By Terence Chea Martek Biosciences Corp. said May 17 that the Food and Drug Administration has concluded that its nutritional oils are safe, essentially clearing the way for their sale in infant formula in the United States.
The oils are already sold in infant formula in more than 60 countries. But until now they were not approved for sale in this country, which represents one-third of the $6 billion worldwide market for infant formula.
"We are very optimistic that by the end of the year you'll see products with Martek's oils in the U.S.," said Pete Buzy, the Columbia company's chief financial officer.
Food additives such as Martek's oils require an independent panel of experts to certify that they are "generally recognized as safe," or GRAS, and the FDA must approve their GRAS status. Martek submitted its application for FDA review in February 2000, and yesterday the company said the agency approved the oils' GRAS status after reviewing data from clinical studies.
Martek officials believe FDA clearance of the oils could substantially boost the company's revenue. The company typically receives about 5 percent from the sales of infant formula that contains its oils, which means it could generate as much as $100 million annually in the $2 billion US market.
Martek has licensed its oils to four major formula manufacturers, including Wyeth-Ayerst Nutritionals, Mead Johnson Nutritionals and Abbott Laboratories, which represent about 60 percent of the world's formula production. The manufacturers must separately gain regulatory approval to add the oils to their US products.
Officials at Wyeth-Ayerst and Mead Johnson, which together sell more than 80 percent of the infant formula sold in this country, would not comment directly on their plans to sell formula with Martek's oils in the United States.
Martek's oils, Dhasco and Arasco, contain two fatty acids that are naturally present in breast milk but not added to most infant formulas.
Scientific studies have found that the oils boost an infant's intelligence and vision, and several international health organizations have endorsed their use.
Infant formula with Martek's oils typically cost about 15 percent more than regular formula, but Martek officials believe most parents are willing to pay for its long-term nutritional benefits.
"Parents are willing to pay a little more for better nutrition for their kids," Buzy said. "Having these fatty acids for the first year of life will give you immeasurable benefit in terms of IQ and vision for the rest of your life."
Washington Post Friday, May 18, 2001; Page E05
There is good news and bad news with the above story. The good news is that the DHA formula will be an improvement for most who are not , as DHA is an essential part of brain development.
It is important to remember that approximately 60 percent of the human brain is composed of fatty material 25 percent of that material is DHA.
Although DHA is essential, if it is given out of balance, without EPA, as in the form being suggested by the FDA, it is potentially problematic.
When DHA is given, it should be balanced with its cousin, EPA.
This works out quite nicely as the processing to isolate DHA is quite expensive. So an excellent brand of fish oil would provide both of these essential fatty acids.
There is another caution here, though. It is important not to fall into the American trap of 'if a little is good, than more is better.' If one supplements infants (or adults) with large amounts of EPA/DHA, serious imbalances can occur, which will actually make you less healthy.
The simple and inexpensive form of supplementation that I am currently recommending is cod liver oil. One of the best ones I know of is from Carlson's. It is a liquid and the child would only need about ¼ teaspoon for the first few months and then ½ teaspoon after that.
This would be FAR less expensive and a FAR healthier option than using the DHA supplemented formula that will apparently be available in the US in the near future.
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