September 27, 2022
Robert M. Califf, M.D. (CERTIFIED)
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Nutricia Neocate's False Claim for Removal of Allergenic Corn Proteins
Dear Dr. Califf:
As you are aware, no one has ever successfully removed allergenic food proteins, [1] thereby rendering allergens hypoallergenic. This is the reason that strict avoidance of allergens is always advised. [2]
One of the primary reasons I became a full-time corn allergy advocate was based on the heartbreaking testimonies from parents of corn-allergic infants. There are no commercially manufactured corn-free formulas available for corn-allergic infants, and many of these parents have had to resort to nourishing these struggling babies with milk from camels or goats. If the mother is nursing, she must adhere to a strict corn-free diet which is very difficult, since corn is ubiquitous and is exempt from FDA labeling requirements. If corn-allergic babies require treatment at a medical facility, they are not equipped to safely treat/nourish corn-allergic infants.
Nutricia Neocate's False Claim for Removal of Allergenic Corn Proteins
For the protection of corn-allergic infants, I am appealing to the FDA to immediately investigate the following false and misleading claim on their website. Corn syrup produced from allergenic cornstarch, [3] and any other corn-derived substance, can prove FATAL [4] to anyone with an IgE-mediated allergy to corn due to the presence of allergenic corn proteins.
“CAN CORN SYRUP ELICIT AN ALLERGIC REACTION FROM MY CHILD WITH FOOD ALLERGIES?
Neocate ingredients (e.g. amino acids, oils, carbohydrates) are carefully chosen with strict criteria to help ensure there is no allergenic risk. All corn ingredients in Neocate undergo a strict refining process designed to remove the protein and fat that are naturally present in corn. Since the protein part of the food is what the body responds to in a typical allergic reaction, the removal of corn protein takes away this potential trigger. [emphasis added]
Leading experts in allergy management say that corn syrup is tolerated by individuals with corn allergies.1 Refined corn syrup is generally not restricted in the diets of individuals with corn allergies.“ [emphasis added]
https://www.neocate.com/living-with-food-allergies-blog/corn-syrup-solids
[Their cited reference makes no mention of corn syrup.]
"Leading experts in allergy management say that corn syrup is tolerated by individuals with corn allergies."
https://pubmed.ncbi.nlm.nih.gov/23384028/
Dr. Califf, for the safety of corn-allergic babies, please investigate this false and misleading claim by Nutricia Neocate.
Sincerely,
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyinitiative@gmail.com
Twitter: @CornAllergy911
References:
[1] Removing Allergenic Food Proteins Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html
[2] STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED
https://cornallergyadvocacyresources.blogspot.com/2020/05/strict-avoidance-of-allergens-is-always.html
[3] "Corn-Free Diet," Golisano Children's Hospital, Pediatric Nutrition
https://www.urmc.rochester.edu/childrens-hospital/nutrition/corn-free.aspx
"Dextrose-containing solutions pose a significant risk to patients allergic to corn. Dextrose used for IV fluids is prepared by the simple hydrolysis of cornstarch." [emphasis added]
https://journals.lww.com/anesthesia-analgesia/Fulltext/2019/05000/Excipients_in_Anesthesia_Medications.11.aspx
Corn Allergy Food List
https://www.leavesoflife.com/blog/corn-allergy-food-list?rq=corn%20allergy
[4] Corn Allergy Symptoms: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/11/corn-allergy-symptoms-personal.html
