Best practices in: infant feeding.
The AAP official Policy Statement on Breastfeeding and the Use of Human Milk states that medical contraindications to breastfeeding are rare, but do include infants with metabolic diseases and mothers who are positive for human T-cell lymphotrophic virus type I or II, HIV, or untreated brucellosis. Additional maternal contraindications include mothers with active untreated tuberculosis, those with lesions on the breast from active herpes simplex, and most cases in which the mother is narcotic dependent. There are also a number of cautions regarding maternal alcohol use, smoking, and medication use.
Experts recognize that not every woman will breastfeed, often because of lifestyle issues and/or medical reasons. The AAP and the pediatric medical community agree that infant formula is a safe, science-supported, nutritious means to nourish babies. When parents cannot breastfeed, I try to decrease the guilt factor when talking with them. Infant formulas today are excellent, so I am supportive of that choice.
Store Brands and Advertised Brands
Perrigo Nutritionals is one of four infant formula manufacturers in the United States and the leading producer of store brands (see Insert). The other three companies manufacture nationally advertised brands: Enfamil, Similac, and Gerber. All infant formulas sold in the United States, both store brands and advertised brands, meet the same US Food and Drug Administration (FDA) requirements. Store brand formulas are nutritionally comparable to name brands but cost less because they are not heavily advertised or offered as samples to thousands of hospitals across the country. The savings are passed along to consumers.
For more information, visit www.storebrandformula.com/medical.
FDA Regulation of Formula
The FDA regulations are very clear that formulas sold as store brands and nationally advertised brands meet the same standards. The FDA states on its web site: "All infant formulas marketed in the United States must meet the nutrient specifications listed in FDA regulations." (2)
In addition, "FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall." (3)
Parents and health care professionals can be assured that all infant formulas available in the United States are safe, nutritious, and support normal infant growth and development.
There is such a large selection of formulas available that it is important to help parents understand the differences and demystify the process of formula selection. Many parents feel they must select the most expensive formula so their baby will have the best. The fact is that many formulas are nutritionally comparable despite the shiny labels and marketing campaigns that entice consumers to pick one formula over another.
Consider that formula has three basic components: caloric density, carbohydrate source, and protein composition. An AAP statement states that soy formulas are indicated for congenital lactase deficiency and galactosemia, but there is not enough evidence to recommend them for colic. (4) Although antireflux formulas can be effective at reducing regurgitation, most infants with reflux do not require these types of formulas nor pharmacologic treatment.
In addition to the type or source of protein, another important compositional difference between formulas is whether the protein is intact, or predigested. The majority of infants will do fine on a whole cow's milk protein formula, but for the rare infants who do have true cow's milk protein allergy, there are formulas that contain individual amino acids. Again, the AAP does not recommend soy protein in this instance. (4)
The Problem of Infant Formula Dilution
It is extremely important for pediatricians to advise parents to review the preparation instructions on the formula label. Formula is expensive and it only goes so far, so some parents consider diluting it. This is dangerous because the infant will not consume enough calories. Infants need appropriate nutrients because their growth in the first year is critical for the brain and overall skeletal structure. How quickly the brain grows is directly proportional to how well the brain is going to function. Consequently, the neurodevelopmental outcome is affected if nutrition is not optimal.
Is Switching Formula Safe?
What if an infant has been fed a national brand formula but the parents want to switch to a store brand? Perrigo conducted a study that shows this is safe and effective. In a blinded study, researchers switched 67 infants from a brand formula to a store brand formula, a different brand formula, or the exact same formula packaged differently. (5) Each infant was observed during a 4-day interval followed by a 3-day transitional period to the new formula and for an additional 4-day observation. Caregivers documented tolerance variables (spit, burp, gas, crying, and irritability) throughout all study intervals. Tolerance was comparable when infants were switched from the advertised brands to store brand formulas.
The saying that "breast is best" is absolutely true. Fortunately, in 2014 the science of infant formula is scientifically advanced. All infant formulas, both the advertised brands and store brands, provide nutritionally complete nourishment that is highly regulated by the FDA. Perrigo's studies show a rate of tolerance similar to those of national formula brands, which can give pediatricians and other health care professionals as well as parents more confidence in choosing store brand formulas to meet infant nutritional needs.
(1.) Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012;129(3):e827-e84l.
(2.) Questions & Answers for Consumers Concerning Infant Formula http://www.fda.gov/Food/ FoodborneIllnessContaminants/PeopleAtRisk/ucml08079-htm#7. Accessed August 12, 2014.
(3.) FDA Takes Final Step on Infant Formula Protections http://www.fda.gov/downloads/ForConsumers/ ConsumerUpdates/UCM400238.pdf. Published June 2014. Accessed August 12, 2014.
(4.) Bhatia J, Greer F; American Academy of Pediatrics Committee on Nutrition. Use of soy protein-based formulas in infant feeding. Pediatrics. 2008;121(5):1062-1068.
(5.) The Study of Formula Switching for Infants, www.storebrandformula.com/switching-baby-formula.aspx. Accessed August 12, 2014.
A supplement to Pediatric News[R].
This supplement was sponsored by Perrigo Nutritionals.
Perrigo Formula Information
All studies conducted by Perrigo establish that store brand formulas:
* Provide complete nutrition comparable to the nutrition of advertised brands.
* Are clinically proven to be as well tolerated as nationally advertised brands.
* Are clinically proven to support growth and development.
* Meet the nutritional and quality standards established by the FDA.
* Cost up to 50 percent less than nationally advertised brands.
Perrigo Nutritionals store brand infant formulas are produced in FDA inspected facilities in strict compliance with current good manufacturing practices (cGMP). The company operates two cGMP facilities in Vermont and Ohio that have been producing powdered infant formula for more than 30 years. Perrigo is also approved by Quality Assurance International to manufacture organic formula that is compliant with comprehensive USDA organic regulations.
Perrigo conducts approximately 20,000 tests per month to meet numerous infant formula safety and quality requirement. Store brand formulas:
* Meet the nutritional requirements of the Federal Food, Drug, and Cosmetic Act for infant formula under the regulation of the FDA.
* Meet the nutritional levels recommended by the American Academy of Pediatrics.
* Are certified Kosher by the Orthodox Union.
* Are fully compliant with the Safe Quality Food Program, which certifies that a supplier's food safety and quality management systems comply with international and domestic food safety regulations.