Almost every parent we speak with says a version of the same thing: “If this formula was so dangerous, how was it in the NICU? Doesn’t the FDA approve it?” It is a completely reasonable assumption. The formula came from a hospital, it had a well-known brand name on the label, and no one at the bedside suggested it was anything other than standard, government-vetted care. So the idea that a cow’s-milk-based formula could carry an under-warned risk of necrotizing enterocolitis (NEC) feels like it can’t be right.
But the premise itself is where the confusion starts. The FDA does not approve infant formula before it goes on the market — not the kind you buy at the store, and not the specialized preterm formula fed through a feeding tube in the NICU. Understanding what the FDA actually does (and does not do) clears up one of the most common misunderstandings in this litigation, and it explains why an FDA-regulated product can still be the subject of a lawsuit.
The one-paragraph version. The FDA regulates infant formula, but it does not approve it the way it approves a prescription drug. Manufacturers must send the FDA a premarket notification and meet federal nutrient, quality, and labeling rules — but the agency does not run its own trials or issue a safety sign-off before formula reaches babies. Preterm formulas like Similac Special Care and Enfamil’s premature products are “exempt infant formula,” a special category for low-birth-weight and medically fragile infants. None of that answers the question at the center of the NEC lawsuits: whether families and doctors were adequately warned about the NEC risk of cow’s-milk-based formula in premature babies.
Is preterm baby formula FDA-approved?
No. The FDA does not approve any infant formula — standard or specialized — before it can be sold or used. The agency states this plainly in its own consumer guidance: “No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.” That single sentence contains the whole distinction that trips families up: regulated, yes; approved, no.
Instead of an approval process, U.S. law uses a premarket notification system. Under section 412 of the federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C. § 350a), a manufacturer must submit information to the FDA before marketing a new or reformulated infant formula — describing the formulation, the nutrient content, and the manufacturing and quality assurances. The FDA reviews that submission and can act if the product falls short of the requirements. What it does not do is independently test each product for every possible risk and then issue a “safe” verdict before the formula reaches an infant.
What is an “exempt infant formula”?
The preterm formulas at the center of the NEC lawsuits belong to a specific regulatory category called exempt infant formula. An exempt infant formula is one that is represented and labeled for use by an infant who has an inborn error of metabolism, a low birth weight, or who otherwise has an unusual medical or dietary problem. Premature babies fall into this group because they are low-birth-weight infants with heightened nutritional needs, which is why hospital preterm formulas are formulated with extra calories, protein, and minerals.
Exempt infant formula
Formula labeled for infants with low birth weight or an unusual medical or dietary need. Section 412(h) of the Act exempts these products from some of the requirements that apply to ordinary retail formula.
Prescribed, not on the shelf
Exempt preterm formulas are generally not sold on retail shelves. They are ordered by physicians and distributed to hospitals, clinics, and institutions — which is why most families first encounter them in the NICU.
Similac & Enfamil preterm lines
Abbott’s Similac Special Care and Mead Johnson’s Enfamil premature products are the cow’s-milk-based preterm formulas most often named in NEC cases.
Being “exempt” does not mean unregulated. Manufacturers of exempt infant formulas still have to make submissions to the FDA under the agency’s regulations (21 CFR Part 107) and follow quality-control and good-manufacturing-practice standards. What the exemption changes is that these specialized products are relieved of certain requirements — under sections 412(a), (b), and (c) of the Act — that are designed for the general infant population, because an exempt formula is meant for a narrow, medically defined group rather than for every baby. Which brand and product line your baby received is a threshold fact in any case, and we walk through how to pin it down in our guide to which cow’s-milk formula your premature baby was given.
What the FDA checks — and what it does not
The clearest way to see the gap between “regulated” and “approved” is to line up what the FDA’s infant-formula framework actually covers against what parents often assume it covers.
| What the FDA framework does address | What it does not do |
|---|---|
| Requires manufacturers to meet federal nutrient requirements (minimum and, for some nutrients, maximum levels). | Does not run its own premarket clinical trials on each formula. |
| Requires a premarket notification before a new or reformulated formula is marketed. | Does not issue a drug-style approval or safety sign-off before the product is used. |
| Sets quality-control and manufacturing (GMP) standards and can inspect facilities. | Does not certify that a given product will not increase the risk of a disease such as NEC in preemies. |
| Regulates labeling content and requires notification of a formula that is adulterated or misbranded. | Does not write the product’s risk warnings for the manufacturer or guarantee they are adequate. |
The right-hand column is the important one for families. The NEC question — whether cow’s-milk-based formula raises the risk of necrotizing enterocolitis in premature infants — is a scientific and medical question that the FDA’s formula-notification process was never built to answer. The research on that link comes from decades of pediatric and neonatology studies, which we summarize in the science linking cow’s-milk formula to NEC. The regulatory paperwork and the medical evidence are two different things.
Why “the FDA allowed it” is not the same as “the FDA found it safe from NEC”
This is the sentence worth reading twice. When a product is on the market with the FDA’s regulatory framework in the background, it is easy to hear that as a government endorsement of safety for every purpose. But “the FDA permits this formula to be sold” and “the FDA has studied this formula and confirmed it does not increase NEC risk in premature babies” are entirely different statements. Only the first one is true — and even that one describes a notification process, not an approval.
