Note: These comments are from posts to a list serv for lactation providers and supporters, and are not from a peer reviewed journal.
| Date: | Tue, 7 Jan 2003 |
| Subject: | Lipil |
Denny has talked to us about the pediatrician that stated the fatty acid additives in Lipil are exactly the same as what is in breast milk. This sounds like he or she has just attended an inservice by a formula salesman and is parroting back the buzz words used to dupe health care providers into recommending the formula! Actually these fatty acids are nothing like what is in breast milk and pose a number of known and unknown risks to the infants who consume them. The DHA is extracted from fermented microalgae and the ARA is extracted from soil fungus. The breast does not use either of these items to manufacture its fatty acids, and these sources are new to the food chain. Each of the processed oils has its own fatty acid composition, adding a number of fatty acids to formula that already are contained in the plant oils mixed into the base formula. Human fatty acids are structurally different from manufactured ones from plant sources. Human fatty acids interact with each other in a special matrix. Just because they perform as they do in human milk does not mean they will perform at all in an artificial construct. One study has started to question if the large fat supplementation of formula is contributing to the obesity epidemic (Massiera F. Arachidonic acid and prostacyclin signaling promote adipose tissue development: a human health concern. J Lipid Research 2002; published on line ahead of print November 4, 2002).
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Side effects have been reported in animal studies of the DHA and ARA, such as; oily soft stool (steatorrhea) and oily hair coat in rat studies. In four week exposures, rat pups had higher liver weights, in three month exposures they showed elevated serum alkaline phosphatase levels, and undeveloped renal papilla. Fungal food sources have the potential of acting as opportunistic pathogens in immunocompromised individuals. An extensive review of this topic was done published in the Journal of Nutrition, November 1998 Supplement; Vol 128, Number 11S. It concluded that there was not enough evidence to support the addition of these fatty acids to formula.
Varying or randomly adding fatty acids to formula does not always translate into optimal delivery of these fatty acids to the infant. These fatty acids were not approved by the FDA for use. They were simply allowed onto the market with the stipulation of post market surveillance. This means give the formula to as many babies as possible and see what happens. Since the clinical trials (experiments on babies) were done on small numbers, this allows the formula companies to have access to the entire population of babies born in the US every year, 4 million. The formulas are under study by the Institute of Medicine for safety. This represents an enormous uncontrolled experiment that bypasses informed consent and is staunchly defended by health care professionals who are wedded to the infant formula industry.
NABA has received many, many reports of babies being fed Lipil and experiencing watery, explosive diarrhea. This needs to be reported to the manufacturer and the FDA as a side effect or adverse event of this formula. This is so similar to the selling of olestra (the stuff in potato chips that prevents a person from absorbing the fat which caused painful cramping and diarrhea in many adults) that it is a scary comparison. We do not know if babies lose fat, fat soluble vitamins or any other nutrients through the stool when they consume this formula. As a matter of fact, we know very little about this formula.
Formula salesmen have walked onto hospital maternity units and removed all of the standard formula, lying that it is no longer being produced. This formula is more expensive than regular formula so the companies have profited greatly by making sure that the lower priced formula is not made available. How many more babies have to be made sick in order for the health care system and government regulatory agencies to pay attention to something put on the market to make money. The only thing these additives do is help a company capture a larger share of the formula market.
The latest issue of INFACT Canada’s newsletter carries a great tidbit of information from a few years ago when Martek Biosciences was recommended as a strong stock investment: ” Infant formula is currently a commodity market, with all products being almost identical and marketers competing intensely to differentiate their product. Even if Formulaid (the name of the DHA/ARA fatty acid combination) has no benefit, we think it would be widely incorporated into formulas as a marketing tool and to allow companies to promote their formula as closest to human milk.” No mention is made at all about health consequences because it is of no importance. Promoting formula in this manner is false and misleading advertising and is against the law.
Health care providers who buy into the hype about this formula or Similac Advance have not done their homework. Maybe we need a conference on this topic to help people understand formulas and how to remove the marketing barrier to breastfeeding that they present.
