The Food and Drug Administration of the United States pays close attention to baby formulas. The FDA requires infant formula to fit into a narrow nutritional profile. The agency has established tough regulations through the Infant Formula Act, which includes nutrient testing, ensuring standard food safety rules and monitoring tests of infant growth, and labelling requirements.
However, an increasing number of parents today seem to think that European infant formula may be a better option. Many American parents look to Europe to purchase formula, even though these formulas are not approved by the FDA. Nonetheless, it is commonly known that higher quality ingredients are used, particularly in the all-organic formula brands.
Holle and HiPP are among the most popular brands. They are two German-based manufacturers of all-organic infant formula that have established a reputation for better quality ingredients, exclusive use of organic foods and guaranteed to be free of GMO, hormones and pesticides. These two brands, among other European organic manufacturers, are already very popular in Europe and increasingly gaining popularity in America. They have many decades of experience in the baby formula and baby food business and have long been trusted by European parents.
Why won’t the FDA approve European-made infant formula in the United States?
European children grow up healthy and strong, so it begs the question of why the FDA won't approve European-made baby formula. The answer is a mix of strict laws and regulations for infant formulas.
The FDA’s nutritional requirements for infant formulas are codified by law. The relevant information can be found in US Title 21: Subchapter B: Part 107: Subpart D. It includes regulations for labelling and nutrient information based on 100-calorie servings of infant formula in specific units. Just as the US, the EU has minimum and maximum nutrient guidelines, but the formulas are differentiated for infants of different age groups. Additionally, the European Union expresses its nutritional regulations in other units of measurement. These units are different than those the FDA uses, so making comparisons requires some conversion math.
The EU establishes more nutrient specifications and limits than the FDA. There are some deviations for a small number of vitamins and minerals where the EU formulas do not meet FDA requirements, but mostly it is the other way around. EU baby formula may not fall within the narrow range of FDA guidelines, but it is for certain that the EU regulations require meeting higher standards.
Parents scramble to buy European baby formula
Parents across the US scramble to find suppliers of European infant formula. The ever-increasing number of those who prefer European brands like Holle, HiPP and Lebenswert feel that the European formulas use higher quality ingredients and meet the nutritional needs of growing infants.
It's especially important to many parents to avoid feeding their children heavily processed foods and added sugars. United States formulations allow synthetic ingredients and ingredients like brown rice syrup, corn syrup, sucrose, and glucose syrup solids.
Criticism on European formulas
In a New York Times article concerning the dangers of importing European baby formula [3], Dr. Steven Abrams made statements that have been heavily disputed by experts throughout the world. Dr. Abrams intimated that it doesn’t really matter what cows eat, and grass-fed cows can be found in the United States infant formula for parents who support organic foods.
Multiple clinical studies and peer-reviewed articles cover the various effects that a cow’s diet has in flavor and the nutritional profile of milk. One of the strongest studies found that grass-fed cows produced milk with more omega-3 unsaturated fatty acids and linoleic acid, which are able to reduce cardiovascular diseases and have some anticancer properties.
The truth, according to a report posted at pickyeaterblog.com, is that so-called organic formulas for infants in the United States often contain organic sugar and soy, a known hormone disruptor [6]. People choose bio European infant formula because it’s not so heavily processed and fully complies with EU organic guidelines, which are very strict and guarantee the absence of hormones, GMOs, pesticides and strictly limit the usage of antibiotics.
Why is it important to choose organic?
Some people wonder whether feeding organic baby formula to infants is really that important. According to the demand of organic formula and baby products from European and American moms, it is definitely!
It is reported that European organic infant formula provides the following benefits:
- Organic infant formula has no synthetic or artificial ingredients.
- Organic infant formula provides healthy and wholesome nutrition.
- Organic infant formula provides expanded feeding options for babies with special dietary needs.
- Organic infant formula is free of GMOs, growth hormones that are problematic for adults and definitely shouldn’t be part of an infant’s diet.
- The ingredients of organic infant formula are produced without pesticides and with strictly limited use of antibiotics for animals.
Ingredients that should be avoided in infant formula
Unfortunately, a lot of ingredients that should not be included in a baby's diet sometimes end up in infant formulas. Adults routinely eat things they shouldn’t, but bad foods can generate serious consequences when fed to babies. Some bad ingredients that wind up in baby formula include:
Soy
This plant protein may be a healthy choice for adults, but it contains high levels of phytoestrogens and should only be used in cases where infants are allergic to lactose or may suffer from a milk protein allergy. European authorities strongly disadvise from feeding soy to infants and it is a standard to not include it in infant formulas (it's only recommended for babies with special needs, such as dairy allergy, and should only be fed under the advise of a doctor).
Sucrose
This form of sugar might make formula tastier, but added sugar can generate hyperactivity, sugar cravings, overeating and infant obesity. It is not allowed in European formulas.
Carrageenan
Used as a thickener, this compound can cause stomach distress and even lead to cancer. This substance has been banned in Europe.
Concluding Insights
In the United States, the Food and Drug Administration regulates meeting the nutritional needs of infants. That includes establishing criteria for nutrient content, providing nutrient quality control, recalling formula when there’s a problem and recordkeeping. The FDA requires all prospective manufacturers of infant formula to submit the details and win approval before selling these products to the public.
Many parents however feel that the standards of the FDA are not sufficient and feel safer using infant formula from Europe. There are companies with decades of experience, such as HiPP and Holle, that produce baby formula according to organic standards. The market is growing as many entrepreneurs, including working mothers, are inspired by these organic infant formula brands and enter the field to manufacture children’s foods and infant formula themselves. Many locate in Germany or other European countries to take advantage of these countries' organic commitment.
Sources
E Schmidt: Do HiPP, Holle and Lebenswert Meet FDA Requirements? (https://medium.com/@santacrz1988/do-hipp-holle-and-lebenswert-meet-fda-nutritional-requirements-781a47f7cf35)
Official Journal of the European Union: Regulation (EU) No 609/2013 of the European Parliament as regards the specific compositional and information requirements for infant formula and follow-on formula (https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32016R0127)
Center for Food Safety and Applied Nutrition: Guidance for Industry - Frequently Asked Questions about FDA's Regulation of Infant Formula (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-frequently-asked-questions-about-fdas-regulation-infant-formula/)
Christina Caron and Jessica Grose: European Baby Formula That Is Illegally Sold in the United States Carries Risks, Pediatricians Warn (https://www.nytimes.com/2020/04/18/parenting/baby/european-formula.html)
Anjali Shah: Are European Baby Formulas Safe To Use? (https://pickyeaterblog.com/are-european-baby-formulas-safe-to-use)
Sally Kuzemchak: Is European Baby Formula Really Better? (https://www.parents.com/recipes/scoop-on-food/is-european-baby-formula-really-better/)
source https://organicsbestshop.com/blogs/organicsbestclub/why-are-european-formulas-not-fda-approved-1
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