Infant Formula Warning Labels Needed

“How traumatic for my child to have to experience a time that should be of comfort and closeness to me, to be so disturbing and painful,” a mother wrote to the FDA. Her 4-month old infant daughter experienced severe gastrointestinal distress and stomach cramping from infant formula supplemented with DHA and ARA oils. This mother learned that DHA/ARA may cause side effects, and her baby’s symptoms disappeared as soon as she switched to a non-DHA/ARA-supplemented formula.

Another mother had a similar experience with her 3-month old infant son. When her son’s diarrhea disappeared as soon as she switched to formula without DHA and ARA, she wrote to the FDA: “Today was the first day in three months that he actually had a firm stool with no sign of diarrhea.” My baby is not an experiment. Mead Johnson should be ashamed of itself for allowing this to happen and the FDA should take responsibility for our health and the health of our children.”

Help us put an end to this unnecessary suffering and write to the FDA Commissioner today.

We need you to speak up for the helpless infants and distressed parents who have suffered long enough. The Cornucopia Institute and the National Alliance for Breastfeeding Advocacy have filed a petition with the FDA, urging them to require a label notice for all infant food products containing the DHA and ARA oils that are causing such painful side effects in some infants. (A sample letter below will help you voice your concerns.)

It is time for the FDA to take responsibility!

Had the distressed parents contacted the formula manufacturers, these mothers would not have been told to switch away from DHA/ARA-supplemented formula. And nowhere on the formula label or websites do the manufacturers warn of the possibility of diarrhea, vomiting and stomach pain.

While many scientists doubt the benefits of manufactured DHA and ARA oils, little doubt exists that at least a subset of the infant population experiences severe side effects, including watery, explosive diarrhea, severe vomiting, and gastrointestinal distress serious complications in this vulnerable population. Manufactured DHA and ARA fatty acids are structurally different from those found naturally in breastmilk. This structural difference may be one of many possible reasons why some infants experience such severe side effects.

Currently, parents have no way of knowing that their infant’s diarrhea, vomiting, or other gastrointestinal pain may be related to the consumption of formula containing these oils. We need your help to pressure the FDA  this is an important issue that needs immediate attention.

Every day that passes without such a clear warning label could mean another day of pain and serious health repercussions for an unlucky infant whose distressed parents or healthcare providers are unaware that a simple switch to a formula without DHA/ARA could relieve symptoms within a day.

Please write to the FDA Commissioner today.

Feel free to use the sample message below or write your own letter or e-mail message based on the information provided in this action alert or in the comprehensive report titled Replacing Mother – Imitating Human Breast Milk in the Laboratory, available at

Send an email message to: [email protected]
or mail your letter to the address in this sample letter:

      Commissioner Andrew von Eschenbach


      Food and Drug Administration


      5600 Fishers Lane


      Rockville, Maryland 20857

Dear Commissioner von Eschenbach,

The FDA has received numerous reports from parents and caregivers of infants who experienced severe side effects from consuming infant formula with DHA and ARA oils. While it appears that most infants tolerate these oils, which are extracted from fermented algae and soil fungus with the use of a toxic petrochemical, some infants experience watery, explosive diarrhea, vomiting, and other gastrointestinal distress. These can be serious complications for a vulnerable population.

The Cornucopia Institute and the National Alliance for Breastfeeding Advocacy have filed a petition with the FDA on January 24, 2008, urging you to revise the labeling requirements for infant formulas that contain DHA and ARA from algal and fungal sources. They specifically request a notice on the label of infant formula with DHA- and ARA-containing oils to warn parents of the possibility of adverse reactions to these novel ingredients.

Given the pain and suffering that some infants are unnecessarily experiencing from the consumption of these oils, I urge you to take immediate action. Formula manufacturers are not warning parents that these oils may cause adverse reactions, and parents of suffering infants, and their healthcare providers, have no way of knowing that switching to a non-DHA/ARA-supplemented formula could relieve symptoms within a day. A simple warning on the label of infant formulas could go a long way in preventing any future suffering of helpless infants.


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