Marsha Walker, RN, IBCLC
Weston, MA
| Date: | Wed, 8 Jan 2003 |
| Subject: | Lipil |
Halle and a number of other Lactnetters have asked my permission to use yesterday’s post about Lipil and the addition of the long chain polyunsaturated fatty acids (LCPUFA) to formula. You may certainly use the post to help parents and health care professionals understand the nature of what we are dealing with and how they are being used by formula companies to make a profit. I keep finding more and more frightening things about tinkering with formula. For example, animal studies have begun to show that when these fatty acids are added to the diet and incorporated into plasma and tissue lipids it increases the susceptibility of membranes to lipid peroxidation and disrupts the antioxidant system. Breast milk is full of antioxidants that protect cells from the damaging effects of oxygen radicals (highly reactive chemicals). These oxygen radicals play a part in provoking diseases such as atherosclerosis, some forms of cancer, and a host of other diseases and conditions. (Song JH, et al. Polyunsaturated (n-3) fatty acids susceptible to peroxidation are increased in plasma and tissue lipids of rats fed docosahexaenoic acid-containing oils. J Nutrition 2000; 130:3028-3033).
How can we know if formulas such as Lipil, Similac Advance, all the store brand formulas from Wyeth, the soy formulas, etc will or will not increase the susceptibility of infants fed these concoctions to the host of diseases and conditions that are already at epidemic levels. Will this diet simply exacerbate an already sad state of affairs, putting formula-fed babies at an even higher risk for poor health outcomes? The clinical trials of the supplemented formulas did not last longer than 12-18 months. We know nothing of what happens to people in the long term who consume only these formulas during infancy.
Marsha Walker, RN, IBCLC
Weston, MA
Additional resources compiled by kellymom.com:
What should I know about infant formula? @ 
Do nursing mothers need DHA supplements? @
Replacing Mother– Imitating Human Breast Milk in the Laboratory details research questioning the alleged benefits of adding “novel” omega-3 and omega-6 fatty acids, produced in laboratories and extracted from algae and fungus, into infant formulas.
Simmer K. Longchain polyunsaturated fatty acid supplementation in infants born at term (Cochrane Review). Cochrane Database Syst Rev. 2004;(2):CD000376.
Simmer K, Patole S. Longchain polyunsaturated fatty acid supplementation in preterm infants (Cochrane Review). Cochrane Database Syst Rev. 2004;(1):CD000375.
ARA and DHA: Breastmilk in a can by Jennifer Rebecca Thomas, MD, FAAP, IBCLC
DHA and ARA: Does your child need these supplements? by Vincent Iannelli, MD
New infant formula additives approved by FDA from the AAP Committee on Nutrition (AAP News Vol. 20 No. 5 May 2002, p. 209). Note: This wording is misleading, as infant formulas are never approved by the FDA. The FDA did not question the basis for the manufacturer’s GRAS notification (see below). Per the FDA, “The law does not require that FDA approve infant formulas but instead requires companies to provide certain information to FDA before they market new infant formulas. Manufacturers must provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. If such assurances are not provided, FDA will object to the manufacturer’s marketing of the formula; however, the manufacturer may market the new infant formula over FDA’s objection.”
Long-Chain Polyunsaturated Fatty Acid Supplementation Of Infant Formula by Kathleen Meister, M.S. (revised by Revised by Ruth Kava, Ph.D., R.D., Director of Nutrition, ACSH)
Auestad N, et al. Visual, cognitive, and language assessments at 39 months: a follow-up study of children fed formulas containing long-chain polyunsaturated fatty acids to 1 year of age. Pediatrics. 2003 Sep; 112(3 Pt 1): e177-83. “The present follow-up evaluation of growth, visual development, and neurodevelopmental outcomes at 39 months found no adverse effects or benefits of infant formula supplemented with DHA or with both DHA and ARA.”
Fewtrell MS, Morley R, Abbott RA, Singhal A, Isaacs EB, Stephenson T, MacFadyen U, Lucas A. Double-blind, randomized trial of long-chain polyunsaturated fatty acid supplementation in formula fed to preterm infants. Pediatrics. 2002 Jul; 110(1 Pt 1): 73-82.
Responses from the U.S. Food & Drug Administration to GRAS (Generally Recognized as Safe) Notifications
What is the GRAS Notification Program?
Agency Response Letter to Mead Johnson Nutritionals GRAS Notice No. GRN 000080 (December 11, 2001) “The agency has not, however, made its own determination regarding the GRAS status of the subject use of ARASCO [arachidonic acid-rich single-cell oil]. As always, it is the continuing responsibility of Mead Johnson to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.”
Agency Response Letter to Martek Biosciences Corporation GRAS Notice No. GRN 000041
Agency Response Letter to Wyeth Nutritionals International GRAS Notice No. GRN 000007 (Resubmitted as GRN No. 41)