FDA to Conduct Follow-up Research to Infant Feeding Practices Study II
The U.S. Food and Drug Administration (FDA) is planning a follow-up survey with mothers who took part in the Infant Feeding Practices Study II (IFPS II). The goal is to increase the agency’s understanding of factors associated with child health and development, including relationships between infant feeding practices and diet quality, food allergy, overweight and obesity.
The IFPS II follow-up survey will assess many factors, including: the child’s consumption of various food groups; the mother's control over the child's eating patterns; the child's physical activity and time spent watching a television or computer screen; the child's sleep patterns; the number of the child's recent physician visits; the number of various types of infections the child had in the past year; whether the child has various health conditions including digestive problems, eczema, food allergy, respiratory allergy; the child's family medical history; the mother's pregnancies subsequent to the sample child and whether subsequent children were breastfed, and employment conditions.
The number of participants is estimated to be about 2,562, with approximately 1,538 respondents, plus 522 mothers are expected to participate through a phone interview. The data will be analyzed and released in a series of publications. To read more about the IFPS II, please click here.
Connecticut Is First State to Ban Infant Formula Packaging Containing BPA
On October 1, 2011, Connecticut became the first state in the nation to ban infant formula packaging containing Bisphenol-A (BPA). Two other states, Vermont and Maryland, have passed laws banning BPA in infant formula packaging, but Connecticut’s is the first law to go into effect.
The U.S. FDA and the regulatory and health authorities of numerous other countries have consistently stated there is no health risk associated with the trace amounts of BPA that potentially can be detected in infant formula or its packaging. Recently, the U.S. Environmental Protection Agency (EPA) upheld the safety through a study summarized in the Research Updates section of this newsletter. Nevertheless, states continue to ban products, including infant formula packaging containing BPA, in response to media reports and consumer concern. U.S. Senator Diane Feinstein, California, recently reiterated her desire for a federal ban.
"Dose" Is Key to Determining Human Risk
In the online journal Nature, FDA scientists Ronald J. Lorentzen and David G. Hattan wrote about the penchant to discount the detail of “dose” when making a case against the safety of a substance. The scientists said “Virtually every situation or substance is hazardous under some conditions, or at some dose, and to refer to hazard (detection) alone paints a profoundly deficient portrait of risk to the public. What matters is how large the risk is---the probability of harm---to the public...”
For example, a report about BPA released in September by the Breast Cancer Fund (BCF) said that BPA levels found in canned foods marketed to children “are of great concern.” Canned foods that BCF analyzed showed BPA had leaked into the food in amounts from 10 to 148 parts per billion (ppb). According to Julie Gunlock writing for the National Review Online, BCF neglected to explain that 148 ppb is not high, when compared to the European Union standard of 600 ppb that was set as the daily limit of safe consumption for BPA. She said the report also failed to mention the many other studies that have shown BPA to be safe.
FDA’s Lorentzen and Hattan concluded “…too much emphasis is placed by almost everyone outside the regulatory community upon identifying hazard, while the much more difficult task of accurately determining the truly important parameter regarding public health, namely human risk, is given short shrift.”
Codex Standard for Follow-Up Formula to be Discussed at CCNFSDU Session
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) will meet November 14-18, 2011 in Germany to address a number of nutrition issues affecting infants and young children. One of the items to be discussed is the possible revision of the Codex Standard for Follow-up Formula (FUF), which has been raised due to international diversification of standards for FUF and the emergence in some countries of growing up milks.
Issues to be considered with regard to the Standard, which were presented in a discussion document by the delegation from New Zealand, include the definition of FUF, the scope of the standard, compositional requirements for FUF, and labeling requirements. The New Zealand background document can be found here. As noted in the proposed timeline for completion of work, if it proceeds, the estimated date of adoption of a revised standard would be July 2016.
WHO Combats Malnutrition with New Web Tool
In early August, the World Health Organization (WHO) launched a web-based initiative to aid healthcare providers and governments in the battle against malnutrition. Called the WHO e-Library of Evidence for Nutrition Actions (eLENA), the new tool offers the latest information on success against under-nutrition, vitamin and mineral deficiencies, and overweight and obesity, which are the three main forms of malnutrition.
According to the WHO, the combination of childhood underweight, micronutrient deficiencies (iron, vitamin A and zinc) and poor breastfeeding are responsible for seven percent of deaths (3.9 million lives lost) and 10 percent of the global disease burden.
"To create eLENA, we have sifted through thousands of pages of scientific evidence and advice to prioritize, justify and better present the kinds of nutrition actions needed to prevent people succumbing to the many forms of malnutrition," said Dr. Francesco Branca, WHO director of nutrition for health and environment.
AOAC SPIFAN Project Update
The AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) met September 18-20 in New Orleans to continue its work on improving nutrient methodologies for infant formula and adult nutritionals. On September 18, Standard Method Performance Requirements (SMPRs) were adopted for Vitamin E, Nucleotides and Ultra Trace Minerals (i.e., Selenium, Chromium, Molybdenum). In addition, work was launched to develop SMPRs for Carnitine, Iodine, and Pantothenic Acid.
On September 20-21, an Expert Review Panel (ERP) approved Official First Action methods for Vitamin E, Nucleotides, Ultra Trace Minerals and Inositol, raising the total of First Action Methods from this project to 15. (First Action methods have already been approved for Vitamin A, Vitamin D, Vitamin B12 and Folate.) All First Action methods are currently undergoing Single Laboratory Validation (SLV) testing using SPIFAN sample matrices, which were manufactured by four of the seven participating companies: Abbott Nutrition; Danone Baby Nutrition; Mead Johnson Nutrition; Fonterra Cooperative Group; Nestlé Research Center; PBM Products; A Perrigo Company; and Pfizer Nutrition.
