Marketing fats to fatten profits
MeadJohnson, a U.S.-based infant formula maker, is claiming that the addition of a lipid blend to their formulas marketed in the U.S. improves the levels of essential fatty acids DHA (docosahexaenoic acid) and ARA (arachidonic acid) in their formulas. It claims that the fattyacids-enhanced infant formulas improve the development of babies’ eyes and brains. There is no doubt about the critical functions of these essential fatty acids in infant and young child nutrition, but thus far research results remain non-conclusive about their efficacy when added to infant formulas. Moreover, questions of safety of adding fats derived from microalgal and soil fungi remain.
Yet the promotions state, “mothers can feel confident that no formula is closer to breastmilk.” In its deliberations to address the addition of lipid blends to infant formulas, the U.S. Food and Drug Administration raised a number of concerns casting doubt not only on the adequacy of information to determine safety and efficacy of the additions but also regarding adequacy of the clinical trials required for premarket approval.
Despite these concerns, the FDA “allowed” Martek Biosciences (producer of the DHA and ARA lipids) to market the oils for inclusion in infant formulas, but did not grant “approval.” FDA considered the clinical trials to be insufficient and is expecting the infant formula manufacturers to report adverse affects as part of a “post-market surveillance” monitoring.
The FDA informed Martek that, “a food ingredient is safe is a time dependent judgement that is based on general scientific knowledge as well as specific data and information …for these reasons, the FDA would expect any infant formula manufacturer to monitor through scientific studies and rigorous post-market surveillance infants who consume such a formula.” It seems that all babies born in the U.S. consuming the new formula will now be part of an ongoing experiment to assess its efficacy and safety.
FDA Food Safety and Applied Nutrition comments:
Ø Martek assumes that because ARA and DHA are present in human milk that the digestion and absorption of DHA and ARA from their lipids will be the same as that from human milk.
Ø Even though Martek acknowledges some adverse effects in the highest doses tested in rats, such as significant liver enlargement, and spleen enlargement, possible effects on the kidney and a change in blood chemistries, Martek concludes that these are not adverse toxicological findings related to its fatty acids.
Ø Martek notes that 14 published clinical trials involving 1,500 term and preterm infants, with about 700 consuming the Martek enhanced formulas demonstrate no adverse effect on growth and notes that internationally there are no reports of adverse effects. Although there have been reports of increased SIDS in those who consumed formula supplemented with fish oils, Martek claims that none of the SIDS deaths were related to dietary treatment.
Ø FDA noted that studies have reported unexpected deaths among infants consuming these supplemented formulas. The deaths were attributed to SIDS, sepsis and necrotizing enterocolitis. Other studies have reported adverse effects such as diarrhea, flatulence, jaundice and apnea.
Ø Also the FDA noted that Marek had not taken into account that the bioactive DHA and ARA in human milk are part of a complex matrix, including various forms of fatty acids and that the physiological relationships are not accounted for by the simple addition of the Martek lipid mixture to infant formula.
FDA Food Advisory Committee on Infant Formula
This committee raised questions concerning the appropriateness and completeness of clinical trails for infant formulas and recommends considerable overhaul of definitions and study design.
They questioned the inappropriateness of generalizing the results from one population to another population, for example studies done with preterm infants and applying the results to term infants or studies done with healthy term infants, or transferring results from one product to another. Should studies be interpreted in comparison to healthy infants exclusively breastfed and not just on whether the composition is similar to human milk?
How does a study conclude that a product supports normal physical growth? Are they compared to other formula-fed infants or are they compared to exclusively breastfed infants? Additionally these studies only follow growth for the first 12 months. Longterm results must be included to take into account for example increased obesity at a later age for formula-fed infants. Also incremental growth standards are needed to adequately assess if a product supports normal growth.
The current regulations address safety and nutrition similarity but not efficacy. Efficacy should take into account all health criteria and not just the safety of an ingredient.
The Advisory committee also noted that independent analysis is needed to study the very high attrition rates - an attrition rate of 25% was common – in these trials. When is a study rendered invalid related to rates of attrition? What are the reasons for attrition – formula intolerance, adverse effects?
The U.S.-based National Alliance for Breastfeeding Advocacy (NABA)
Our sister organization, NABA, reports that mothers should be informed that this formula is under surveillance by the Institute of Medicine, and NABA concludes that U.S. infants are unwitting participants in an uncontrolled experiment of the safety and side effects of its use. NABA continues to receive reports of the fortified formula as causing watery stools, explosive diarrhoea and vomiting in babies.
The Labelling Committee of the Codex Alimentarius
It has recommended a prohibition on health and nutrition claims for foods for infants and young children (See INFACT Canada Newsletter Spring 2002). It is vital that this prohibition be enforced so that the formula makers cannot mislead parents. It is also vital that we protect this clause by giving it as much publicity as possible and to lobby our governments to support its enforcement.
Is Canada the next target?
As we go to print we have received information that Canada has given the nod to MeadJohnson’s re-engineered formulas. ACTION: Please write Health Minister Anne McLellan to let her know that we do not want Canadian infants engaged in a post-market surveillance feeding trial! Moreover, urge the minister to enforce Canada’s Food and Drug regulations prohibiting health and nutrition claims for these products.
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