Toward a Breastfeeding Resiliency Act
Essential Statutory Changes to Protect Mothers and Babies - Could This Be The Answer to Increasing Breastfeeding Rates?
For the past seven years, breastfeeding rates have all but stagnated - that is about to change. The Foundation has just uncovered the mystery that explains why...the law itself: federal statute defines infant formula as a food that is a "simulation" and "substitute for" human milk. Unbelievably, the law asserts an equivalence no one has ever had to prove. That two-word choice is the root of nearly every downstream hurdle breastfeeding has faced since 1980 - the marketing, the hospital practices, the missing leave policies. Correcting it is the lever nothing else has touched. Let’s lift the lid on pandoras box.
The Core Regulatory Asymmetry
U.S. law regulates infant formula and breastmilk on fundamentally unequal terms.
Infant formula has been the subject of repeated congressional action since 1980. Together these actions give formula:
Its own statutory definition (FD&C Act §201(z))
Dedicated FDA regulatory authority
Manufacturing and quality-control standards
Premarket notification requirements
Shortage-reporting mandates
Supply-resilience funding
Formula is one of the few foods in the U.S. with its own dedicated statutory framework.
Breastmilk and breastfeeding have none of this. It is regulated only indirectly, through the generic definition of “food” written in 1938. There is
No statutory definition of human milk,
No statutory definition of breastfeeding as a physiological process,
No dedicated regulatory framework for either
No federal supply-resilience strategy for them.
This is a second, related gap that current law collapses without noticing. Human milk is a substance. Breastfeeding is an act - the physiological process of direct feeding, hormonal regulation, and maternal-infant interaction that produces the milk, delivers it, and generates a separate set of protective effects in the mother. Federal law does not distinguish between the two, and as a result it fails to protect either one on its own terms.
The result is a circular and backwards structure: §201(z) definition:
"Infant formula" means "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk." FDA
The definition uses the words “simulation” and “substitute for” human milk, but the law never defines human milk itself. Congress legally defined the substitute without ever defining the biological system the substitute was built to imitate - something no other major area of health regulation does. Drugs are evaluated against defined disease processes; devices against defined physiological functions; environmental rules against defined endpoints. The Infant Formula Act inverted that logic in 1980, and the inversion has never been corrected.
This asymmetry isn’t just a drafting gap. It has shaped what the regulatory system actually measures. Because human milk is undefined, regulators default to what can be measured in formula:
Protein
Fat
Vitamins and minerals
Growth curves (as opposed to normal human development)
Manufacturing consistency
Formula can satisfy every FDA requirement on this list while never being shown to reproduce the immune, neurological, metabolic, microbiomial, or maternal-child effects associated with breastfeeding. Compliance gets mistaken for equivalence.
Redefining Formula: From “Substitute” to “Manufactured Caloric and Nutritive Product”
The deepest problem with §201(z) is not just that it leaves human milk undefined - it’s that the words it uses for formula, “simulation” and “substitute for,” actively assert an equivalence that the science does not support. Both words invite comparison. Both imply that formula and human milk occupy the same category, differing only in manufacture. Neither claim can currently be verified, because formula is not evaluated against the full range of biological functions human milk performs - only against nutrient content and physical growth.
A corrected definition would need to do the opposite of what §201(z) does now: instead of asserting equivalence, it would need to foreclose the comparison entirely. A workable formulation:
Infant formula is a nutritive caloric product for use when breastfeeding or breastmilk is not possible.
This definition is deliberately restrictive in what it permits:
No use of “substitute.” A substitute implies interchangeability - that one thing can reasonably stand in for another because the two are functionally alike. Formula, evaluated only on nutrients and growth, has never been shown to be functionally alike to human milk across its immune, neurological, metabolic, and microbiomial functions.
No use of “simulate.” Simulation implies formula is attempting to reproduce human milk’s properties. But most of human milk’s bioactive components - antibodies, stem cells, human milk oligosaccharides, extracellular vesicles, live immune cells - cannot currently be manufactured or replicated at all. Calling formula a simulation overstates what it does.
No comparative language of any kind. The definition should not invite a side-by-side evaluation (”as good as,” “similar to,” “comparable to”) because current formula regulation cannot actually support such a claim - it was never required to demonstrate it.
“Manufactured Nutrative, Caloric Product” instead. This is accurate to what regulation actually verifies: formula provides calories and specified nutrients that support some growth. It makes no claim beyond that.
“When breastmilk is not available” and conditional framing. Formula’s role is defined by circumstance - breastfeeding or breastmilk not being possible - rather than positioned as a parallel, equally valid option from the outset.
