As parents, we are as passionately focused on the nourishment and safety of your loved ones as you are. As a company that values transparency, we are committed to maintaining an openness about our products, their scientific integrity, and the standards with which they are created.
Our families have been asking deeper questions about some of the ingredients used in our Organic Infant Formula, which we appreciate. We’d like to explain why we chose to use each of these ingredients when developing this high quality product. Carefully modeled after breast milk, our premium ingredients abide by the strict criteria of the USDA certified organic program to ensure safety and nutritional completeness. These ingredients are important for infant growth and development, and are all either permitted or required by the FDA to be present in infant formula.
Sodium Selenite (Generally Recognized as Safe (GRAS) FDA-2013-N-0067). Selenium is required to be in infant formula per the U.S. Food and Drug Administration (FDA). See this link for more information. The FDA based their requirement for the addition of selenium to infant formula on scientific evidence from multiple sources. In addition, the FDA searched the scientific literature from 1998 through 2012 for published studies not included in the published report 80 FR 35834. See appendix below for references.
Taurine (GRAS self-affirmed). Taurine is a small sulfur-containing ????-amino acid found in most tissues. Human milk concentrations of taurine have been reported in the range of 5.1 to 11.9 mg/100 kcal (34 to 80 mg/L). Cow’s milk contains very low levels. In 1981, supplementation of term infant formula began in Europe based on experimental evidence and clinical features of deficiency in patients who were nourished only with parenteral nutrition without taurine (Sturman & Chesney, 1995). The FDA approved taurine for supplementation in 1984. Since that time, the US infant formula industry has been adding taurine to compensate for the low levels in cow’s milk. The addition of taurine to infant formula was reassessed in 1998 by the Expert Panel of the Life Sciences Research Office’s “Assessment of Nutrient Requirements for Infant Formulas” (Raiten, 1998). It was determined that the addition of taurine was safe up to a maximum level of 12 mg/100 kcal.
Cholecalciferol (GRAS 21 CFR 184.1950). Vitamin D is required to be added to infant formula in the US per FDA Code of Federal Regulations (21 CFR 107.100). The primary function of Vitamin D is used to maintain serum calcium and phosphorus concentrations within a normal physiologic range to support neuromuscular activity, bone mineralization, and biochemical processes within the cell.
Calcium Pantothenate (GRAS 21 CFR 184.1212). Vitamin B5 is required to be included in infant formula per 21 CFR 107.100. The levels required in infant formula are based on the levels found in human breast milk. Humans require Vitamin B5 to synthesize coenzyme-A (CoA), as well as to synthesize and metabolize proteins, carbohydrates and fats.
Ascorbyl palmitate (GRAS 21 CFR 182.3149). Ascorbyl palmitate is an ester formed from ascorbic acid and palmitic acid creating a fat-soluble form of Vitamin C. Vitamin C is required to be included in infant formula per 21 CFR 107.100.
Choline Bitartrate (GRAS 21 CFR182.8250). Choline is required for synthesis of phospholipids, transfer of methyl groups, and synthesis of the neurotransmitter acetylcholine. Functionally, choline serves as an important precursor for the biosynthesis of phosphatidylcholine (PC), the major phospholipid of the brain, liver and other tissues.
Beta carotene (GRAS 21 CFR 184.1245). Beta carotene is a pigment found in plants that give them their color. Beta carotene is present in human milk (Gossage et al., 2002). In humans, beta-carotene converts into vitamin A (retinol). Vitamin A is required to be included in infant formula per 21 CFR 107.100.
Biotin (GRAS 21 CFR 182.8159). Biotin is required to be included in infant formula per 21 CFR 107.100. The levels required in infant formula are based on human breast milk levels. Three biotin-dependent enzymes have been identified in humans: pyruvate carboxylase, required for glucogenesis; acetyl coenzyme A, needed for propionate metabolism; and 3-methyl crotonyl coenzyme A carboxylase, required for the degradation of the amino acid leucine (Mock, 1996).
DI-alpha tocopherol (GRAS 21 CFR 182.8892). Vitamin E is required to be included in infant formula per 21 CFR 107.100. This inclusion is meant to address potential vitamin E deficiency-related issues. Two populations are at particular risk for vitamin E deficiency: preterm, low-birth weight infants and patients with malabsorption of fat. The primary disorders attributed to Vitamin E deficiency are platelet dysfunction, hemolytic anemia and neurological disorders. Deficiency states in infants are also associated with fat absorption disorders, cholestasis and celiac disease. Vitamin E deficiency may also lead to retinal vascular disease. Vitamin E supplementation in the diets of preterm infants is an accepted component of clinical management for the prevention of intracranial hemorrhages, retinal vascular disease and chronic pulmonary disease (Bell, 1989).
Inositol (GRAS 21 CFR 184.1370). Inositol is abundant in many human tissues. In fact, the high inositol levels in human milk and in the developing fetus suggest that fetal and newborn development may represent a period of potential susceptibility to dietary deficiency. The inclusion of inositol in infant formula was reaffirmed by the Expert Panel of the Life Science Research Organization of the American Society of Nutritional Sciences in the report “Assessment of Nutrient Requirements for Infant Formulas.” (Raiten, 1998)
Phytonadione (GRAS self-affirmed). Vitamin K is required to be included in infant formula per 21 CFR 107.100. Vitamin K is important in maintaining normal blood clotting homeostasis.
We know this is a lot of information, but we want you to be aware of the careful research and passionate attention that goes into the development of our Organic Infant Formula. If you should need any more clarification on our Organic Infant Formula ingredients, please call us directly at 1.888.862.8818 — we are always here to help and support you! Thank you.
- The Institute of Medicine’s (IOM) “Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium and Carotenoids” (2000)
- The Life Sciences Research Office’s “Assessment of Nutrient Requirements for Infant Formulas” (Raiten, 1998)
- “Global Standard for the Composition of Infant Formula. Recommendations of an ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology, and Nutrition) Coordinated International Expert Group (Koletzko et al., 2005)
- Selenium Status of Term Infants Fed Selenium-Supplemented Formula in a Randomized Dose Response Trial (Daniels et al., 2008)
- (Sturman & Chesney, 1995)
- (Raiten, 1998)
- (Gossage et al., 2002)
- (Mock, 1996)
- (Bell, 1989)