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Subject:
From:
Ina Bransome <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Wed, 10 May 2023 09:20:23 -0400
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Dr Hope Lima gave a talk on supplementation, on various types of formulas.
She is a Ph.D. in biochem, is a registered dietician and an IBCLC.
www.hopefeedsbabies.com

This is from my notes on her talk which was part of a bundle on the
complexities of supplementation hosted by Annie Frisbie IBCLC of
www.paperlesslactation.com:

Formulas are not approved by FDA the way drugs are. In other words, they
are not tested before being marketed to see that babies do indeed grow on
these formulas.

FDA is attesting that the micro and macro nutrient levels are as stated on
the label in every can or bottle - as labelled so long as the formula
bottles are prepared according to the manufacturer’s instructions.

Labels say - if properly prepared - the formula will contain not less than
the minimum and not more than the maximum of the following nutrients for a
human of a certain age.

in creating a new formula, manufacturers have to give an explanation of why
it’s needed to the FDA. They have to alert the FDA. They don’t have to wait
for approval from the FDA. As long as the proposed new product's list of
ingredients falls within the guidelines for formulas for infant feeding,
meaning the table of nutrients and their minimum allowable and maximum
allowable amounts. They also have to attest that they will not market it
unless it meets “quality factors."  Those were not clearly explained as I
recall.

I recall learning elsewhere that formulas for infant feeding generally bear
the GRAS rating from the FDA which means: Generally Regarded as Safe, a
rating used for food additives, not for food itself.


--
Ina Bransome, IBCLC
Int'l Board Certified Lactation Consultant
www.inabransome.com
www.rockawaybaby.com

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