Kendamil is not FDA approved, but that’s true of every infant formula on the market. The FDA does not approve infant formulas. Instead, manufacturers must submit a new infant formula notification before selling in the United States, and the FDA reviews it to confirm the product meets federal nutritional and safety requirements. Kendamil’s regulatory path has been slightly different from domestic brands, and understanding those differences matters if you’re choosing a formula for your baby.
Why No Infant Formula Is “FDA Approved”
The phrase “FDA approved” applies to drugs and certain medical devices, not to infant formula. The FDA’s own website states plainly: “The FDA does not approve infant formulas.” What the agency does is require manufacturers to submit detailed documentation, called a new infant formula submission, before bringing a product to market. This submission covers the formula’s ingredients, nutritional profile, manufacturing processes, and safety testing. The FDA reviews this information to verify the product meets all required nutritional and safety standards.
So when you see a formula on store shelves in the U.S., it hasn’t been “approved” in the way a prescription medication would be. It has been reviewed and permitted for sale. This distinction applies equally to major domestic brands like Similac and Enfamil.
How Kendamil Entered the U.S. Market
Kendamil took a different route into the American market than most formulas. During the 2022 infant formula shortage, the FDA issued emergency guidance allowing certain foreign manufacturers to sell formula in the U.S. under what’s called “enforcement discretion.” This meant the FDA temporarily relaxed some of its usual requirements to get more formula onto shelves quickly. Kendamil, made by UK-based Kendal Nutricare Ltd, was one of the companies that received this permission.
In September 2022, the FDA created a transition plan for these manufacturers. Rather than pulling their products when the shortage eased, companies could continue selling while they worked toward meeting all standard FDA requirements. Kendamil participated in this transition plan with three product lines: Kendamil Classic, Kendamil Organic, and Kendamil Goat.
Where Kendamil Stands Now
Kendal Nutricare submitted its new infant formula notification to the FDA by the expected deadline of July 15, 2025. This is the same type of submission that any domestic formula manufacturer would file before selling a new product. Completing this step moves Kendamil from its temporary enforcement discretion status toward the same regulatory standing as formulas that have been sold in the U.S. for decades.
In practical terms, this means Kendamil is providing the FDA with evidence that its formulas meet U.S. nutritional requirements, manufacturing standards, and labeling rules. For example, FDA regulations require infant formula to contain at least 1 mg of iron per 100 calories. Kendamil’s milk-based formula contains exactly 1 mg of iron per 100 calories, meeting that threshold.
How Kendamil Compares to Domestic Formulas Regulatory-wise
The key difference is history, not safety standards. Brands like Similac and Enfamil have been going through the FDA’s notification process for decades and have long-established relationships with the agency. Kendamil is newer to the U.S. market and is completing that same process now.
It’s worth noting that Kendamil is not a small or untested company globally. It has been manufactured in the UK’s Lake District since the 1960s and is sold across Europe under European Union food safety regulations, which are generally considered comparable to or stricter than U.S. standards in several areas. The company holds certifications from British food safety authorities, and its products comply with EU compositional requirements for infant formula.
What This Means for Parents
If you’re considering Kendamil, the regulatory picture is straightforward. No formula is FDA approved, so that’s not the right benchmark. The relevant questions are whether the product has been reviewed by the FDA, whether it meets U.S. nutritional requirements, and whether the manufacturer is in compliance with FDA oversight. Kendamil has submitted its formal notification, its products meet the required nutrient levels, and the company is actively participating in the FDA’s regulatory framework.
The formula is currently available at major U.S. retailers including Target and Whole Foods. All three lines, Classic, Organic, and Goat, are part of the FDA transition process. If the FDA identifies any issues during its review of Kendamil’s submission, the agency has the authority to require changes or remove the product from the market, the same enforcement power it holds over every formula sold in the country.