Archive site - new site at www.babymilkaction.org

At the centre of the European debate about DHA Claims are two US companies -  Mead Johnson  and Martek Biosciences Corporation - who have been in hot water for their eagerness to promote their products.  In the US and Canada  there have been Private legal actions and investigations by the  US Food and Drug Administration, the Federal Trade Commission and Health Canada over their claims, described variously as 'repeated flagrant violation of the US industry self-regulation adjudications'  and as "unsubstantiated, unacceptable, misleading and unauthorized.”  

This marketing has been particularly aggressive in the black community in the US. According to one magazine: "In a recent interview, a lactation consultant told me of a mom was asking for "the formula with breast milk in it."

http://info.babymilkaction.org/sites/info.babymilkaction.org/files/FDA Womens eNews.pdf

Baby Milk Action is asking European citizens to contact their representatives in the European Parliament to vote for a Resolution supporting accurate information on formula and blocking the DHA claim. Professional bodies from anywhere in the world are also being asked to send messages of support. Click here for further information and to send a message.

 The FDA also has serious safety concerns and in response to a Freedom of Information request from Charlotte Vallaeys of the Cornucopia Institute in 2007  revealed that it had  recorded 98 reports of  adverse reactions to DHA fortified formulas. In a letter to Martek, the FDA said: "some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice and apnea in infants fed long-chain polyunsaturated fatty acids."  

The FDA is clear that its authorisation for the use of DHA in formulas is not an assurance of safety and was given on condition that the industry  conducted regular  post-market surveillance of  the safety of DHA/ARA. In response to a further request from the Cornucopia Institute in 2009 the US  Food and Drug Administration stated that it had received no reports of post-market surveillance and scientific studies evaluating the safety of DHA. 

http://info.babymilkaction.org/sites/info.babymilkaction.org/files/FDA Post market.pdfhttp://info.babymilkaction.org/sites/info.babymilkaction.org/files/DHA UPDATE 2010_0.pdf

Q& A pages on the US FDA website

What is the evidence that addition of DHA and ARA to infant formulas is beneficial?

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.

I understand that oils containing DHA and ARA have been added to infant formulas for several years in other countries. Isn't there information from those countries on any long-term benefits or adverse consequences of formulas containing these fatty acids?

Systematic monitoring efforts are not in place to collect and analyze information on effects of infant formulas containing DHA and ARA in countries where these formulas are in use.

Why has FDA asked manufacturers to do postmarket surveillance of infants consuming these formulas?

These are new ingredients that were not used in infant formulas in this country before early 2002, and infant formulas containing ARASCO (ARA Single Cell Oil) and DHASCO (DHA Single Cell Oil) have been marketed in other countries for only a few years. FDA views any evaluation of the safety of use of new food ingredients such as DHASCO and ARASCO as a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient. Therefore, scientific data that become available after specific products containing a new ingredient enter the market must be considered as a part of the totality of information about the ingredient. Pre-market clinical studies evaluating the effects of infant formulas containing DHASCO and ARASCO on physical growth and some aspects of development are short-term studies, while some studies suggest that feeding of infant formulas with oils containing DHA and ARA to infants may have long-term effects on growth and development. For all these reasons, manufacturers have been asked to closely monitor these new infant formulas in the marketplace.

Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002

www.fda.gov/Food/FoodSafety/Product-SpecificInformation/InfantFormula/ConsumerInformationAboutInfantFormula/ucm108079.htm 

 www.fda.gov/Food/FoodSafety/Product-SpecificInformation/InfantFormula/ConsumerInformationAboutInfantFormula/ucm108560.htm

The US Federal Trade Commission (FTC) also investigated the use of DHA  claims and advertisements. The FTC is a law enforcement agency, rather than a regulatory agency. It investigates specific advertising campaigns and reaches conclusions regarding particular claims for particular products. It does not make regulatory determinations about ingredients or products in general. That is the province of the US Food and Drug Administration.  The FTC wrote to Mead Johnson informing them of the resolution of an FTC inquiry into the DHA adverts after the company agreed to discontinue the challenged advertising.  The matter had been referred to the FTC  by the National Advertising Division of the Better Business Bureaus, the self-regulatory body. 

The FTC has also warned companies that it requires advertising claims related to health to be supported by “competent and reliable scientific evidence” (CRSE).  What constitutes CRSE in any given case will depend on the type of product and type of claim, and what experts in the field would require.  In some circumstances, it might require valid, controlled clinical studies, but in general, the FTC considers the entire body of reliable and relevant evidence, when assessing whether a claim is substantiated

http://info.babymilkaction.org/sites/info.babymilkaction.org/files/FTCtoMJ.pdf

FTC news release regarding warning letters  sent to marketers of children's vitamins based on the claims they were making for the Omega-3/DHA content of the vitamins. (2010)  www.ftc.gov/opa/2010/02/omega.shtm

Following all these investigations Mead Johnson has now toned down its vision and brain claims in the US - rarely using them. It makes no sense for the EU to approve the claims.  The  FDA is now proposing an investigation of 10,000 women to see how formula claims influence parents perceptions.

Laurie True, Executive Director of California Women, Infants and Children Program (CALWIC) has written to Glenis Willmott, MEP  to explain WIC's concerns about DHA health claims. http://info.babymilkaction.org/sites/info.babymilkaction.org/files/CALWIC to GW.doc

"The US Women, Infants and Children (WIC) Program has been negatively impacted by the use of unproven claims regarding DHA and other so-called “functional ingredients” that food manufacturers use to market infant formula and other foods (baby cereal, baby food, juice, etc.) which WIC provides to over 9 million low-income women and children under five. Not only do these foods cost more, thus wasting taxpayer money, but the accompanying marketing claims confuse and mislead WIC mothers and thus undermine their decision to initiate and persist with exclusive breastfeeding, recommended as the superior feeding choice by all world and national health advisory agencies."

WIC Food Package Should Be Based on Science:  Foods with New Functional Ingredients Should Be Provided Only If They Deliver Health or Nutritional Benefits

http://www.cbpp.org/cms/index.cfm?fa=view&id=3201  

"A recent study by USDA’s Economic Research Service (ERS) found that state WIC programs are spending $127 million more each year in federal funds for infant formula under their current contracts with infant formula companies — for formula products with DHA and ARA — than states would have paid under their previous contracts, after adjusting for inflation."

The US Food and Drug Administration  is calling for comments on their forthcoming research on health claims on infant formulas such as “supports brain and eye development.’’ The FDA wants to: assess women’s understanding of and response to various statements on infant formula labels. The study results will be used to help the Agency to understand the role that certain types of statements on infant formula labels have in influencing formula choice….The study will focus on purchase choice, perceived similarity of the formula to breast milk, and perceived likelihood that the formula has certain health benefits.  Deadline for comments 2nd May 

Experimental Study—(OMB Control Number 0910–NEW - http://www.regulations.gov    Refer to Docket No. FDA–2011–N–0098

http://info.babymilkaction.org/sites/info.babymilkaction.org/files/FDA Survey.pdf

see also Prof Marion Nestle's  Food Politics blog http://www.foodpolitics.com/  cites  US bans synthetic DHA ARA in organic formulas

 www.washingtonpost.com/wpdyn/content/article/2010/04/27/AR2010042704500.html