Formula for a Scam

"He has his mother's brains" proclaims Martek Biosciences Corp.'s new ad featuring an infant staring at a computer monitor and fingering the keyboard.

The message is that smart babies come from smart mothers — those who feed their babies formula supplemented with DHA (docosahexaenoic acid) and AA (arachidonic acid), apparently magical nutritional oils manufactured by Martek.

The U.S. Food and Drug Administration green-lighted last July the use of DHA and AA in baby formula. Ross Products (maker of Similac brand formula) and Mead Johnson (maker of Enfamil brand formula) are getting ready to launch their supplemented formulas in early 2002.

Don't be fooled. There's no demonstrable reason for parents to pay a 20 percent premium for these dubious potions.

DHA and AA are polyunsaturated fatty acids present in human milk. Some researchers have hypothesized DHA and AA play roles in early neurological and visual development.

This belief is based on the correlation of two observations: Blood levels of DHA and AA are higher in breast-fed infants as compared to formula-fed infants and some studies report  developmental test scores of breast-fed children are slightly higher than those of formula-fed children.

Mere correlation, though, is a far cry from proving cause and effect.

There is no firm scientific evidence that DHA and AA are essential or beneficial to infant development. So differences in blood levels of DHA are of unknown, and perhaps even no significance.

Assuming for the sake of argument that breast-fed infants actually fare better on developmental tests than formula-fed infants, this could be explained by many factors.

Women who choose to breast-feed tend to be older, more educated and of higher socio-economic status than those who don't. These key factors could easily account for the slight developmental differences reported in some — but not all — studies comparing breast-fed with formula-fed infants.

Moreover, the long-term benefits of DHA/AA supplementation — that is, in later childhood, adolescence and adulthood — can't even be guessed. No studies have followed children beyond the age of two years.

The irony in the rush to sell enhanced formulas is rich.

A study published last August in the medical journal Pediatrics reported no differences in development between infants fed supplemented formula and those fed regular formula. Who sponsored and conducted the research? Ross Products.

No doubt all this is why experts at the American Council on Science and Health, including the former chairman of the American Academy of Pediatrics Committee on Nutrition, concluded in a recent report that, "the addition of DHA and AA to infant formulas is not warranted at this time."

So if there's no persuasive evidence that enhanced formula will be more beneficial than regular formula, why did the FDA approve the use of DHA and AA?

The FDA's shocking attitude seems to be: "What could it hurt? But don't blame us if it does."

Martek petitioned the FDA five years ago to permit supplemented formula. The FDA approved the petition last summer, seemingly granting DHA and AA the special status of "generally recognized as safe." GRAS status means a food additive isn't expected to cause harm in normal use.

The FDA approval letter stated it had "no questions at this time regarding Martek's conclusion" that DHA and AA are GRAS. The FDA added, "The agency has not, however, made its own determination regarding the GRAS status …"

Did you get that? The FDA didn't pass its own judgment on safety; it relied on Martek's decision-making.

Covering its bureaucratic rear end, the FDA added, "it is the continuing responsibility of Martek to ensure that food ingredients that the firm markets are safe." The FDA will also place a similar burden on formula manufacturers.

This mandatory post-market surveillance of infant formula is unprecedented and means that infants will be guinea pigs.

The FDA's Web site says, "Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way."

Hmmm …

Not only is it uncertain whether DHA and AA will provide any benefits to infants whose parents certainly will pay a premium for supplemented formula, but the FDA won't even risk proclaiming the substances safe.

And parents are supposed to feed this stuff to their newborns?

Steven Milloy is the publisher of, an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).