My January 6, 2021, Open Letter to the FDA Re: Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)

REFER TO CRITICAL UPDATES AT THE END OF THIS BLOG POST

Dear FDA:

Re:  Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)

The FDA has made a critical error in 21CFR184.1857, which is endangering the lives of corn-allergic consumers and patients.

Glucose is blood sugar naturally present in all living organisms, and is essential for their survival.  D-glucose is a manufactured, food-derived sugar from cornstarch (dextrose).  Therefore, glucose (blood sugar) and D-glucose (corn sugar/dextrose) cannot be “biochemically identical.”  They may be mirror images of each other; however, like a glove, if you place your hands on top of each other, they are not identical.  Likewise, you cannot fit your right hand into a left-handed glove.  

DOCUMENTED ERRORS:

The FDA is erroneously equating blood sugar present in all living organisms (glucose) with corn sugar manufactured from cornstarch (D-glucose/dextrose). You have assigned the molecular formula for corn sugar manufactured from cornstarch (dextrose/D-glucose) with the same molecular formula for blood sugar present in all living organisms (glucose), C6H12O6.  This would mean that corn sugar manufactured from cornstarch (dextrose/D-glucose) would have to be synthesized to achieve the same molecular formula as blood sugar present in all living organisms (glucose), C6H12O6.  Does the FDA have documentation for this synthesization process? 

The correct molecular formula in 21CFR184.1857 should be C6H14O7.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Blood sugar present in all living organisms (glucose) cannot be equated with D-glucose (corn sugar manufactured from cornstarch/dextrose), since D-glucose (corn sugar) is NOT the same as glucose (blood sugar).  Glucose (blood sugar present in all living organisms) cannot provoke an allergic response; whereas, corn sugar manufactured from cornstarch (dextrose/D-glucose) can prove fatal to individuals with an IgE-mediated allergy to corn.  It is for this reason that IV fluids to which corn sugar (dextrose/D-glucose) has been added are contraindicated for administration to corn-allergic patients in the package insert.

Corn Sugar (Dextrose/D-Glucose) IV Fluids Contraindicated for Corn-Allergic Patients
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

Since D-glucose is the common commercial name for dextrose (corn sugar manufactured from cornstarch), the following molecular formula for D-glucose is also INCORRECT.  

UPDATE

As of December 21, 2020, this was the description for D-Glucose in this PubChem document: [screenshot taken]

"A primary source of energy for living organisms.  It is naturally occurring and is found in fruits and other parts of plants in its free state.  It is used therapeutically in fluid and nutrient replacement."

As of July 3, 2021, this description for D-Glucose was removed, and has now been applied to L-Glucose. In addition, “corn sugar” was correctly added as a Depositor-Supplied Synonym for D-Glucose.
https://pubchem.ncbi.nlm.nih.gov/compound/10954115

D-Glucose, Molecular Formula C6H12O6
[This molecular formula is not only incorrect, it is also inconsistent with the molecular formula for corn syrup and dextrose (see documentation below).]
https://pubchem.ncbi.nlm.nih.gov/compound/5793

UPDATE

After filing a with Drugs.com, they corrected their definition of dextrose; however, another entity has intervened, and Drugs.com continues to endanger the lives of corn-allergic citizens.  The ONLY source of dextrose is corn.

Corn sugar (dextrose/D-glucose) is NOT "produced by the liver" nor is it "glucose" (blood sugar present in all living organisms).  This explains why clinicians continue to endanger the lives of corn-allergic patients if they refer to this false and misleading definition of dextrose (corn sugar/D-glucose).
https://www.drugs.com/dextrose.html

DOCUMENTATION:

"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/

Corn Syrup, Molecular Formula C6H14O7
[Note that corn syrup is corn sugar (dextrose/D-glucose) to which water has been added.]
https://pubchem.ncbi.nlm.nih.gov/compound/5282499

Cornstarch, Molecular Formula C27H48O20
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/24836924

Dextrose, Molecular Formula C6H14O7
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/DEXTROSE

DEXTROSE (CORN SUGAR/D-GLUCOSE) LABELING REQUIREMENTS:

It is our understanding that if dextrose (corn sugar/D-glucose) is an ingredient, the word "dextrose" must appear on the product label; e.g., iodized salt lists "dextrose" as an ingredient. However, they are not required to explain that dextrose is "D-glucose/corn sugar manufactured from cornstarch." If dextrose is required, then dextrose equivalent (DE) should also be required on product labels since they are "one and the same" based on the fact that dextrose equivalent (DE) is only derived from corn. Both can prove lethal to corn-allergic consumers.  Many food retailers, manufacturers, and distributors are confusing dextrin with dextrose, claiming their dextrose products are derived from food sources other than corn.  They are clearly confusing dextrose with dextrin.  

