Infant formulas can now be fortified with fatty acids, according to a recent U.S. Food and Drug Administration ruling. Both docosahexaenoic acid and arachidonic acid have received the Generally Recognized As Safe status from the government. The approval opens the door for U.S. manufacturers to add the acids to their formulas once they have satisfied FDA premarket notification procedures.

DHA and AA both occur naturally in breast milk and are necessary for the development of important human tissues, including the brain and retina. "A large portion of the brain—25 percent to 50 percent—develops after birth, so it's very important that the baby has the right nutrients to develop optimal brain and retinal tissues," said Angela Tsetsis, director of marketing and sales for Martek Biosciences Corp. in Columbia, Md. The FDA's GRAS approval was given to Martek's blend of DHA and AA.

Clinical studies have shown that infants benefit from DHA- and AA-enriched formulas. "Babies fed formulas with [DHA and AA] had both visual and mental developmental advantages versus babies fed formulas without," Tsetsis said. In addition to superior mental and visual abilities, children at 2 ¹/² years of age fed the enriched formulas also displayed better fine motor skills such as grasping, according to Tsetsis.

In spite of these findings, an article in the August 2001 issue of Pediatrics concluded that term infants fed DHA and AA supplemented formula showed no developmental benefits. According to Martek, the study used DHA derived from egg and fish oil sources, which have not undergone a safety review by the FDA for use in infant formula, and the study used very low levels of DHA supplementation, corresponding to the lowest amount found in breast milk. "The FDA GRAS was only for algae-based DHA, a very specific source," Tsetsis said.

While infant formula supplemented with DHA and AA will be new for U.S. consumers, it's been sold in other countries since 1994. Currently, it's available in preterm infant formulas in more than 60 countries and term formulas in 20.

The enriched formulas will sell for 10 percent to 20 percent more than the standard products. Tsetsis was confident the higher price would not deter consumers. "What manufacturers have seen in Europe is that they put out their premium [fatty acid-enriched] product on the shelf next to the standard product, and the premium is grabbing more of the market share left and right," Tsetsis said.

The FDA approval will have a large impact on consumer awareness of the health benefits of fatty acids, Tsetsis said. "I think we are already starting to see this—a recent [The Early Show] had [Bryant] Gumbel talking about the importance of DHA, and there was a recent Associated Press article; every week there seems to be more."

The next market for the fatty acids will most likely be pregnant women, according to Tsetsis. "The next natural market will be for maternal use in pregnancy and lactation, because women's diets in the U.S. are very deficient in the omega-3s. Pregnant women are not eating foods rich in fatty acids, such as salmon and tuna, eggs, or organ meats. The average person's diet is probably 100 mg lower in DHA content than it was 50 years ago," she said.

Martek is not the only manufacturer pleased with the FDA's decision. Ellin Todd, manager of public relations for Omegatech Inc., a Boulder, Colo.-based manufacturer of DHA, said the FDA approval process has done a tremendous job in raising awareness about the acids. "It was a wonderful announcement. There have been a number of big stories released about this that have raised awareness," she said. She said the FDA's warning to pregnant women about deep-sea fish increased sales, and the approval will probably do the same.

Natural Foods Merchandiser volume XXII/number 9/p. 3, 9