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FDA Statement on Reported Health Problems With Remedia-Brand Kosher Soy-Based Infant Formula

T03-73
November 10, 2003

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA is aware of reports by Israeli health officials that infants may have been injured by the use of Remedia soy-based infant formula—a product reportedly made in Germany and exported to Israel. The preliminary report issued by the Israeli Ministry of Health states that the Remedia soy-based formula was deficient in the essential vitamin thiamine. Thiamine deficiency results in a condition known as beri-beri which can result in a variety of cardiac and neurological problems, and, if untreated, death.

FDA has determined that no commercial entries were distributed in the United States. It is possible that non-commercial quantities of the product have been brought in by travelers or through the mails.

FDA is working with other health agencies such as the City of New York Department of Health and Mental Hygiene to look into this matter. Anyone who may have Remedia soy-based formula should not use the product and contact their pediatrician as well as the local U.S. Food and Drug Administration office or the agency’s Emergency Operations number, 301-443-1240. FDA will collect the product for testing in our laboratories.

FDA would like the public to be aware of the following information issued by the Israeli Ministry of Health:Preliminary report - An outbreak of beri-beri in Israel due to a lack of thiamine in a soy-based infant formula. November 8, 2003.

On Thursday, November 6, a cluster of four cases of encephalopathy in infants aged 2 months to 9 months hospitalized in the PEDIATRIC INTENSIVE CARE UNIT PCIUin Schneider's Children Hospital in Israel, were reported to the Ministry of Health. The clinical signs reported by the parents were: constipation, agitation, apathy, vomiting, lack of appetite, and later on, diarrhea, grunting, nystagmus, convulsions and unconsciousness.

An investigation by the public health authorities revealed that the one common denominator was that all were fed, almost exclusively, a soy-based infant formula "Remedia Soy Formula", produced by Humana (Germany) and imported to Israel by the company Remedia. A subsequent investigation yielded a further three cases, all being fed the same soy-based formula. The soy-based infant formula was taken to the Public Health laboratories for examination for infectious agents, toxins, heavy metals and thiamine levels. On Friday, November 8, the Ministry of Health issued an alert to the public, advising them to immediately cease using this specific formula. The cans were removed from the shelves in all stores and all sales of the product were halted. Following this alert, more cases were reported including three infants who died two to three weeks ago, two of them with cardiomyopathy.

The working hypothesis at this time was beri-beri, due to a lack of thiamine in the diet. On Sunday, November 8, the results of laboratory tests confirmed that the Remedia soy based formula did not contain any thiamine. The Ministry of Health has advised parents of all infants who had been fed this formula during the last two months, to report to their pediatricians to receive a prescription for two weeks of thiamine supplementation.

To date, 17 cases, including three deaths, have been reported.

Dorit Nitzan Kaluski MD, MPH, RD - Director, Food and Nutrition Administration, Israel Ministry of Health. Manfred S Green MD, PhD - Director, Israel Center for Disease Control.

Rep. Carolyn Maloney (NY-14)
Introduces Federal Breastfeeding Legislation and
Releases Two New Congressional Reports on Breastfeeding

Rep. Carolyn B. Maloney (NY-14) introduced H.R. 2790, the Breastfeeding Promotion Act, on July 18, 2003, with twelve bipartisan original cosponsors. Her legislation amends the Civil Rights Act of 1964 to protect breastfeeding by new mothers, provides for a performance standard for breast pumps, and provides tax incentives to encourage breastfeeding.

