|
Products
Services
Breastfeeding References
Monthly Newsletter
Sign up for our free newsletter and get the latest information on breastfeeding, child care and child development delivered right to your email box.
|
|
Formula Updates
This past September I attended a fascinating conference sponsored by South County Hospital in Rhode Island. The conference was called "Supplement with Care" and one of the speakers was Marsha Walker. Marsha is a RN and IBCLC who is an extremely well known international speaker and the author of numerous publications including ones on the hazards of formula use. Marsha 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 state (MA) and federal level. One of her lectures addressed the addition of ARA and DHA to infant formulas. This topic was of particular interest to me, as I am frequently asked by my clients what my opinion is of these new "smart" formulas. Marsha's lecture helped me to form what I think is an educated opinion on the subject. I'd like to pass that information along to you, so that you can form an educated opinion yourself, and then use that information to make informed decisions for your family.
I am sure that you are all aware of the new formulas on the market that claim to make your baby smarter and see better. These formulas are all given out in the hospitals in the formula company gift packs and sold in all retail stores at a cost that is 15-30% more expensive than regular formula with iron. These 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 a healthy functioning infant 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 form." (NABA Abreast of Our Times, Winter 2003) Of particular concern to me, 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) and they are manufactured together by Martek BioSciences under the name Formulaid. These sources leave the baby who uses this formula potentially exposed to environmental contaminants as well as toxins from the fungal sources that could act as an opportunistic pathogen in a babe with a compromised immune system.
There are many side effects that 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). She also pointed 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 rather than 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 why, so that all that's left in the study are babies who are tolerating the formula without any problems. In addition, the long term effects are not known. No long term follow up has been completed yet, 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 out 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 scrutiny that drugs are. 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 conclusion 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 parent’s 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, I recommend that you exclusively breastfeed your baby for the first year of its life. But if you must use formula, and I 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. Similac, Enfamil, SMA, Carnation are the ones that immediately come to mind. I 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. I would also report any side effect of any formula use to your baby’s doctor, the FDA, NABA and the formula maker as well. 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 web page.
www.FDA.gov
www.naba-bresatfeeding.org
http://www.naba-breastfeeding.org/news.htm#DHAARA
http://www.cfsan.fda.gov/~dms/qa-inf22.html
http://www.cfsan.fda.gov/~rbd/opa-g007.html
http://www.cfsan.fda.gov/~rbd/opa-g080.html
http://www.cfsan.fda.gov/~rbd/opa-g041.html
http://www.cfsan.fda.gov/~dms/qa-inf20.html
http://www.cfsan.fda.gov/~dms/qa-inf17.html
http://www.cfsan.fda.gov/~dms/qa-inf19.html
http://www.ars.usda.gov/is/AR/archive/dec02/oil1202.htm
|
|
|
|
|
