WASHINGTON — It seems like an easy question to answer: Should the manufacturers of infant formula be allowed to add a new ingredient, found naturally in mother's milk, that many scientists believe may improve the vision of infants and could help children think better as they grow?
The ingredient, which is recommended for babies by the World Health Organization and the Commission of the European Community, is available in infant formula throughout Europe and Asia.
But it is banned in the United States, and the Food and Drug Administration has before it an expert-panel recommendation to continue that ban for up to five more years.
As the FDA weighs that recommendation, a pitched battle is raging between advocates and opponents of the ingredient, a long-chain fatty acid called docosahexaenoic acid, or DHA, which all agree is essential to the development of an infant's brain.
Charges of Conflict of Interest, Sloppy Science
Their highly polarized dispute--which includes charges of conflict of interest and sloppy science--offers an unusual window into the forces that can shape an important scientific and public health debate. The stakes are high: whether the millions of formula-fed American infants are getting the best nutrition possible.
"There is a virtual consensus of specialists in this field that [DHA] should be added to infant formula, and that it will make formula more like mother's milk," said Norman Salem, a senior scientist with the National Institutes of Health.
But the FDA advisors say that neither the safety nor usefulness of adding synthetically produced DHA has been conclusively established, and they urge extreme caution until final results are in. Panel members also accuse the pro-supplementation advocates of mounting an inappropriate political campaign by doctors to sway its recommendation, an effort that dumped more than 1,000 letters supporting DHA supplementation on the panel.
Advocates charge that the panel convened to review infant-formula ingredients for the FDA was unfairly weighted against their point of view, and that the financial concerns of a major formula maker appeared to be playing a role in that process. Formula-fed infants, they say, will get less-than-optimal nutrition as a result.
Ross Products of Columbus, Ohio, an infant-formula maker long opposed to supplementing with DHA, claims a fast-growing body of scientific research supports its position. Ross officials also point out that supplementing with DHA would be expensive.
"The jury is pretty close to (a verdict) regarding full-term formula," said William McLean, vice president for pediatric nutrition research at Ross, maker of Similac. "The scientific evidence is highly on the side of not adding."
In the middle of the dispute is University of British Columbia researcher Sheila Innis, who was the main fatty-acid expert selected for the formula panel. She has long urged great caution about adding DHA to formula, and she also has done considerable work with Ross. Critics charge the panel could not be fair and balanced with her as its primary fatty-acid expert.
Innis said she has been objective throughout and that the panel's recommendation last fall was based on the scientific research available. While acknowledging that she has worked with Ross, Innis said she has worked with other infant-formula companies, too.
Proponents of DHA "may well see me as a barrier," Innis said, but she was "walking a difficult line and just trying not to make a mistake by moving too quickly."
Brain Made Up of Water and Fats
The human brain, which many believe is the most complex organ in nature, is made up overwhelmingly of two substances: water and fats. Scientists estimate that from 50% to 60% of the brain's dry weight is fats, and DHA is one of the most abundant of those fats.
Scientists began to seriously explore the role and importance of these fatty acids in the 1980s. Infants, they found, accumulate DHA in their brains and retinas most rapidly between the third trimester of gestation and 18 months after birth, and use the DHA to build the outer membrane of nerve cells during those crucial first months of life.
Because the infant's body cannot convert other fatty acids into DHA very effectively, many scientists believe infants need DHA delivered from outside sources--from mother's milk or formula. While scientists found that mother's milk does provide high quantities of DHA and other fatty acids, they found that infant formula delivered no preformed DHA.