To bolster the already substantial evidence that breastfeeding improves the health of both mother and child, Rep. Maloney released today two reports by the Congressional Research Service (CRS): Breast-feeding: Impact on Health, Employment and Society and Summary of State Breastfeeding Laws.
CRS noted in the report that “The health benefits to the infant include the high nutritional quality of human milk, and a decrease in various infectious and other diseases of infancy. Mothers seem to benefit with a more rapid return to the prepregnancy state of their bodies, improved glucose and lipid metabolism, delayed ovulation, and the possible reduction of certain cancers. Proponents of workplace lactation programs cite their benefits to employers as reduced employee absenteeism, increased productivity, increased company loyalty and morale, lower health care costs, and improved employee retention.” [CRS RL32002]

Additionally, CRS found in their research that, “In recent years, there has been an expansion in the practice of breastfeeding. As a consequence of this growing trend, 34 states have enacted legislation associated with breastfeeding. The laws vary considerably in their scope and in their coverage.” [CRS RL31633]

Rep. Maloney states that while the patchwork of state laws are laudable, overall federal protection is needed.

BACKGROUND:

Congresswoman Maloney first passed breastfeeding legislation in the 106th Congress when her Right to Breastfeed language was passed as part of the FY 2001 budget, ensuring a woman's right to breastfeed her child on any portion of Federal property where the woman and her child are otherwise authorized to be. In the 105th Congress, Rep. Maloney was able to include in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) reauthorization bill a measure that allows state agencies to use the WIC food program funds to provide educational materials on breastfeeding, and allows state agencies to use additional WIC funds to purchase breast pumps.

The Breastfeeding Promotion Act – H.R. 2790 includes four provisions:
1. Protects breastfeeding under civil rights law: The bill clarifies the Pregnancy Discrimination Act of 1978 to protect breastfeeding under civil rights law. This will ensure that women cannot be fired or discriminated against in the workplace for expressing breast milk or breastfeeding during lunch or breaks.

2. Provides tax incentives for employers: With more than half of mothers with infants (less than one year of age) in the work force, it is important to promote a mother-friendly work environment. The bill encourages employers to set up a safe, private, and sanitary environment for women to express (or pump) breast milk by providing a tax credit for employers who set up a lactation location, purchase or rent lactation-related equipment, hire a lactation consultant or otherwise promote a lactation-friendly work environment. Many companies would be able to receive a tax credit of up to fifty percent of their related expenses.

3. Seeks minimum safety standards for breast pumps: The bill requires the Food and Drug Administration to develop minimum quality standards for breast pumps to ensure that products on the market are safe and effective based on efficiency, effectiveness, and sanitation factors (in addition to providing full and complete information concerning breast pump equipment).

4. Allows breastfeeding equipment to be tax deductible: The bill amends the tax laws to include breastfeeding equipment and services as deductible medical care expenses.

The status of this bill (or any House or Senate bill) can be tracked at: http://thomas.loc.gov where information is given regarding which committees the bill has been referred to and the status of the bill within each committee. H.R. 2790 has been referred to the House Ways and Means Committee, the House Energy and Commerce Committee (who referred it on to its Subcommittee on Health), and the House Education and the Workforce Committee (who referred it on to its Subcommittee on Labor-Management Relations).

To view the Congressional Research Service Reports:

CRS Report on the Benefits of Breastfeeding
http://www.house.gov/maloney/issues/breastfeeding/CRS_Report_on_Benefits_of_Breastfeeding.pdf
CRS Report on State Laws and Breastfeeding
http://www.house.gov/maloney/issues/breastfeeding/CRS_Report_on_State_Breastfeeding.pdf
Fact Sheet on H.R. 2790
http://www.house.gov/maloney/issues/breastfeeding/2790Summary.pdf

Actions for Breastfeeding Advocates:
There are a number of actions that can be taken at present to support and advance this bill through the legislative process.
1. More co-sponsors of the bill are needed. Write or contact your House representative to Congress and ask that he or she sign on as a co-sponsor to H.R. 2790
2. Contact each member of the committees to which this bill was referred, urging them to report out favorably on the bill and why it is so important to mothers and babies

Ways and Means Committee
http://waysandmeans.house.gov/members.asp
House Energy Committee’s Subcommittee on Health
http://www.house.gov/commerce/members.htm
Subcommittee on Employer-Employee Relations
http://edworkforce.house.gov/members/108th/mem-eer.htm

3. If you are a member of a breastfeeding task force, coalition, or professional association, request that your organization send a letter of support for this bill to members of the respective committees to demonstrate a wide base of support and need for such a bill. For further information you can contact Rep. Maloney’s office at: www.house.gov/maloney/ or her legislative assistant Edward Mills at (202) 225-7944 or edward.mills@mail.house.gov.