That gap matters because the whole premise of the NEC lawsuits is not that the formulas were illegal, unregulated, or counterfeit. They were lawful, brand-name products used in good faith by NICUs across the country. The claim is narrower and different: it is a failure-to-warn claim — that the manufacturers understood, or should have understood, the association between their cow’s-milk-based products and NEC in premature infants, and did not adequately warn families and the medical community about it. Whether a product was FDA-regulated does not, on its own, decide whether it carried an adequate warning.
How this connects to the NEC baby formula lawsuits
“One of the first misconceptions I clear up for a family is the idea that FDA regulation ends the conversation,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “It doesn’t. These cases have never been about whether the formula was legal to sell — it was. They’re about warnings. The question a jury looks at is whether the company knew enough about the NEC risk to tell parents and doctors, and whether the label and the information given to the medical community reflected that. FDA notification simply isn’t the same thing as a warning about NEC, and the law recognizes that difference.”
Because these are warning claims rather than “was it regulated” claims, the analysis often turns on what the company communicated and to whom — including doctrines about warnings that flow through the physician. We unpack one of those doctrines, and how an appeals court treated it, in our explainer on the learned intermediary doctrine and an NEC verdict that was reversed on appeal.
“When I review a file, the regulatory label on the product isn’t what tells the story — the records are,” says Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert. “I want to see which cow’s-milk-based product was ordered, when it was started relative to the baby’s gestational age, and what the feeding orders and progress notes actually say. A product being an FDA-regulated exempt infant formula tells me nothing about whether this specific premature baby should have been exposed to it, or whether the family was ever told about the NEC risk. The medicine and the documentation answer that — not the regulatory category.”
This is general information, not legal or medical advice. Infant formula regulation is complex, and how any product’s regulatory status interacts with a legal claim depends on the specific facts and records of each case. Nothing here diagnoses any child, evaluates any product, or predicts the outcome of any matter. Past results do not guarantee future outcomes; every case is evaluated on its own facts.
How The Alvarez Law Firm approaches a NEC family’s case
When we review a potential NEC formula case, the regulatory category of the product is not the starting point — the records are. We gather the NICU records that establish the NEC diagnosis and its severity, confirm which cow’s-milk-based formula or fortifier was used and when, and check the eligibility basics, including how premature the baby was. Our team, led by Board Certified Civil Trial Lawyer Alex Alvarez and supported by Medical-Legal Expert Herb Borroto, M.D., J.D., handles that record-gathering so families can stay focused on their child.
Free, confidential case review. No fees unless we recover compensation for you.
- The science behind the claim: the evidence linking cow’s-milk formula to NEC.
- “My baby was breastfed”: cow’s-milk human milk fortifier and the exposure families miss.
- Identify the product: which cow’s-milk formula was your baby given?
- See if your family qualifies: Do I qualify for an NEC lawsuit?
Frequently asked questions
Is preterm baby formula FDA-approved?
No. The FDA does not approve any infant formula before it is marketed, including the specialized formulas used for premature babies in the NICU. Manufacturers must send the FDA a premarket notification and meet federal nutrient and quality requirements, but there is no FDA safety approval the way there is for a prescription drug. In the FDA’s own words: “No, FDA does not approve infant formulas before they can be marketed.”
What is an “exempt infant formula”?
An exempt infant formula is a formula represented and labeled for use by an infant who has an inborn error of metabolism, a low birth weight, or another unusual medical or dietary problem. The preterm formulas fed in the NICU — such as Similac Special Care and Enfamil’s premature products — are exempt infant formulas because premature babies are low-birth-weight infants. Section 412(h) of the federal Food, Drug, and Cosmetic Act exempts these products from certain requirements that apply to standard, retail infant formula.
Does the FDA test infant formula for whether it causes NEC?
No. The FDA’s infant formula requirements focus on nutrient content, manufacturing quality, and labeling — not on whether a particular product increases the risk of a disease like necrotizing enterocolitis in premature infants. The FDA does not run its own clinical trials on formula before it reaches the market. “The FDA allowed this product to be sold” is not the same statement as “the FDA studied this product and found it safe from NEC for preemies.”
If the formula was FDA-regulated, can a family still sue over NEC?
Yes. The NEC baby formula lawsuits are not claims that the products were illegal or unregulated. They are failure-to-warn claims — the argument that the manufacturers knew, or should have known, of the association between cow’s-milk-based formula and NEC in premature infants and did not adequately warn families and the medical community. FDA regulation of a product does not, by itself, resolve whether the product carried an adequate warning.
Sources
- U.S. Food & Drug Administration — “Questions & Answers for Consumers Concerning Infant Formula” (FDA does not approve infant formula before marketing; formulas must meet federal nutrient requirements; manufacturers must notify FDA before marketing). fda.gov
- U.S. Food & Drug Administration — “Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula” (premarket notification under section 412; definition and treatment of exempt infant formula). fda.gov
- U.S. Food & Drug Administration — “Regulations and Information on the Manufacture and Distribution of Infant Formula” (exempt infant formula definition; distribution to hospitals, clinics, and institutions by prescription). fda.gov
- Federal Food, Drug, and Cosmetic Act — Section 412, “Requirements for Infant Formulas” (21 U.S.C. § 350a), including the section 412(h) exemption for exempt infant formula. govinfo.gov
- Code of Federal Regulations — 21 CFR Part 107, “Infant Formula” (labeling, exempt infant formula, and quality-control provisions). ecfr.gov