The ERP will evaluate available SLV data at its next meeting in early 2012, and one method per nutrient will be chosen to be collaboratively studied and presented to Codex as a recommended dispute resolution method.
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CDC Report Says Hospitals Must Do More to Help Moms Breastfeed
The Centers for Disease Control and Prevention (CDC) August 1 Vital Signs report, Hospital Support for Breastfeeding, which is available on the CDC website, says the majority of U.S. hospitals do not fully support breastfeeding. According to the report, “Hospitals should do more to help mothers start and continue breastfeeding. Hospitals that wait to start the first breastfeed, or separate babies from mothers, or routinely give formula to breastfeeding babies make it harder for mothers and babies to be able to breastfeed.”
The report makes recommendations for hospitals to improve certain practices to increase breastfeeding rates. To view an IFC backgrounder on this issue, click here.
U.S. Government Study Casts Significant Doubts Over Bisphenol-A Threat
A recent study funded by the U.S. EPA and carried out by scientists from the Pacific Northwest National laboratory, the U.S. FDA and the CDC has found that even when a typical diet was altered to ensure that high concentrations of the chemical bisphenol-A (BPA) were ingested, the concentration of BPA in blood was below the level of detection.
The study monitored BPA blood concentration levels of 20 adult volunteers who were given a diet 21 percent higher in BPA than that of the average American adult. The findings showed that even though subjects ingested a higher amount of BPA, the BPA levels in 86 percent of blood samples were still much lower than those believed to cause adverse health effects. To view the entire study as published in the Oxford Journal of Toxicological Sciences, click here.
Study Shows Moms Who Don’t Breastfeed Need Support and Formula Education
A recent qualitative study titled, “Women’s perceptions of their healthcare experience when they choose not to breastfeed,” published in Women and Birth, explored healthcare experiences of moms who did not breastfeed. Seven women were interviewed about their infant feeding experience approximately four months after giving birth. The study found five unmet needs in those women: equity, self-sufficiency, support, education, and the need not to feel pressured.
The researchers concluded, “in keeping with the Code of Ethics for Nurses and Midwives, the identified needs of women who do not breastfeed must be addressed in a caring, compassionate and just manner. The care and education of women who formula feed should be of the highest standard possible, even if the choice not to breastfeed is not the preferred choice of healthcare professionals.”
The study also reported “mothers want to be taught and be given the information they need, but they feel that they are not receiving it….there are adverse consequences if women are not supported, and educated in their choice not to breastfeed.” Click here to view the abstract.
Recent Study Shows Fortified Infant Formula Benefits Brain and Heart
A recent study, published in the October 2011 issue of Pediatric Research, suggested that infant formulas enriched with long chain polyunsaturated fatty acids (LCPUFA), such as docosahexaenoic acid (DHA) and arachidonic acid (ARA), benefit developing brains and hearts. This research supports growing evidence that these nutritional compounds enhance brain and behavioral development.
In the first randomized clinical trial of postnatal supplementation to measure attention, 122 term infants were fed one of four formulas from birth to 12 months. Three of the formulas contained varying levels of DHA and ARA, while the other formula contained no DHA or ARA.
Tested at four, six and nine months, the babies’ heart rates and visual attentiveness were measured while viewing images of adult faces. The researchers found the infants fed formulas that contained DHA/ARA to be more cognitively advanced with lower heart rates than the infants given formula without LCPUFA. The formula with the lowest level (0.3 percent) of LCPUFA also produced these benefits.
DHA is an essential LCPUFA affecting brain and eye development that babies develop from their mothers before birth and up to age two. ARA is another LCPUFA that is present in breast milk and commercial formula.
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Comments from Pediatrician Lillian Beard, M.D., to be Regular Newsletter Column
A new, regular column called Ask The Expert will begin with this issue. The column will feature Dr. Lillian M. Beard and her answers to common infant feeding and nutrition questions. Dr. Beard, a Fellow of the American Academy of Pediatrics, is a practicing pediatrician in Silver Spring, Maryland. She also is an Associate Clinical Professor of Pediatrics at the George Washington University School of Medicine and Health Sciences, Assistant Professor at the Howard University College of Medicine, and a communications consultant to industries on issues relating to the care, health and safety of infants, children and adolescents. In addition, Dr. Beard is author of the celebrated book, “Salt In Your Sock And Other Tried-And-True Home Remedies”.
Supplementing Breast Milk with Infant Formula
Q: I have just returned to work after a three-month maternity leave and want to continue breastfeeding my daughter, which has been relatively easy until now. Even though I’m pumping during the day, I can’t produce enough breast milk anymore. I know some women supplement with infant formula. How will that affect my baby and my ability to keep breastfeeding?
A: Congratulations on your commitment to continue breastfeeding. You are among the growing number of breastfeeding mothers of infants in the work force.
Many moms do supplement their breast milk with infant formula, which is the only safe alternative to breast milk. Mixed or supplementary feeding (a combination of breastfeeding and formula feeding) works well for most babies. Also, it is perfectly safe to offer breast milk at some feedings and formula at others. Infant formula provides similar caloric, protein, carbohydrate and fat value as breast milk.
To begin the process of incorporating formula into your baby’s feedings, first decide how often you would like to supplement breastfeeding with formula. Some moms begin by feeding their baby formula once a day. Additionally, you will need to express your milk for the same amount of time your baby would nurse to keep your breasts from becoming engorged and uncomfortable, and to keep your milk supply intact.
Your daughter’s pediatrician will monitor her growth and development with you. You can always go to your pediatrician with questions about infant feeding.
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