WIC Reauthorization Delayed

The Child Nutrition Act of 1966: P.L. 89-642 (October 11, 1966) was an anti-hunger initiative begun by the Johnson Administration as part of its "War on Poverty" and has been amended numerous times since then. It permanently authorizes the special milk program and the school breakfast program. The special supplemental nutrition program for women, infants, and children (WIC), which provides federal grant funds to states for monthly food packages and nutrition education for low-income mothers and young children, is authorized under this Act through FY2003, as is federal spending for state administrative expenses (SAE) associated with the operation of child nutrition meal service programs and the nutrition education and training (NET) program.
http://www.senate.gov/~agriculture/Legislation/Agricultural%20Law/FNS/cna66.pdf

These nutrition programs are a $12 billion yearly commitment by the federal government to the health and nutrition of children and families and are financed by annual agricultural appropriations laws. They are administered by the Food and Consumer Service of USDA. Changes to the authorizing statutes generally are made by the Agriculture Nutrition and Forestry Committee in the Senate. In the House, the Education and the Workforce Committee deals with most changes to child nutrition program authorizing statutes, although the Agriculture Committee usually is involved when proposed changes concern commodity distribution, food issues, and requirements affecting agricultural interests and the farmers market nutrition program.

Currently, a number of additional bills have been filed that would make changes to the Child Nutrition Act and have delayed the reauthorization process. One bill has asked to extend the authorization for the expiring provisions for another year while new legislation is prepared to improve provisions within the Act.

Actions for Advocates:
1. Continue to urge Members and their staff, especially those on the Senate Agriculture Committee: http://www.frac.org/html/federal_food_programs/cnreauthor/AGRICU-108.PDF
and on the House Education and the Workforce Committee:
http://www.frac.org/html/federal_food_programs/cnreauthor/edandworkforce.PDF
to use this period prior to a House and Senate mark up to do no harm to the child nutrition programs and enact positive improvements to the programs. It remains especially important to remind legislators of the importance of breastfeeding and breast milk to the health of infants as well as how provision of breast milk helps reduce the risk of overweight and obesity.
2. You may also wish to write to Eric Bost, the Under Secretary for Food, Nutrition, and Consumer Services at the USDA, urging him to continue his work for securing the $20 million in the President’s proposed budget for breastfeeding peer counseling within WIC. Please remind him that the peer counseling programs have been shown to be the most effective when peer counselors and mothers also have access to a lactation consultant.

Eric Bost, Under Secretary for Food, Nutrition and Consumer services
USDA, Room 240-E
1400 Independence Ave, S.W.
Washington, DC 20250
Fax 202 690-3100

3. Several sources of information were summarized from the Food Research and Action Center (FRAC) at http://www.frac.org.

