Antoine Blvd., Detroit, MI 48201; 313-745-7231; fax: 313-993-0198; e-mail: wkoo@wayne.edu.
- Koo WW. Efficacy and safety of docosahexaenoic acid and arachidonic acid addition to infant formulas: can one buy better vision and intelligence? J Am Coll Nutr. 2003;22:101-107.
- Uauy R, Hoffman DR, Mena P, Llanos A, Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr. 2003;143:S17-25.