Formula-containing discharge bags are one of the most brilliant means of
marketing a product that has come along. This is so effective that marketing
text books include formula bags as an example of how to market a product!
These bags are usually part of a contract with the hospital which stipulates
that the bags be given to breastfeeding mothers in exchange for cash grants
to the hospital, trinkets, equipment, etc. They have been very effective in
peddling the new fatty-acid supplemented formulas to the extent that many of
these contracts are now using only Lipil or Similac Advance in their
discharge bags and will only provide those formulas free to the hospital,
even though the regular formulas are still available. It doesn't seem to
matter to hospitals, physicians, and nurses that these new formulas are
causing side effects in babies. Some so serious that they require
rehospitalization.

Well, help may be on the way. The Federal Government now defines these
discharge bags as MARKETING. No one can pretend any longer that they have any
value, that they are given because they are cute, or that the mothers want
them. If a hospital gives these away they are engaging in marketing-pure and
simple. The definition of marketing in this respect comes from the HIPAA
Privacy Rule (Health Insurance Portability and Accountability Act contained
in the Code of Federal Regulations as 45 CFR 164.501, 164.508(a)(3)).
Marketing is defined as making a communication about a product or service
that encourages recipients of the communication to purchase or use the
product or service. The rule exempts formula bags from prior authorization
but still states that a free package of formula constitutes marketing.

The rule also states that hospitals or other entities (such as physician
offices) may not sell names of pregnant women to baby formula manufacturers
or magazines without an authorization. The complete discussion about
marketing can be found at: www.hhs.gov/ocr/hipaa/guidelines/marketing.pdf.
While the Code is not legislated in the US, there are bits and pieces
scattered throughout policies and laws that may be relevant to our work.
Corporate compliance officers may benefit from a copy of this document.

I am always sad and disappointed when I hear nurses and physicians defending
the formula salesmen, and demonstrating how easily they believe whatever the
last salesman pitched, rather than evidence-based information.

The FDA has the means for us to report problems with infant formula. Go to
www.cfsan.fda.gov/~dms/ds-inf.html. Please report all problems with these new
formulas to the FDA and to the respective manufacturer.

Marsha Walker, RN, IBCLC
Weston, MA

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