FDA ALERTS PUBLIC REGARDING RECALL OF
POWDERED INFANT FORMULA

FOR IMMEDIATE RELEASE
P02-46
November 1, 2002

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration today is alerting the public to the voluntary recall of powdered infant formula announced by Wyeth Nutritionals Inc., Georgia, Vermont. Certain lots of powdered infant formula manufactured between July 12 and September 25, 2002, may be contaminated with Enterobacter sakazakii. E. sakazakii is a foodborne pathogen that can in rare cases cause sepsis (bacteria in the blood), meningitis (inflammation of the lining of the brain), or necrotizing enterocolitis (severe intestinal infection) in newborn infants, particularly premature infants or other infants with weakened immune systems. No illnesses have been reported to date in connection with this contamination.
The powdered infant formula was distributed nationwide in retail stores and amounts to approximately 1.5 million cans. The affected products can be identified by an expiration/use by date, embossed on the bottom of the can of: 07 28 05, 08 28 05 and 09 28 05. The products also can be identified by a six-digit character embossed on the bottom of the cans. The first four characters include: K12N through K19N; L07N through L30N; and N03N through N25N. The products include:
* Baby Basics by Albertson's Infant Formula with Iron 2 LB (908g)
* Baby Basics by Albertson's Infant Formula with Iron 1 LB (454g)
* Baby Basics by Albertson's Soy Infant Formula with Iron 2 LB (908g)
* Baby Basics by Albertson's Soy Infant Formula with Iron 1 LB (454g)
* Baby Basics by Albertson's Formula for older infants with iron 1 LB. 15.7 oz (900g)

* Kozy Kids Infant Formula with Iron 16 oz (454g)
* Kozy Kids Soy Infant Formula with Iron 16 oz (454g)

* CVS Soy Infant Formula with Iron 16 oz (454g)

* Hill Country Fare Infant Formula with Iron 32 oz (2 LB) 908g
* Hill Country Fare Infant Formula with Iron 16 oz (1 LB) 454g
* Hill Country Fare Soy Infant Formula with Iron 32 oz (2 LB) 908g
* Hill Country Fare Soy Infant Formula with Iron 16 oz (1 LB) 454g * HEB Baby Infant Formula with Iron 32 oz (2 LB) 908g * American Fare Little Ones Infant Formula with Iron 2 LB (908g)
* American Fare Little Ones Soy Infant Formula with Iron 2 LB (908g)
* American Fare Little Ones Formula for Older Infants with Iron & Calcium 1 LB 15.7 (900g)

* HomeBest Soy Infant Formula with Iron 2 LB. (908 g)

* Safeway Select Infant Formula with Iron 2 LB (908g)
* Safeway Select Infant Formula 2 1 LB 15.7 oz (900g)

* Healthy Baby Infant Formula with Iron 2 LB (908g)
* Healthy Baby Infant Formula with Iron 1 LB (454g)
* Healthy Baby Soy Infant Formula with Iron 2 LB (908g)
* Healthy Baby Formula for Older Infants with Iron 1 LB 15.7 oz. (900g)

* Walgreens Infant Formula with Iron 16 oz (454g)

* Parent's Choice Infant Formula with Iron 2 LB (908g)
* Parent's Choice Infant Formula with Iron 16 oz (454g)
* Parent's Choice Soy Infant Formula with Iron 2 LB (908g)
* Parent's Choice Soy Infant Formula with Iron 35oz (1 kg)
* Parent's Choice 2 Infant Formula with Iron 1 LB 15.7 oz (900g)

The contamination was first detected during a special E. sakazakii sampling FDA conducted at the Vermont facility. This special sampling and analysis is being conducted at all major, domestic manufacturers of powdered infant formula.
Consumers who have purchased the powdered infant formula are urged to return the product to the place of purchase for a full refund. Consumers with questions may contact Wyeth at 1-888-526-5376.