This single change in definitional language would ripple through the entire regulatory system. Labeling, marketing claims, health messaging, and even hospital discharge practices are all downstream of what the statute says formula is. As long as the statute calls formula a substitute or a simulation, marketing built on those exact words is defensible. Once the statute confines formula to a last-resort caloric alternative, comparative marketing claims lose their statutory foundation.
What a Breastfeeding Resiliency Act Would Actually Change
A Breastfeeding Resiliency Act would not replace or weaken formula regulation. It would apply the same regulatory logic Congress already used for formula - that infant nutrition is too important to leave to generic food law - to the biological system formula was designed to imitate, and it would correct the definitional imbalance described above. Its scope would include:
1. A statutory definition of human milk.
Currently no such definition exists anywhere in federal law. A workable model:
“A biologically active, human-derived developmental system essential to infant growth, immune function, metabolic programming, and maternal-child health, consisting of nutrients and thousands of bioactive components that function together to support human development.”
This creates the reference standard that regulators, and formula manufacturers, would be measured against - something currently impossible, since you cannot assess how well a product approximates an undefined thing.
2. A statutory definition of breastfeeding, separate from human milk itself.
Human milk is the substance; breastfeeding is the act that produces and delivers it. Current law has no definition for either, but conflating them would still leave a gap, because breastfeeding carries functions that the milk alone does not capture. A workable model:
“The physiological process of direct infant feeding from the breast, encompassing the maternal-infant hormonal, immunological, and behavioral interactions that regulate milk production and delivery, support infant neurodevelopment and attachment, and confer protective health effects on the mother.”
Recognizing breastfeeding as its own legal category matters because:
It supports outcomes that pumping or bottle-feeding milk alone does not fully replicate - including maternal-infant attachment, hormonal regulation (oxytocin release, maternal stress reduction), and infant self-regulation of intake.
It protects the mother, not just the infant. Breastfeeding is associated with reduced maternal risk of breast and ovarian cancer, faster postpartum uterine recovery, reduced postpartum hemorrhage, and improved long-term maternal metabolic health. None of this is captured by regulating milk as a substance.
It is the thing actually disrupted by the policy failures the current system ignores - inadequate leave, early separation, and unsupportive workplace or hospital practices interrupt the act, not just the supply of the substance. A framework that protects only milk, and not the feeding relationship itself, would still miss the primary point of failure.
3. A redefinition of formula, as above - replacing “substitute” and “simulate” with “last-resort caloric alternative,” and removing comparative language from the statute entirely. For example:
Infant formula is a manufactured, nutrient-based caloric product for infant feeding, formulated to support physical growth and intended for use as a last resort when direct breastfeeding or human milk is unavailable, insufficient, or medically contraindicated. Infant formula is evaluated according to its measurable nutrient content, manufacturing safety, and growth outcomes, and is not represented, labeled, or marketed as equivalent, comparable, or interchangeable with human milk or breastfeeding.
4. A benchmark broader than growth.
Formula is currently evaluated almost entirely on:
Weight gain
Length
Head circumference
Nutrient content and stability
A Resiliency Act would expand the reference standard used to evaluate human milk itself - and to make clear how much broader its functions are than what formula is required to demonstrate or could possibly do - to include:
Immune development and infectious-disease protection
Microbiome development
Neurological and cognitive outcomes
Metabolic programming (insulin sensitivity, obesity and diabetes risk)
Gastrointestinal and endocrine development
Epigenetic and stress-response programming
Maternal health outcomes (cancer risk, postpartum recovery, hormonal and metabolic health)
5. A federal supply-resilience framework for both human milk and breastfeeding, parallel to the one formula already has.
Formula shortages trigger reporting requirements, supply-chain protections, and manufacturing incentives - the 2022 shortage response is the clearest example. No comparable mechanism exists to monitor or protect the nation’s breastmilk supply, or the conditions that allow breastfeeding itself to occur, even though breastfeeding rates sit well below public health targets and are driven substantially by policy, not biology. A Resiliency Act would establish equivalent monitoring and protective mechanisms for the conditions that determine whether mothers can both produce human milk and engage in the act of breastfeeding - since disruptions to work leave, hospital practice, or workplace accommodation interrupt the feeding relationship even when the physiological capacity to produce milk is intact.
To do that, the Act would need to identify - and protect against - the specific forces that currently interfere with breastfeeding:
Insufficient or unpaid parental leave
Early mother-infant separation
Institutional childcare policies that separate mother and baby
Workplace policies and barriers that discourage or prevent lactation
Hospital practices that interfere with breastfeeding or delay skin-to-skin contact
Insufficient access to skilled breastfeeding support
Inadequate breastfeeding training for healthcare providers
Aggressive or deceptive formula marketing
Misleading health claims in formula marketing
Public messaging that minimizes the differences between breastmilk and formula
These are not incidental obstacles - they are the actual points of failure a Resiliency Act would be designed to correct. Current law protects formula against disruption at every one of these points (supply, marketing standards, manufacturing continuity). No equivalent protection exists for breastfeeding against any of them.
