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Date: | Tue, 3 Dec 2002 09:13:36 EST |
Content-Type: | text/plain |
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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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