Breastfeeding 1-2-3 » FDA

Push for Regulation of Infant Formula

Angela White, J.D., breastfeeding counselor — Tue, 11 Aug 2009 05:15:26 +0000

In response to a call for ways in which the Food and Drug Administration (FDA) could advance the health needs of children, the United States Breastfeeding Committee submitted a letter detailing its concerns with the safety and efficacy of infant formula. In summary, the Committee seeks:

1. Adequate testing of new ingredients prior to their addition to infant formula and updated FDA review and approval procedures for those ingredients.
2. Close monitoring for adverse reactions to the products and a public report of those reactions.
3. Review and any necessary repudiation of the health claims made in the marketing of formula.
4. Advice to consumers that formula is not sterile, poses dangers due to contamination, and must be properly prepared.

Newborn baby in father's hands by Michelle Bergkamp

Frankly I think it’s incredible that those provisions are not already in place, given that for many (too many!) babies, formula is all they consume for the first six months of life. Those tiny and vulnerable babies — if they are not going to receive breast milk — at least must be assured the safest possible breast milk substitute.

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Study Results on Infant Feeding Practices

Angela White, J.D., breastfeeding counselor — Mon, 06 Oct 2008 07:02:27 +0000

Over 2,000 mothers were studied from the third trimester of pregnancy through the first year of their infants’ lives. The U.S. Food and Drug Administration (FDA) in conjunction with the Centers for Disease Control and Prevention (CDC) surveyed the mothers about their infant feeding practices. Results from this Infant Feeding Practices Study II will be available publicly from the CDC at the end of 2008, but in the meantime the American Academy of Pediatrics reports:

Among the study findings were that one-fourth of mothers do not place their child on their backs to sleep, as recommended by the American Academy of Pediatrics, and 34 percent regularly co-slept with their infants. In addition, only 8 percent of mothers experienced six “baby-friendly” hospital practices that encourage and assist mothers with breastfeeding. The more of these practices experienced, the greater the likelihood that mothers would breastfeed for six weeks or longer. Pertaining to food practices, nearly all mothers who fed their infants formula used an iron-fortified product, and more than 20 percent of infants had a food-related health problem, including 6 percent with allergies.

It is not at all surprising to me that mothers are not receiving proper encouragement and assistance in hospitals for breastfeeding. Those findings are consistent with the 2007 CDC National Survey of Maternity Practices in Infant Nutrition and Care, which found that 70 percent of birth facilities continue to undermine breastfeeding by marketing formula to new mothers.

Those findings are also consistent with my experience when I prepared to give birth this past July. I researched Baby-Friendly Hospitals and did not find any in my area. When I examined the breastfeeding rates in the hospitals near me, they were disappointingly low. I was glad to have a home birth and a successful start to breastfeeding.

Hopefully the results of the Infant Feeding Practices Study II will inspire additional practice-specific research and lead to greater support for breastfeeding.

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FDA Warning about Mommy’s Bliss Nipple Cream

Angela White, J.D., breastfeeding counselor — Sat, 24 May 2008 22:54:17 +0000

Yesterday the U.S. Food and Drug Administration issued a warning against the use of Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, Inc. to nursing mothers for treatment of cracked and sore nipples. The packaging specifically states that it is not necessary to remove the cream before nursing, but two ingredients in the cream may be harmful to nursing infants. The FDA describes the dangers of chlorphenesin and phenoxyethanol:

Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers should discontinue use of the product and watch for the following signs of infant distress (and seek immediate medical assistance for any of these symptoms):

~ decrease in an infant’s appetite
~ difficulty in awakening the child
~ limpness of extremities
~ decrease in an infant’s strength of grip
~ a change in skin color.

Mothers using the cream may suffer from dermatitis as well.

The FDA says consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency’s voluntary reporting program, by e-mail at www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Thanks to Marijke at the new b5media pregnancy blog, Womb Within, for the information on this story!

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FDA’s Breast Pump Website

Angela White, J.D., breastfeeding counselor — Fri, 30 Mar 2007 15:57:39 +0000

Need help safely choosing and using a breast pump? Check out the new breast pump website launched by the the U.S. Food and Drug Administration. Breast pumps are considered medical devices and thus the FDA regulates them. As part of an initiative with the U.S. Breastfeeding Committee the FDA put together this site to offer breast pump basics. It answers important questions like: