The FDA requires that iron levels in infant formula fall within 0.15 - 3mg per 100 kcal. Most European formulas meet this broad reference range, however, in instances where iron is less than 1mg per 100kcal, the FDA requires a statement on the label indicating that additional iron may be necessary. This is particularly important for premature infants or babies with special iron requirements. Many European formulas have iron levels that fall slightly below 1mg per 100 kcal, and because these formulas are intended for European babies only, and meet the requirements set forth by the European Commission for European formula, they, of course, do not have such a label. Hence, the recall.
Discrepancies in iron and labeling requirements, however, are not the only reason to be careful about illegally imported European formula! Many European formulas do not contain English mixing instructions. As you can imagine, this can be a problem as even minor errors in formula concentrations can have serious implications in younger babies. Also, it’s important to be mindful about how formula is transported and stored by third party vendors as nutritional value can be lost more rapidly when stored at higher temperatures. To learn more about the differences between US and European formula, we highly recommend reading this study put forth by NASPGHAN which eloquently compares labeling, nutrition and safety concerns about illegally imported formula.
If you are using illegally imported European formula, we recommend considering a European formula that is either FDA registered and approved in the US (such as Kabrita!) or using a formula that is made in the USA for distribution in the USA. Taking these measures will ensure that the formula you choose meets the labeling, nutrient and safety requirements set forth by the FDA. This also ensures a higher level of accessibility to your formula of choice, especially as the FDA continues to crack down on illegal imports.
Kabrita Goat Milk Toddler Formula* is FDA registered, legally imported from Europe, meets strict guidelines set forth by the European Commission for European formula and also contains 2mg of iron per 100 Kcal as recommended by the FDA!