AAP Breastfeeding Book

The recent purchase by Ross Product Division of 300,000 copies of the American Academy of Pediatrics (AAP) new book, New Mother’s Guide to Breastfeeding, has presented another opportunity for a formula manufacturer to whitewash its image at the expense of new mothers and babies. Ross has placed its teddy bear logo and name on these books with the intent of distributing them in hospitals and through health care providers. The AAP Board of Directors and Executive Board welcomed this opportunity as a means of securing the label of “best seller” for the book to better position it in retail book stores. The book sells for $13.95. A 10% royalty on 300,000 books equals $417,000, just about what the AAP said it netted from the deal. Being able to state that the book was a “best seller” (because Ross had bought 300,000 of them) would make the book more attractive and give it more shelf space at the retail level. This would help cut out the competition. By essentially cheating, the AAP could secure a much better placement of its book.
It is interesting to note that as the AAP sold out to formula companies, the editor of the book, the contributors to the book, and the hard working Breastfeeding Section of the AAP were never made aware of this back-room deal until after it had taken place. While the AAP stated that they wished to get the book in the hands of more mothers they were looking for a means to more effectively cut out competing books from their market. Ross had actually approached a number of lactation consultants and members of the breastfeeding community for the purpose of purchasing their books on breastfeeding to put in the hospital discharge bags. When Ross found that LCs and breastfeeding supporters had no intention of selling out, lending their names to enhance that of Ross, or in any way wishing to be part of such underhanded dealings that violated the International Code of Marketing of Breast Milk Substitutes, Ross turned to their friends whom they could count on – the AAP. The AAP agreed with the reasoning promulgated by Ross that breastfeeding mothers are actually better customers than formula feeding moms. This is because as Ross states, “when breastfeeding mothers wean from the breast to infant formula when they discontinue nursing, they are likely to remain on infant formula longer before switching to whole milk.” Ross views breastfeeding mothers as a “futures market.” This reasoning is completely contrary to the AAP’s own statement on breastfeeding, thus illustrating that Ross’s real goal is premature weaning for the purpose of growth in formula sales.

Actions for Breastfeeding Advocates
1. Write to the AAP regarding your views on this situation.

Joe Sanders, MD, Executive Director
American Academy of Pediatrics
141 Northwest Point Blvd
Elk Grove Village, IL 60007-1098
www.aap.org

2. tell your own pediatrician what you think about this

3. do not accept this book if it is offered to you in the hospital, birthing center, doctor’s office, or clinic

4. do not purchase the book

5. if you receive the book as a gift from a health care institution, return it to the AAP

6. if you are a health care professional do not give the book to mothers or families

New Infant Formulas with DHA and ARA

The recent addition of the long chain polyunsaturated fatty acids DHA and ARA to infant formulas and baby foods may not be safe. The Institute of Medicine is currently undertaking studies on these ingredients for safety. While the FDA has allowed them onto the market, it has not actually approved them for use. The FDA simply raised no questions to Martek Biosciences (the manufacturer of the fatty acids) when it applied for its GRAS status (generally recognized as safe). Since most of the studies and clinical trials of these formulas were conducted on small numbers of subjects (babies), the FDA expects formula companies that use this fatty acid preparation will conduct what is called “postmarket surveillance” for adverse effects. This means that the companies essentially have the 4 million babies born each year in the US as their experimental subjects to feed them these formulas and see what happens. Parents do not know that the formulas have not been FDA approved, are unaware that there may be unknown side effects, and are completely oblivious to the fact that their babies are being experimented on without their informed consent.

Parents and most health care providers are also unaware that the DHA is extracted from fermented microalgae and the ARA comes from soil fungus. These ingredients are not part of the normal food chain and have demonstrated side effects in animal testing such as steatorrhea (fat loss in the stool). In fact, NABA has started to receive reports of babies experiencing watery, explosive diarrhea and vomiting from the use of these formulas.

Both Mead Johnson and Ross Products Division have engaged in extremely aggressive marketing of these products. There have been a number of reports to NABA describing Mead Johnson salesmen walking onto the maternity unit, removing all of the standard Enfamil formula and replacing it with Lipil (the fatty acid supplemented formula) without the knowledge or permission of ANYONE in the hospital. The salesmen then tell physicians and nursing staff that Mead Johnson does not make Enfamil anymore and that this is what should be used. This is not true and is then followed up with in-services to promote the use of the formula. There is almost no evidence that these formulas pose any advantage to babies over standard formulas and can be as much as 45% more expensive when parents buy them in the store. The advertising to parents has been so misleading that NABA has received reports of mothers asking their health care providers for the “formula with breast milk in it” or the “breast milk formula.”

