Infant formula **is** regulated in the United States, but as a **food.**
The requirements for making and marketing a food item that is "generally
recognized as safe," or GRAS (a regulatory term) is less stringent than for
making and marketing medications. Both food and drugs are regulated by the
sensibly-named U. S. Food & Drug Administration.

Two links below, to pages at the FDA, show how infant formula is
regulated.  One page is meant for industry, the other for parents.

Once a formula has been FDA-approved using GRAS standards, much of the
regulatory framework has to do with maintaining the basic nutritional
elements and quality of manufacture for that product.

Formula canNOT be substantively changed from the regulatory standard, but
tweaks and adjustments are allowed. So all of that heavy marketing we see
about formulas with "new and improved" recipes are, as I like to call it,
battles between companies over whose sprinkles are better on top of the
cupcake.  Everyone has to make the same cupcake.

Industry page:
https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-information

Parent page:
https://www.fda.gov/food/people-risk-foodborne-illness/food-safety-infants-toddlers

-- 
Liz Brooks, JD, IBCLC, FILCA
Wyndmoor, PA, USA
Private practice IBCLC, speaker, author, educator, lactation advocate
LizBrooksIBCLC.com    @LizBrooksIBCLC

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