Formula Updates

Healthy Babies Happy Moms’ own Kathy Moren, RN IBCLC attended a conference sponsored by South County Hospital in Rhode Island, called "Supplement with Care." One of the speakers was Marsha Walker, an RN and IBCLC who is an extremely well-known international speaker and the author of numerous publications including those on the hazards of formula use. Walker is also the executive director of the National Alliance for Breastfeeding Advocacy: Research, Education and Legal Branch (NABA REAL), and as such, advocates for breastfeeding on the Massachusetts state and federal levels. One of her lectures addressed the addition of ARA and DHA to infant formulas. This topic was of particular interest to Kathy, as she is frequently asked by clients about her opinion on the new "smart" formulas.

Walker's lecture included an educated opinion on the subject, which Happy Babies, Healthy Moms would like to pass along so that you can form your own opinion, and make an informed decision.

You may be aware of the new formulas on the market that claim to make your baby smarter and see better. These formulas are given out in hospitals as a part of formula companies’ “gift packs,” and are sold in all retail stores at a cost that is 15-30% more expensive than regular formula with iron. The new formulas contain ARA and DHA, compounds that are also present in breast milk. They are long-chain polyunsaturated fatty acids and are essential to an infant’s healthy, functioning nervous system. The difference is that the ARA and DHA in breast milk is a human fatty acid that is structurally different from those manufactured by plant sources. When added to infant formula, ARA and DHA "may act differently in the body than human ARA and DHA, depending on where and in what proportion they are found and the source they are derived from." (NABA, Abreast of Our Times, Winter 2003).

Of particular concern is where these additives come from: the DHA is extracted from fermented micro algae (cryptecodiunium cohnii) and the ARA is from soil fungus (mortierelle alpina). They are manufactured together by Martek BioSciences under the name Formulaid. These sources may potentially leave infants exposed to environmental contaminants as well as toxins from the fungal sources that could act as an opportunistic pathogen in an infant with a compromised immune system.

Many side effects have been reported by mothers using these formulas. NABA has received numerous complaints of babies experiencing watery explosive diarrhea, diaper rash, excessive foul smelling gas and abdominal cramping. Some general concerns that were expressed by Marsha Walker were that supplementation with the highly unsaturated oils increases the susceptibility of the cell membrane to oxidant damage and disrupts the antioxidant system (Song, 2000 & 2001), increases insulin activity (Pan, 1994), has a possible effect on gene transcription (Clarke, 1996) and may contribute to the obesity epidemic (Massiera, 2003). Walker also points out the many flaws in the research presented to support the use of these additives. Her review of the literature found no studies indicating that this addition to formula is necessary, nor do they demonstrate an advantage of using these formulas instead of breast milk.

The sample size of the studies that have been done are very small (50-60 babies) in light of the millions of babies using these formulas. The studies have high attrition (dropout) rates with no explanation, so that all that's left in the study are babies who are tolerating the formula without any problems. Additionally, the long term effects are not yet known. No long term follow up has been completed as no baby using this formula has reached adulthood. Yet, they claim enhanced visual acuity and cognitive ability into adult life.

So, in light of all this information, how do these formulas get FDA approval and placement in the marketplace? First of all, infant formulas and the additives are classified as a food, and not a drug; therefore, they are not subject to the same level of scrutiny. The FDA states “the law does not require that the FDA approve infant formulas but instead requires companies to provide certain information to the FDA before they market new infant formulas. Manufacturers must provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. If such assurances are not provided, the FDA will object to the manufacturer’s marketing of formulas; however the manufacturer may market the formula over the FDA’s objection.”

Secondly, the FDA does not give approval for these additives. Instead, the makers of these additives must notify the FDA that they feel these items are “Generally Regarded as Safe," or GRAS. The makers conduct their own research and draw their own conclusions as to the safety of the additive, and forward that to the FDA. The FDA does not carry out its own investigation. The FDA states “that any evaluation that the use of a food ingredient is safe is a time dependent judgment based on general scientific knowledge and for this reason it expects infant formula manufacturers that use these ingredients to conduct scientific and rigorous post-market surveillance to monitor babies that consume these products.”

It appears that babies who use these formulas are doing so without their parents’ informed consent. These babies are then supposed to be studied after the fact to determine the safety of these formulas, yet no known studies are taking place. The only data regarding the side effects of these formulas are complaints provided to NABA and the FDA from parents and MDs whose infants have experienced illness as a result of using them.

So, what is a parent to do? Obviously, Healthy Babies, Happy Moms recommends that you exclusively breastfeed your baby for the first year of his or her life. But if you must use formula – and we do realize that many people need to – use formula that has been on the market for years and is one of the basic infant formulas with iron. We would not use anything “new and improved,” or with any kind of additive until it has been on the market for years and researched thoroughly by objective professionals. It is also recommended that you report any side effect of formula use to your baby’s doctor, the FDA, NABA and the formula maker.

Some websites to help you file a report and find out more information are listed below. Many of these websites and/or documents were used as references for this webpage.

A Link in the Chain: From Oil Refinement to Baby Formula
Replacing Mother: Infant Formula Report from the Cornucopia Institute
The Cornucopia Institute’s Adverse Reaction Reporting Form
MedWatch Online Voluntary Reporting Form