Aggressive marketing pays off. Martek saw sales of its nutritional products increase 183% for the first 9 months of 2002 over the same period last year. 80% of the revenue was generated from sales of Martek’s oils to formula companies. Mead Johnson’s second quarter earnings in 2002 increased 18% over the same period in 2001, which was attributed to their introduction of Lipil.

Actions for Breastfeeding Advocates
1. report all incidents of diarrhea, vomiting, intolerance, etc in babies who have been given either Lipil or Ross Similac Advance to the FDA MedWatch program as well as to the respective formula manufacturer. www.fda.gov. It is extremely important to do this in order to establish a record of the problem and to help protect babies who cannot protect themselves from relentless assaults on their health

2. advise parents that these formulas pose no advantage to their infant and that they are being investigated for safety

3. report all marketing excesses to the Federal Trade Commission, www.ftc.gov. This includes any print materials given to parents that state either of these formulas is similar to breast milk or will make the baby as smart as a breastfed infant. This is false and misleading advertising since it causes the consumer to purchase the product thinking that their baby will be more intelligent

4. inform your hospital that these formulas are being investigated for safety and are experimental. Ask about the hospital’s liability if the formula is given to the baby without the knowledge or consent of the mother. Make sure the following departments are aware of the information in this alert:
Corporate Compliance
Ethics Committee
Risk Management
Pediatric Practice Committee
Legal Department

Fatal Infections from Powdered Infant Formula

The recent death from meningitis of a hospitalized US preterm infant due to consuming Portagen formula is the latest in a growing number of unfortunate incidents involving powdered infant formulas. Clusters of infections and deaths of neonates fed powdered infant formulas have been reported worldwide since 1961, including the recent death of a full term infant in Belgium and a full term baby in Iceland who suffered permanent neurological sequelae. Central to these outbreaks over the last 40 years is Enterobacter sakazakii, a gram-negative rod-shaped bacterium that causes sepsis, necrotizing enterocolitis (NEC), and meningitis in neonates. Fatality rates can be as high as 50%. Any babies who recover from the brain abscess and ventriculitis caused by the meningitis suffer mental and physical developmental delays. The death of the preterm US baby occurred in April of 2001, but the manufacturer of the product (Mead Johnson) did not recall it until April of 2002. More than 17,000 cans of this formula were in circulation for an entire year. Powdered infant formula products are commonly used in many hospitals, especially the NICU setting, with some hospitals using powdered formula as the principal source of patient feeding. E. sakazakii has also been traced back to the powdered formulas used to fortify human milk feedings. It is a common contaminant of powdered formula, present in as many as half of all powdered formulas tested. Even low levels of contamination that are within internationally accepted limits can lead to development of infection. It is extremely resistant to heat and of great concern is the increasing antibiotic resistance being observed among Enterobacter species.

It is important to realize that powdered infant formula is not sterile and provides an excellent medium for the growth of the bacteria present in the powder. The FDA has become increasingly aware that a substantial percentage of premature neonates in NICUs are being fed non-commercially sterile dry infant formula. Many of these babies are also fed a transition formula for low birth weight babies after discharge that is available in powdered form. Some of the specialty formulas are only available in powdered form. Portagen is used for babies with conditions of decreased ability to metabolize long chain fatty acids. Human milk can be skimmed and fed to these babies. The FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available. The Centers for Disease Control and Prevention (CDC), the FDA, and the American Dietetic Association (ADA) have all published guidelines for appropriate formula use, including details on proper preparation, storage, and administration. They stress minimizing “hang time” (the amount of time formula is held at room temperature in the feeding container and accompanying lines during enteral tube feeding) to no more than four hours. “Longer times should be avoided because of the potential for significant microbial growth in reconstituted infant formula.”

What is notably absent from any of the guidelines or recommendations is the basic preventive action of breastfeeding or the use of banked human milk. Paying for banked human milk is less expensive than the price tag for disease and the loss of brain function or life.

