My August 5, 2022, Certified Letter to the FDA Commissioner Re: Dextrose (Corn Sugar/D-Glucose) is Not Naturally Present in Any Living Organism

 August 5, 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

Dear Dr. Califf:

As you are aware, dextrose is the chemical name for corn sugar produced from cornstarch/D-glucose pursuant to 21CFR184.1857. [1]  Therefore, any food or drug/biologic product containing added dextrose can prove fatal to anyone with an IgE-mediated allergy to corn due to the presence of allergenic corn proteins.  It is for this reason that corn sugar (dextrose/D-glucose)-containing IV fluids are contraindicated for administration to corn-allergic patients in the package insert. [2]

Many of the 17K+ members in our corn allergy support groups are corn-allergic clinicians, and they have expressed grave concern that they were never taught that dextrose is corn sugar produced from cornstarch/D-glucose in their respective disciplines; i.e., they were taught that dextrose is "sugar water."  As a result, the primary complaint by our members addresses clinicians telling corn-allergic patients: "You cannot be allergic to dextrose, since dextrose is naturally present in humans."  Of course, it is impossible for corn sugar produced from cornstarch (dextrose/D-glucose) to be naturally present in any living organism; and it is impossible for corn or any substance derived from corn (an IgE-mediated allergen for thousands of individuals) to be naturally present in the human body.

    Glucose = blood sugar essential for the survival of all living organisms
    D-Glucose = laboratory-created form of sugar produced from cornstarch (dextrose)
    L-Glucose = laboratory-created form of sugar

In an effort to protect the lives of corn-allergic citizens, we are requesting confirmation from the FDA, in writing, that dextrose (corn sugar produced from cornstarch/D-glucose) is only produced from cornstarch (many websites are falsely claiming it can be derived from wheat) and is not naturally present in humans or in any other living organism.  We can then share the FDA's written confirmation with our clinicians, as well as food manufacturers claiming that their products are free from corn even though the product contains added dextrose (corn sugar produced from cornstarch/D-glucose).  Corn-allergic citizens should not be required to educate our clinicians or food manufacturers in an effort to guarantee our safety. 

Since corn allergies are increasing at an alarming rate (1,128.0% in the last 108 months), [3] the FDA's written confirmation is critical for the safety of corn-allergic patients and consumers.  

On behalf of corn-allergic citizens, we look forward to hearing from you.

Sincerely,

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyinitiative@gmail.com
Twitter: @CornAllergy911

References:

[1] Code of Federal Regulation 21CFR184.1857

Sec. 184.1857 Corn sugar.

"(a) Corn sugar (C6H12O6, CAS Reg. No. 50-99-7), commonly called D-glucose or dextrose, 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 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

[2] "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."
https://journals.lww.com/anesthesia-analgesia/Fulltext/2019/05000/Excipients_in_Anesthesia_Medications.11.aspx

[3] 2nd Quarter, 2022, Corn Allergy Statistics
In one corn allergy group of 12,280 members, the growth in membership represents a 1,128.0% increase in corn allergies in the last 108 months with an average of 104.4 new members/month.
https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Additional References:

"Corn must first be converted to corn sugar (dextrose, the common commercial name for D-glucose) . . ."
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/

Over a period of many decades, the "D-" modifier has been shortened to "glucose" for convenience purposes. Dextrose (D-glucose/corn sugar) is not naturally present in humans, and can prove fatal to individuals with an IgE-mediated allergy to corn.
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf

"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

The European Medicines Agency also confirms dextrose is ONLY derived from corn.
"Dextrose a sugar that is obtained from corn starch"
"Dextrans come from corn and potato starch; dextrose comes from corn."
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf

Wikipedia is intentionally endangering the lives of corn-allergic citizens; e.g. if you reference "dextrose" (corn sugar produced from cornstarch), you will be redirected to "glucose" (blood sugar). Dextrose (corn sugar) is NOT naturally present in humans.
https://en.wikipedia.org/wiki/Glucose

“Dextrose is an ALL-American sugar, derived from American corn, refined in American factories, distributed by American companies.”
FACT: Dextrose can prove FATAL to anyone w/an IgE-mediated allergy to corn.
https://candyprofessor.wordpress.com/2010/09/29/dextrose-all-american-corn-sugar/

My December 14, 2021, Email to the Board of Trustees, American Medical Association (AMA) Re: Dextrose (Corn Sugar) / Conflicting Molecular Formulas
https://cornallergyadvocacyresources.blogspot.com/2021/12/my-december-14-2021-email-to-board-of.html

Guidelines for reporting clinicians who administer corn sugar (dextrose/D-glucose)-containing IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

My September 29, 2020, Email to Baxter Healthcare Ltd Re: Dextrose IV Fluid
https://cornallergyadvocacyresources.blogspot.com/2020/09/my-september-29-2020-email-to-baxter.html

Peer Review: A Direct Threat to the Safety of Corn-Allergic Citizens [DOCUMENTED]
https://cornallergyadvocacyresources.blogspot.com/2022/03/peer-review-direct-threat-to-safety-of.html