Sunday, June 22, 2014

The FDA's 2014 Final Rules and Guidance to the Infant Formula Act

               "The lack of appreciation for the breast reflects a lack of 
                appreciation of the female as a person.  When the fluid 
                responsible for sustaining human life is seen as essentially
                identical to a canned powder produced in a factory, it is easy
                to see how the appreciation of the breast (and with it, the
                female body) has been lost."  Milk, Money, and Madness:
                The Culture and Politics of Breastfeeding by Naomi Baumslag,
                M.D., M.P.H. and Dia L. Michels

In 1978-1979 an infant formula company eliminated chloride from some of the formulas they manufactured.  Infants fed those formulas were later diagnosed with metabolic alkalosis.  During the 1970's, there was concern about salt intake and its relationship with the development of high blood pressure.  Thus some manufacturers of infant formula decided to lower and even eliminate salt in their baby formulas.  Over 100 US infants were known to have acquired this deficiency disease caused by manipulations of their baby formula.  Metabolic alkalosis causes diarrhea, vomiting, dehydration, failure-to-thrive, kidney problems, and developmental delays.  One wonders how many infants died before the situation was recognized by the medical community.  Because of this incident, the Infant Formula Act of 1980 was passed to prevent such tragic outcomes because of the lack of regulation of the infant formula industry.   

Over the years the FDA has worked on revising this law. This is the 2014 rules and guidelines to manufacturers of infant formula.

There has been other tragic incidents in the years prior to and after the Infant Formula Act of 1980 and as recently as 2011.  Unlike the manufacturing of a adulterated infant formula, it has involved contamination of powdered infant formula by various organisms:  Salmonella, Enterobacter sakazakii (now called Cronobacter sakazakii).  Powdered infant formula is not a sterile substance and it has been known since 1958 to be sporadically contaminated with these organisms causing brain damage and death.  In the US in 2011, there was 13 cases of infants who were infected by E. sakazakii (1 death was recorded and other infants suffered the damaging effects of the infection).  In the past year there have been two court cases: one lawsuit against Mead Johnson (death of an infant) and also a lawsuit against Abbott (brain damage of an infant).  Neither family won their lawsuits.  

The CDC has issued guidelines for safer preparation of powdered infant formula with recommendations that newborns or young infants be given liquid infant formulas rather than the powdered.  If powdered, the recommendation is to boil the water used to make the formula to 158 degrees F./70 degrees C.  Then cooling to serve safely to infant. Similar to the World Health Organization's guidelines.  The FDA's recommendation is to boil the water for 1 minute and cool. 

These suspected contamination situations may have pushed the FDA to finalize their revisions of the Infant Formula Act.  Although it has been a process of 8 years.  One might suspect that the infant formula industry may have put considerable pressure on the FDA to delay the finalization of these rules.  Of particular interest to me was a recent letter written by the Chairman of the Committee on Energy and Commerce, Fred Upton (House of Representatives, Republican legislator from Michigan) in May of this year to Margaret Hamburg, Commissioner of the FDA asking that the "FDA postpone the implementation date until the agency engages in a meaningful dialogue with Congress and industry about the need for--and the science and data behind--the changes proposed, and the feasibility of their implementation." 

Congressman Fred Upton, according to the Center for Responsible Politics website receives campaign funds for the year 2013-2014 from the Pharmaceutical/Health Industries, Health Professionals, Electric, Oil & Gas, lawyers and law firms.  The company Abbott (Ross, a division of this company and well-know infant formula maker) mentions in their Campaign Finance website that Fred Upton was one of their top recipients of contributions through their PAC ($52,150).  Barack Obama was at the top of the recipients ($149,353). 

The FDA receives some of its funding through the Reagan-Udall Foundation not just from US taxpayers.  The Regan-Udall Foundation is "an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research." 

Some of the donations to this foundation from 2009 until now are from organizations like the National Business Group on Health*, Susan G. Komen for the Cure, Booz & Company (less than $30,00 per donor organization).  Some donations from PhRMA Foundation ($150,000-general donation, $400,000 medical evidence and surveillance program) and Bill & Melinda Gates Foundation $1,000,000 for project on TB drug regimens.  Donations from PhRMA are donations from the pharmaceutical industry which often includes the infant formula industry, for example Abbott Labs/Ross or Bristol Myers Squibb/Mead Johnson.

Will this new FDA ruling and guidance documents on infant formula safeguard our infants?  It remains to be seen.  Foremost, is the fact that "the FDA does not approve infant formulas before they can be marketed."  Thus their surveillance system, while better than nothing, is an after-the-fact system in which our infants are the guinea pigs.  While it is wonderful that these documents are available for all to read, they are difficult for the average person to understand their implications.  It is ominous that some Congressional leaders believe more in safeguarding the profits of industry over safeguarding the lives and health of our infants.  The saddest statement from my perspective is the FDA's comment , "...most infants in the US rely on infant formula for some portion of their nutrition.  An estimated 1 million infants in the US are fed formula from birth and by the time they are 3 months old, about 2.7 million rely on formula for at least part of their nutrition."

We live in a society that supports infant formula feeding despite the risks.   We believe that there are no risks to infant formula feeding in the USA.  But that belief is predicated on the rapid availability of medical help, antibiotics, and safe water.  It is also predicated on the ability of families to pay for it or the tax payers to subsidize it (through the WIC Program).  None of this appears to be cognizant of the growing instability of our financial systems particular in regard to the growing dissolution of the middle classes and growing numbers of families put into poverty.  Nor is there awareness of our growing destruction of our environment-contamination of water through oil spills and fracking, pesticides and herbicides, radioactivity spreading globally (Fukishima).  What about our growing antibiotic resistance?  Will a nation with greater numbers of chronically unemployed be able to subsidize the costs of medical care for infants fed suboptimally?  Not being breastfeed, is a huge financial burden on parents, on a nation.  We have been blinded to the health risks of infant formula.  Reading these documents, should be a wake up call for our country about the risks of infant formula and how politicians and industry have delayed some remedies to make a safer infant formula.
Copyright 2014 Valerie W. McClain  
*The National Business Group on Health is "the national voice of large employers dedicated to finding innovative and forward thinking solutions to the nations most important health care issues." (mission statement)  There are many large corporations in this Group.  Some of the members are: Nestle, Kellogg Company, Pepsi, Tyson Foods, CVS Caremark, Wal-mart stores, Target, AT&T, Verizon, Delta, JetBlue, BP, Shell Oil, Marriott, Walt Disney Company, Coca-Cola, CongAgra Foods, Hershey, Heinz, Chrysler, Abbott Labs, Bristol-Myers Squibb, Pfizer, Genentech, Home Depot, Gap, Publix, etc.  Note that companies like CVS, Wal-mart, Target, Publix sell their own store-brand infant formulas manufactured by Perrigo Nutritionals.

According to their website under public policy, "The National Business Group on Health's public policy activities provide members with the latest information and analysis of federal legislation and regulatory developments in health care that impacts employers.  As the national voice of large employers, the Business Group also educates and informs policy makers about the perspective and practices of large employers on key health care issues."