Actions for Breastfeeding Advocates
1. contact the CDC, FDA, and ADA and request that breastfeeding and the use of banked human milk be added to the guidelines as the number one mechanism for prevention of sepsis, NEC, and meningitis from which vulnerable infants are needlessly suffering and dying

2. inform your special care nursery about the dangers of using powdered infant formula

3. become knowledgeable regarding how to obtain banked human milk, how to engineer skimmed human milk, and how to modify human milk for special situations

References
American Dietetic Association. Preparation of formula for infants: guidelines for healthcare facilities. Chicago, IL: 1991

Baker RD. Infant formula safety. Pediatrics 2002; 110:833-835

Biering G, Karlsson S, Clark NC, et al. Three cases of neonatal meningitis caused by Enterbacter sakazakii in powdered milk. J Clin Microbiol 1989; 27:2054-2056

Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula – Tennessee, 2001. MMWR 2002;51:297-300

FDA. Recalls and Safety Alerts. Powder product recall. Available at: www.fda.gov/oc/po/firmrecalls/meadjohnsono3_02.html

FDA. Letter to health care professionals. Available at: www.cfsan.fda.gov
Lai KK. Enterobacter sakazakii infection among neonates, infants, children, and adults: case reports and a review of the literature. Medicine 2001; 80:113-122
Muytjens HL, Roelofs-Willemse H, Jaspar G. Quality of powdered substitutes for breast milk with regard to members of the family Enterbacteriaceae. J Clin Microbiol 1988; 26:743-746

Nazarowec-White M, Farber JM. Thermal resistance of Enterobacter sakazakii in reconstituted dried-infant formula. Lett Appl Microbiol 1997; 24:9-13
Simmons BP, Gelfand MS, Haas M, et al. Enterbacter sakazakii infections in neonates associated with intrinsic contamination of a powdered infant formula. Infect Control Hosp Epidemiol 1989; 10:398-401

Van Acker J,DeSmet F, Muyldermans G, et al. Outbreak of necrotizing entercolitis associated with Enterobacter sakazakii in powdered milk formula. J Clin Microbiol 2001; 39:293-297

Weir E. Powdered infant formula and fatal infection with Enterobacter sakazakii. JAMC 2002; 166:1570

Asthma and Breastfeeding

23 September 2002
from Baby Friendly of UK
www.babyfriendly.org.uk

Lancet asthma study refuted. The study by Sears and colleagues in the Lancet (20 September 2002) finds no protective effect of breastfeeding against asthma and other allergic diseases. This contradicts the findings of other studies, notably research published in July by Oddy and colleagues. The difference in the findings is likely to be approaches in relation to exclusive breastfeeding. Sears compares babies who were breastfed for more than 4 weeks with those who were not. Just 15% of babies are classed as 'exclusively' breastfed, and the author accepts that many of these "received a nightly
formula feed while in hospital." This differs from the internationally accepted definition of exclusive breastfeeding, which is that babies receive no food or drink other than breastmilk. Furthermore, using a cut-off point of 4 weeks of 'exclusive breastfeeding' means that the breastfeeding group would in fact have included babies whose mothers stopped breastfeeding or moved to mixed bottle-and breastfeeding shortly after 4 weeks.

Oddy, on the other hand, found that children who had been exclusively breastfed for their first 4 months were less likely to suffer from asthma at age 6 years. It is believed that a single feed of artificial infant formula to a susceptible baby can trigger an allergic response. The findings of Sears and colleagues should therefore be treated with great caution.

Oddy WH et al (2002). Maternal asthma, infant feeding, and the risk of asthma in childhood. J Allergy Clin Immunol 110: 65-7

Sears MR et al (2002). Long-term relation between breastfeeding and development of atopy and asthma in children and young adults: a longitudinal study. Lancet 360: 901-07.

