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Lactation Information and Discussion <[log in to unmask]>
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Tue, 3 Dec 2002 09:13:36 EST
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Thank you Valerie for a wonderful post on the formulas with the DHA/ARA 
additives. I have copied below what NABA has posted on its website, 
(www.naba-breastfeeding.org) regarding these formulas. NABA has received many 
reports of infants who consume these formulas experiencing explosive 
diarrhea. PLEASE report these incidents to the manufacturer and the FDA as 
described below. NABA (Barbara Heiser) just attended the FDA's infant formula 
subcommittee's recent two day meeting in Washington, DC where a number of 
these issues were discussed. I continue to collect reports of the side 
effects of these formulas and am happy to share what information I have.

The marketing of these formulas is extremely deceptive, to the point where we 
have reports of mothers wondering whose breast milk was added to the formula. 
If this was not so sad and tragic it would be laughable that an industry has 
been allowed to dupe parents and health care professionals into thinking that 
fermented microalgae and soil fungus can somehow equal the ingredients found 
in breast milk.

Marsha Walker, RN, IBCLC
Weston, MA

New Infant Formulas with DHA and
                  ARA

                  The recent addition of the long chain polyunsaturated fatty
                  acids DHA and ARA to infant formulas and baby foods may
                  not be safe. The Institute of Medicine is currently
                  undertaking studies on these ingredients for safety. While
                  the FDA has allowed them onto the market, it has not
                  actually approved them for use. The FDA simply raised no
                  questions to Martek Biosciences (the manufacturer of the
                  fatty acids) when it applied for its GRAS status (generally
                  recognized as safe). Since most of the studies and clinical
                  trials of these formulas were conducted on small numbers
                  of subjects (babies), the FDA expects formula companies
                  that use this fatty acid preparation will conduct what is
                  called “postmarket surveillance” for adverse effects. This
                  means that the companies essentially have the 4 million
                  babies born each year in the US as their experimental
                  subjects to feed them these formulas and see what
                  happens. Parents do not know that the formulas have not
                  been FDA approved, are unaware that there may be
                  unknown side effects, and are completely oblivious to the
                  fact that their babies are being experimented on without
                  their informed consent.

                  Parents and most health care providers are also unaware
                  that the DHA is extracted from fermented microalgae and
                  the ARA comes from soil fungus. These ingredients are not
                  part of the normal food chain and have demonstrated side
                  effects in animal testing such as steatorrhea (fat loss in
                  the stool). In fact, NABA has started to receive reports of
                  babies experiencing watery, explosive diarrhea and
                  vomiting from the use of these formulas.

                  Both Mead Johnson and Ross Products Division have
                  engaged in extremely aggressive marketing of these
                  products. There have been a number of reports to NABA
                  describing Mead Johnson salesmen walking onto the
                  maternity unit, removing all of the standard Enfamil
                  formula and replacing it with Lipil (the fatty acid
                  supplemented formula) without the knowledge or
                  permission of ANYONE in the hospital. The salesmen then
                  tell physicians and nursing staff that Mead Johnson does
                  not make Enfamil anymore and that this is what should be
                  used. This is not true and is then followed up with
                  in-services to promote the use of the formula. There is
                  almost no evidence that these formulas pose any
                  advantage to babies over standard formulas and can be as
                  much as 45% more expensive when parents buy them in
                  the store. The advertising to parents has been so
                  misleading that NABA has received reports of mothers
                  asking their health care providers for the “formula with
                  breast milk in it” or the “breast milk formula.”

                  Aggressive marketing pays off. Martek saw sales of its
                  nutritional products increase 183% for the first 9 months 
of
                  2002 over the same period last year. 80% of the revenue
                  was generated from sales of Martek’s oils to formula
                  companies. Mead Johnson’s second quarter earnings in
                  2002 increased 18% over the same period in 2001, which
                  was attributed to their introduction of Lipil.

                  Actions for Breastfeeding Advocates
                  1. report all incidents of diarrhea, vomiting, intolerance,
                  etc in babies who have been given either Lipil or Ross
                  Similac Advance to the FDA MedWatch program as well as
                  to the respective formula manufacturer. www.fda.gov. It is
                  extremely important to do this in order to establish a
                  record of the problem and to help protect babies who
                  cannot protect themselves from relentless assaults on
                  their health

                  2. advise parents that these formulas pose no advantage
                  to their infant and that they are being investigated for
                  safety

                  3. report all marketing excesses to the Federal Trade
                  Commission, www.ftc.gov. This includes any print materials
                  given to parents that state either of these formulas is
                  similar to breast milk or will make the baby as smart as a
                  breastfed infant. This is false and misleading advertising
                  since it causes the consumer to purchase the product
                  thinking that their baby will be more intelligent

                  4. inform your hospital that these formulas are being
                  investigated for safety and are experimental. Ask about
                  the hospital’s liability if the formula is given to the 
baby
                  without the knowledge or consent of the mother. Make
                  sure the following departments are aware of the
                  information in this alert:
                  Corporate Compliance
                  Ethics Committee
                  Risk Management 
                  Pediatric Practice Committee
                  Legal Department

                  

             ***********************************************

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