Bioactive Formula Ingredients

What are “Bioactive” Formula Ingredients

Formula can contain extra ingredients called “bioactive” ingredients. Such formulas are more expensive and are marketed as better for infant visual and brain development among other benefits. Companies are currently required to have data on hand that substantiates the claims put on their labels, but they are under no obligation to share the data with the FDA or the public. This may sway even families with limited budgets to spend more money for unclear benefit. What are these ingredients and do they really benefit your baby?

Want more information about formula feeding? Check out these articles: Paced Feeding, Recommended Upright Bottle Feeding, Formula Fats and Micronutrients

DHA and ARA

According to the FDA, the scientific evidence on the benefits of DHA and ARA are mixed, some showing positive effects and some showing no benefit. There are no published reports that demonstrate long-term benefits. Therefore, the FDA does not currently require formula to contain DHA and ARA. The European Union, however, required that all formula contain DHA, but not ARA, after February 2020.

Two of these components are fatty acids called arachidonic acid (ARA) and docosahexaenoic acid (DHA), which are found in breast milk at low concentrations. According to a review, “ARA plays an important role in physiological development and its related functions during early life nutrition,” and “DHA is essential for the proper functioning of the retina in both preterm and term infants.”

Both DHA and ARA are known to accumulate in the brain and eye of the fetus in the third trimester of pregnancy; which means infants who are born premature may miss out on this transfer of these fatty acids. Both of these fatty acids are produced by the body from other essential fatty acids provided by breast milk or formula.

However, research has shown that the synthesis of ARA and DHA from these essential fatty acids are limited in the fetus and newborn due to premature enzyme activity. Therefore DHA and ARA have been included in some formula given the data on term and premature infants that show they may improve brain development and visual acuity.

The manufacturers argue that adding preformed DHA and ARA along with the fatty acids that help an infant make its own DHA and ARA to infant formula may be beneficial. According to the FDA, the scientific evidence on the benefits of adding DHA and ARA are mixed, some showing positive effects and some showing no benefit.

Several prominent pediatricians have written strongly worded commentaries in prominent medical journals including Dr. Michael Landa, retired Director of US FDA Center for Food Safety and Applied Nutrition as well as Dr. Steven Abrams, Chair of the AAP Committee on Nutrition of the American Academy of Pediatrics, criticizing current trends in marketing of infant formulas that claim their ingredients “foster cognitive health” or “supports digestive health,” which include formulas containing DHA, ARA, prebiotics, probiotics, lactoferrin, and Bovine Milk Fat Globule Membrane.

Most studies on these ingredients are industry sponsored and the findings are often weak or inconclusive. Dr. Landa and Dr. Abrams have noted that the FDA released draft guidelines regarding the quality of evidence that formula manufacturers should be required to have to substantiate such claims, including randomized clinical trials. Yet the current evidence available to the public for such ingredients does not meet the proposed FDA standards.

According to Dr. Landa and colleagues, the available data are limited by “small sample sizes, poor follow-up, and unpersuasive results.” In an email correspondence with Dr. Steven Abrams, he states that he “is not convinced that these new ingredients have been adequately studied, especially over the long term.” He states that “most studies in this area are funded by the formula industry, which raises the concerns for bias, and makes the case for more federal funding of infant nutrition research.” For instance, a Cochrane systematic review examining 15 studies assessing the benefits of DHA and ARA, including 11 that tracked neurodevelopmental outcomes, did not find any benefit to supplementation.

Learn more about formula feeding in these articles: How do formula fed babies obtain antibodies?, Preparing Multiple Bottles of Formula, The Stigmatization of Formula Feeding

A2 Formula

In 2020, formula manufacturers released A2 formula. A1 and A2 refer to the type of beta-casein protein in milk. Human milk contains A2 and cow’s milk contains mostly A1. A2 milk is marketed as easier to digest and closer to breast milk. A 2017 systematic review found only one study showing A1 consumption was associated with slower digestion and two studies associating it with looser stool consistency.[18] Ultimately, the review concluded that more data needs to be collected on the health claims of A2 formula manufacturers.

W-PHF formula

Some formulas contain 100% partially hydrolyzed whey protein (W-PHF), which are marketed to be easier on the stomach and may reduce the risk of atopic dermatitis (or eczema). However, the FDA reviewed these claims and concluded that there was “little to very little evidence…to support a qualified health claim [19].”

Low-Lactose, Prebiotics, Probiotics, Lactoferrin, MFGM

Low-lactose formula is marketed as “sensitive” and formula with prebiotics is marketed as “supportive of the immune system” despite a lack of long-term data and scientific consensus on their benefits. The same goes for probiotics (marketed as good for gut health), bovine lactoferrin (marketed as important for immune health), and bovine milk fat globule membranes (marketed as good for brain development).

Take Home Points

There are consequences to these unregulated claims. Families may spend more money on formula without gaining any additional health benefits for their infants. Inflated prices also reduce the reach of critical federal nutrition programs like WIC. According to Dr. Landa and his colleagues, “The US Department of Agriculture (USDA) estimated that more than $91 million of the approximately $850 million spent on infant formula by WIC was attributable to the higher price because of ingredients bearing these claims.”

What should you get out of this? Additional ingredients like DHA, ARA, probiotics, prebiotics, and others are available in many infant formulas, and given current evidence, it is unclear whether they provide any long-term advantages over formula without these ingredients. It is ultimately your choice what formula to purchase. But if cost is an issue and buying a higher cost formula that contains these other ingredients results in not being able to afford your baby’s full nutritional requirement, it is better to buy a lower cost formula and provide their full requirement to ensure healthy growth. There is far more robust data showing that simply meeting your child’s full nutritional needs—through a sufficient amount of any commercial formula—is the essential ingredient for optimal infant health and brain development.