West Nile Virus and Breastfeeding

This notice is available from the Centers for Disease Control and Prevention at:
http://www.cdc.gov/ncidod/dvbid/westnile/qa/breastfeeding.htm

Q. Can West Nile virus be transmitted through breast milk?
A. Based on a recent case in Michigan, it appears that West Nile virus can be transmitted through breast milk. A new mother in Michigan contracted West Nile virus from a blood transfusion shortly after giving birth. Laboratory analysis showed evidence of West Nile virus in her breast milk. She breastfed her infant, and three weeks later, her baby's blood tested positive for West Nile virus. Because of the infant's minimal outdoor exposure, it is unlikely that infection was acquired from a mosquito. The infant was most likely infected through breast milk. The child is healthy, and does not have symptoms of West Nile virus.

Q. Should I continue breastfeeding if I am symptomatic for
West Nile virus?
A. Because the health benefits of breastfeeding are well established, and the risk for West Nile virus transmission through breastfeeding is unknown, the new findings do not suggest a change in breastfeeding recommendations. The American Academy of Pediatricians and the American Academy of Family Physicians recommend that infants be breastfed for a full year of life. Lactating women who are ill or who are having difficulty breastfeeding for any reason, as always, should consult their physicians.

Q. Should I continue breastfeeding if I am not symptomatic
for West Nile virus?
A. Yes. Because the health benefits of breastfeeding are well established, and the risk for West Nile virus transmission through breastfeeding is unknown, the new findings do not suggest a change in breastfeeding recommendations.

Q. If I am breastfeeding, should I be tested for West Nile virus?
A. No. There is no need to be tested just because you are breastfeeding.

Q. Is there any evidence that West Nile virus is transmitted from mother to child during pregnancy or during birth?
A. There is no evidence that West Nile virus can be transmitted during pregnancy or birth.

Q. Are infants at higher risk than other groups for illness with West Nile virus?
A. No. West Nile virus illnesses in children younger than 1-year-old are infrequent. During 1999-2001, no cases in children younger than one year of age were reported to CDC. Of the over 2500 total West Nile Virus cases in 2002, only four were less than one year of age. We know that one of these infants was not breastfeeding, and investigation of the other infants is underway.

Q. If I am breastfeeding, should I use insect repellent containing DEET?
A. Yes. Insect repellents help people reduce their exposure to mosquito bites that may carry potentially serious viruses such as West Nile virus, and allow them to continue to play and work outdoors. There are no reported adverse events following use of repellents containing DEET in pregnant or breastfeeding women.

Marketing Practices of Pharmaceutical Companies—Drug
Industry has been Told to Stop Gifts to Doctors

The Office of the Inspector General of HHS published a Special Advisory Bulletin in the August 30, 2002, Federal Register regarding offering gifts and other inducements to Medicare and Medicaid beneficiaries to influence their choice of a Medicare or Medicaid provider, practitioner, or supplier. A copy can be downloaded from the Federal Register site. www.archives.gov/federal_register/index.html

On October 3, 2002 the Federal Register contained another notice from the OIG of HHS regarding the draft compliance program for pharmaceutical manufacturers. A full copy can be obtained from the Federal Register or from the OIG web site at http://oig.hhs.gov. This is very important since it spells out what violates the federal anti-kickback statute and the formula companies qualify. NABA has e-mailed the OIG asking them about the payoffs formula companies give to hospitals and has been informed that these practices violate the anti-kickback statute. Now we have a chance to comment on this draft. Comments are due by December 2.

Actions for Breastfeeding Advocates
Send all comments to:
Office of the Inspector General
Department of Health and Human Services
Attention: OIG-8-CPG, Room 5246, Cohen Building
330 Independence Ave, SW
Washington, DC 20201

Inform your corporate compliance department that if your hospital, agency, or medical office accepts formula company gifts, money, or other inducements to recommend its products, they may be in violation of the federal anti-kickback statute.