I mailed 11 topic-specific certified letters to the FDA Commissioner in August/September, 2022, for the protection of corn-allergic citizens. I was advised by the FDA that they are under no obligation to answer these letters. Instead, they instructed us to file a Citizen's Petition with our concerns. A Citizen's Petition requires documented evidence.
Regarding clinicians who tell corn-allergic patients that "dextrose is naturally present in our bodies." I have been respectfully interviewing all of my clinicians on the subject of "dextrose," and I encourage each of our members to respectfully interview your own clinicians. Their answers to the following questions will be included in our Citizen's Petition.
IMPORTANT NOTE: Before interviewing my clinicians, I advise them that the FDA has instructed us to file a Citizen's Petition; and their answers to these questions will be included in our petition.
Sample of My Interview Questions:
I begin my interviews as follows: As my personal clinician, it is important that I understand your definition of "dextrose."
1. What is your definition of dextrose?
If they answer "glucose," my reply is: "Glucose is blood sugar naturally present in all living organisms that is essential for their survival; therefore, is it your understanding that dextrose is naturally present in the human body?"
If they answer "yes" to this question, my next question is:
2. Are you aware that dextrose-containing IV fluids are contraindicated for administration to corn-allergic patients in the package insert?
If they answer "no" to this question, I then explain to them that dextrose is the chemical name for corn sugar produced from cornstarch/D-glucose pursuant to Code of Federal Regulation 21CFR184.1857. Dextrose (corn sugar)-containing IV fluids (utilized as a glucose (blood sugar)-elevating agent) contain allergenic corn proteins that can prove fatal to patients with an IgE-mediated allergy to corn.
At this point, I present my clinicians with the following documentation for my protection. So far, they have all been very receptive and appreciative of the documentation I present to them.
If “Dextrose” is referenced on the FDA’s Food Additive Status List, it refers to 21CFR184.1857.
https://www.fda.gov/food/food-additives-petitions/food-additive-status-list#ftnD
If 21CFR184.1857 is referenced, the definition is “Corn sugar” produced from cornstarch, a/k/a dextrose/D-glucose
Code of Federal Regulation 21CFR184.1857
Sec. 184.1857 Corn sugar.
(a) Corn sugar . . . commonly called D-glucose or dextrose, [emphasis added] is the chemical [alpha]-D-glucopyranose. It occurs as the anhydrous or the monohydrate form and is produced by the complete hydrolysis of corn starch [emphasis added] with safe and suitable acids or enzymes, followed by refinement and crystallization from the resulting hydrolysate.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
"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."
"Pharmacists are requested to use caution and be aware that many drugs and medications contain undisclosed potential allergens in the form of sugars, starches, and celluloses. Share the corn allergy example with prescribers . . ."
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf
3. Were you taught in your respective disciplines that glucose and D-glucose are "one and the same?"
If they answer "yes" to this particular question, I present them with the following documentation:
Dextrose (corn sugar produced from cornstarch) is D-glucose, 21CFR184.1857 – NOT glucose.
Glucose = blood sugar naturally present in all living organisms that is essential for their survival.
D-Glucose = synthetic, laboratory-created form of sugar produced from cornstarch (dextrose), 21CFR184.1857, that is utilized as a glucose (blood sugar)-elevating agent in many IV fluids; enantiomer of L-glucose and isomer of glucose. D-glucose (corn sugar produced from cornstarch/dextrose) can prove fatal to individuals with an IgE-mediated allergy to corn.
L-Glucose = synthetic, laboratory-created form of sugar; enantiomer of D-glucose and isomer of glucose.
What is glucose?
https://www.webmd.com/diabetes/glucose-diabetes
HOW DO GLUCOSE-ELEVATING AGENTS WORK?, RxList
https://www.rxlist.com/glucose-elevating_agents/drug-class.htm
"Corn must first be converted to corn sugar
(dextrose, the common commercial name for D-glucose) . . ." [emphasis
added]
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/
STARCH FOUND IN CORN
"After the starch is completely hydrolyzed or broken
down its basic component is d-glucose also called dextrose or corn sugar."
[emphasis added]
Pg. 13
When . . dextrose [corn sugar] molecules . . . are broken
by the chemical addition of water . . . The ultimate product . . . is a . . .
sugar called D-glucose or dextrose. [emphasis added]
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf
Additional questions you can ask your clinicians during your interviews:
1. Were you taught in your respective disciplines that dextrose is corn sugar produced from cornstarch?
2. Were you taught in your respective disciplines that dextrose is naturally present in the human body?
3. Did you ever tell a corn-allergic patient that it is impossible to be allergic to dextrose?
4. If a patient experiences an anaphylactic reaction to dextrose-containing IV fluids, is the patient's reaction listed as idiopathic or is their reaction attributed to an allergic reaction to corn?
PLEASE EMAIL ME (cornallergyinitiative@gmail.com) WITH THE RESULTS OF YOUR INTERVIEWS FOR INCLUSION IN OUR CITIZEN'S PETITION TO THE FDA. Your personal names will be protected, and only your initials will be published. Your country of residence is also required.
ALL QUESTIONS AND/OR CONCERNS REGARDING THIS SURVEY MUST BE SENT TO MY EMAIL ADDRESS: cornallergyinitiative@gmail.com.
For the safety of corn-allergic patients, thank you very much for participating in this critical survey.
https://cornallergyadvocacyresources.blogspot.com/
My Certified Letters [11] to the FDA
Commissioner on Behalf of Corn-Allergic Consumers/Patients
[Dextrose is the chemical name for
corn sugar produced from cornstarch, 21CFR184.1857.]