We believe Fed Is Best. Learn more about safe and effective infant feeding in these articles: Early Introduction of Bottles for Breastfed Babies, Fed is Best Safe Newborn Feeding Guidelines, Ensuring Sufficient Newborn Feeding in the First Days

To learn more about this topic, read the Fed Is Best book available on paperback, e-book, and audiobook.

Order Book

References

1. Center for Food Safety and Applied Nutrition, “Questions & Answers for Consumers Concerning Infant Formula,” FDA, March 3, 2021, https://www.fda.gov/food/people-risk-foodborne-illness/questions-answers-consumers-concerning-infant-formula.

2. “Food for Infants and Young Children,” accessed August 16, 2021, https://ec.europa.eu/food/safety/labelling-and-nutrition/specific-groups/food-infants-and-young-children_en.

3. Camilia R. Martin, Pei-Ra Ling, and George L. Blackburn, “Review of Infant Feeding: Key Features of Breast Milk and Infant Formula,” Nutrients 8, no. 5 (May 11, 2016): E279, https://doi.org/10.3390/nu8050279.

4. Renata Pietrzak-Fiećko and Anna M. Kamelska-Sadowska, “The Comparison of Nutritional Value of Human Milk with Other Mammals’ Milk,” Nutrients 12, no. 5 (May 14, 2020): E1404, https://doi.org/10.3390/nu12051404.

5. E. E. Birch et al., “Visual Acuity and the Essentiality of Docosahexaenoic Acid and Arachidonic Acid in the Diet of Term Infants,” Pediatric Research 44, no. 2 (August 1998): 201–9, https://doi.org/10.1203/00006450-199808000-00011.

6. Eileen E. Birch et al., “Visual Acuity and Cognitive Outcomes at 4 Years of Age in a Double-Blind, Randomized Trial of Long-Chain Polyunsaturated Fatty Acid-Supplemented Infant Formula,” Early Human Development 83, no. 5 (May 2007): 279–84, https://doi.org/10.1016/j.earlhumdev.2006.11.003.

7. Ann Hellström et al., “Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial,” JAMA Pediatrics 175, no. 4 (April 1, 2021): 359–67, https://doi.org/10.1001/jamapediatrics.2020.5653.

8. Center for Food Safety and Applied Nutrition, “Questions & Answers for Consumers Concerning Infant Formula,” FDA, March 3, 2021, https://www.fda.gov/food/people-risk-foodborne-illness/questions-answers-consumers-concerning-infant-formula.

9. “Food for Infants and Young Children,” accessed August 16, 2021, https://ec.europa.eu/food/safety/labelling-and-nutrition/specific-groups/food-infants-and-young-children_en.

10. Helen K. Hughes, Michael M. Landa, and Joshua M. Sharfstein, “Marketing Claims for Infant Formula: The Need for Evidence,” JAMA Pediatrics 171, no. 2 (February 1, 2017): 105–6, https://doi.org/10.1001/jamapediatrics.2016.3837.

11. Abrams, Steven A. “Is It Time to Put a Moratorium on New Infant Formulas That Are Not Adequately Investigated?” The Journal of Pediatrics 166, no. 3 (March 2015): 756–60. https://doi.org/10.1016/j.jpeds.2014.11.003

12. Center for Food Safety and Applied Nutrition, “Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” U.S. Food and Drug Administration (FDA, February 3, 2020), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-substantiation-structurefunction-claims-made-infant-formula-labels-and.

13. 2. Simmer K, Patole SK, Rao SC. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2011,

doi: 10.1002/14651858.CD000376.pub4

14. Brooke-Taylor , Simon et al., “Systematic Review of the Gastrointestinal Effects of A1 Compared with A2 β-Casein,” Advances in Nutrition 8, no. 5 (September 1, 2017): 739–48, https://doi.org/10.3945/an.116.013953.

15. Ca Chung, Carolyn S., Sedigheh Yamini, and Paula R. Trumbo. “FDA’s Health Claim Review: Whey-Protein Partially Hydrolyzed Infant Formula and Atopic Dermatitis.” Pediatrics 130, no. 2 (August 2012): e408-414. https://doi.org/10.1542/peds.2012-0333

16. Agata Skórka et al., “Infant Formulae Supplemented with Prebiotics: Are They Better than Unsupplemented Formulae? An Updated Systematic Review,” The British Journal of Nutrition 119, no. 7 (April 2018): 810–25, https://doi.org/10.1017/S0007114518000120.

17. A. Skórka et al., “To Add or Not to Add Probiotics to Infant Formulae? An Updated Systematic Review,” Beneficial Microbes 8, no. 5 (October 13, 2017): 717–25, https://doi.org/10.3920/BM2016.0233.

18. William H. Johnston et al., “Growth and Tolerance of Formula with Lactoferrin in Infants through One Year of Age: Double-Blind, Randomized, Controlled Trial,” BMC Pediatrics 15 (November 7, 2015): 173, https://doi.org/10.1186/s12887-015-0488-3.

19. Niklas Timby et al., “Supplementation of Infant Formula with Bovine Milk Fat Globule Membranes,” Advances in Nutrition (Bethesda, Md.) 8, no. 2 (March 2017): 351–55, https://doi.org/10.3945/an.116.014142.

Register

Log in

Registration