The Critical Infant Feeding Window
Current law treats infant feeding as a series of interchangeable choices made meal by meal, day by day. The underlying biology doesn’t work that way. A substantial body of research points to a critical feeding window - roughly the first hours after birth through the first 6 months (at least) of life - during which what an infant is fed does more than provide nutrition. It programs biological systems that don’t get a second chance to be programmed the same way later.
This window matters because several of the developmental processes tied to early feeding are time-sensitive, not just dose-sensitive:
Immune priming. Early exposure to colostrum and early milk shapes the infant’s initial immune development, including antibody transfer and gut-immune signaling that occurs most intensively in the first days and weeks.
Microbiome colonization. The infant gut microbiome is established in large part during the first weeks of life. Human milk oligosaccharides feed and shape that early colonization in ways later feeding cannot fully retroactively correct.
Metabolic programming. Early nutritional exposure is linked to long-term metabolic “setting” - insulin sensitivity, appetite regulation, and obesity risk - through mechanisms that are most active in early infancy.
Neurological and attachment development. Early skin-to-skin contact, feeding-related hormonal exchange, and maternal-infant interaction in the first hours and days support neurodevelopment and attachment patterns that are difficult to fully replicate once the window has closed.
None of this is currently reflected in law. Formula regulation evaluates growth as a running average over time, and it treats formula and breastmilk as freely interchangeable at any point in an infant’s life. That framing assumes there is no meaningful cost to feeding decisions made in the first hours or days - that whatever happens early can simply be corrected later. The research on the critical window says otherwise.
This gap also explains why some of the policy failures already identified in this framework do disproportionate damage. Hospital practices that delay skin-to-skin contact or introduce formula in the first hours, early mother-infant separation, and the absence of paid leave in the first weeks don’t just create a general inconvenience - they interfere with feeding at precisely the point in development when the interference is hardest to undo. A policy framework that only protects breastfeeding “in general,” without recognizing that the first hours and days carry outsized biological weight, will miss the highest-value point of intervention.
A Breastfeeding Resiliency Act should therefore treat the critical feeding window as a protected period in its own right - not just one more phase of infancy, but the phase where hospital practice, early leave, and skilled lactation support matter most and where current law currently offers the least protection.
Downstream Effects: Putting Breastfeeding in Its Proper Place
Once human milk and breastfeeding are both legally defined, formula is legally confined to a nutritive, caloric product, and the feeding relationship - not just the substance - is treated as a protected system rather than a background assumption, a range of issues currently treated as scattered, separate advocacy causes become expressions of a single coherent legal framework:
Parental leave becomes a protection issue for both milk supply and the feeding relationship itself, not just a workplace-benefits issue - inadequate leave interrupts breastfeeding as an act, the way a factory disruption interrupts formula supply.
Hospital practices and early separation become regulable disruptions to a protected physiological process - the act of breastfeeding, and the maternal-infant interactions it depends on - not just clinical-practice variation.
Formula marketing and health claims lose their statutory basis for comparative language, since the underlying law no longer describes formula as a substitute or simulation for either the milk or the act that produces it.
Lactation support and provider training become part of maintaining a federally recognized system that protects both milk production and the mother’s ability to feed directly, comparable to quality-control infrastructure for formula manufacturing.
Workplace and childcare policy are assessed by their effect on both the nation’s human-milk supply and mothers’ ability to breastfeed, the same way policy affecting formula manufacturers is assessed by its effect on the formula supply.
Maternal health policy gains a basis it currently lacks - breastfeeding’s protective effects on the mother (reduced cancer risk, postpartum recovery, hormonal and metabolic health) become a recognized public-health interest in their own right, not a secondary benefit mentioned only in passing.
The current framework produces a self-reinforcing loop: because breastfeeding is undefined and unprotected, breastfeeding rates stagnate or decline; this increases dependence on formula; increased dependence drives more formula-specific regulation; and each round of formula regulation further cements formula as the de facto center of infant-feeding law, while the biological norm stays legally invisible.
A Breastfeeding Resiliency Act reverses the order of operations. It doesn’t ask “how do we make the substitute safer and more available” - Congress has already answered that question five times since 1980. It asks the question Congress never asked: what is the biological system infant nutrition actually depends on, and what does it take to protect it.
Correcting that foundational omission means recognizing three things: human milk as a substance; breastfeeding as the act and relationship that produces it, delivers it, and protects the mother; and formula as neither a substitute nor a simulation, but a last-resort caloric product. Once that foundation is corrected, every downstream policy area - leave, hospital practice, marketing, workforce training, childcare - can be evaluated within one coherent framework, with breastfeeding restored to its place as the biological norm.