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn.
Corn Sugar (Dextrose/D-Glucose), Code of Federal Regulation 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Confirmation that dextrose equivalent (DE), corn sugar/D-glucose, is only derived from corn.
https://www.austradeinc.com/products/sweeteners/

Confirmation that dextrose (corn sugar/D-glucose) is only derived 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

Dextrin (usually sourced from corn) may be sourced from food products other than corn. Code of Federal Regulation 21CFR184.1277; however, all dextrin products are manufactured with added corn syrup solids.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1277

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn. Dextrin (usually derived from corn) may be derived from food products other than corn.
[Cites food retailers, manufacturers, and distributors who are falsely claiming that dextrose is derived directly from tapioca, which endangers the lives of corn-allergic consumers.]
https://cornallergyadvocacyresources.blogspot.com/2020/12/confirmation-that-dextrose-corn-sugard.html

WHY IS THIS CORRECTION BY THE FDA NECESSARY?

One of the primary complaints in our corn allergy support groups of over 13.5K members [more than double the membership in sesame seed allergy support groups] is that the majority of medical professionals are erroneously equating corn sugar manufactured from cornstarch (dextrose/D-glucose) with blood sugar present in all living organisms (glucose). As a result, they continue to insist upon administering dextrose-containing IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.  Administering corn sugar (dextrose/D-glucose) IV fluids to corn-allergic patients is a critical medical error equivalent to administering penicillin to patients with an allergy to penicillin; therefore, without this critical correction by the FDA, physicians are at risk for potential liability.   We should not be required to educate clinicians for our own safety, and the FDA needs to be more proactive in educating clinicians about the critical difference between glucose (blood sugar) and D-glucose (corn sugar/dextrose).  

In addition, many food retailers, manufacturers, and distributors are claiming their products are corn free; when, in fact, they contain dextrose (or other corn-derived ingredients), which can prove fatal to corn-allergic consumers.  Corn may be exempt from FDA labeling requirements; however, they also risk liability if even one ingredient is derived from corn, yet they claim their products are corn free.  We should not be required to educate food retailers, manufacturers, and distributors for our own safety; e.g., one retailer claimed their product was corn free when, in fact, it contained corn-derived allulose  Thankfully, this manufacturer removed their corn-free claim at our request; since the product could have proven fatal to corn-allergic consumers.  Therefore, the FDA needs to be more proactive in educating food manufacturers regarding corn-derived ingredients. 

Many clinicians, food retailers, manufacturers, and distributors are falsely equating blood sugar present in all living organisms (glucose) with corn sugar (dextrose/D-glucose) based on these erroneous and conflicting molecular formulas; and, as a result, the lives of corn-allergic consumers and patients remain in constant danger.  

WHAT ARE OUR OPTIONS FOR EFFECTING THESE CRITICAL CORRECTIONS?

I, on behalf of the corn allergy community, would like to send a certified letter to the responsible party or agency exposing these critical errors with a request that these errors be corrected immediately.  Please provide me with the applicable contact information for directing my certified letter.

I have already provided indisputable documentation to the NIH National Library of Medicine; however, they are adamant that blood sugar present in all living organisms (glucose) is "one and the same" with corn sugar manufactured from cornstarch (dextrose/D-glucose).  They do not understand the critical difference between glucose (blood sugar) and D-glucose (corn sugar/dextrose).  In addition, they are ignoring the molecular formula assigned to dextrose and corn syrup (C6H14O7) that is documented in their own database.

Thank you very much for your attention to this critical concern.

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

Additional References:

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

Corn Allergen Lists of Corn Products/Corn-Derived Ingredients to be Avoided

https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

Corn Allergy References, Surveys, Studies (“. . . Maize major allergen . . .”), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

 

IMMEDIATE CORRECTION REQUIRED BY THE FDA:

Critical error discovered in 21CFR182.1866 (a), which endangers the lives of corn-allergic consumers/patients. 

21CFR182.1866 (a), High fructose corn syrup

The FDA is erroneously equating blood sugar present in all living organisms (glucose) with corn sugar manufactured from cornstarch (dextrose/D-glucose) in this CFR. 

(a) ". . . conversion of glucose (dextrose) to fructose . . ."

Since dextrose is defined as corn sugar manufactured from cornstarch/D-glucose in 21CFR184.1857, the FDA must correct this statement to read:

(a) ". . . conversion of corn sugar (dextrose) to fructose . . ."

https://www.govinfo.gov/content/pkg/CFR-1996-title21-vol3/html/CFR-1996-title21-vol3-sec182-1866.htm

Corn Sugar (Dextrose/D-Glucose), Code of Federal Regulation 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

"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/

Updated March 6, 2024:

Glucose (natural) vs. D-Glucose (synthetic)
D-Glucose can prove fatal to corn-allergic consumers/patients.
https://glucosenaturalvsdglucosesynthetic.quora.com/

Blog Post Reference Link:

My January 6, 2021, Open Letter to the FDA Re: Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)
https://cornallergyadvocacyresources.blogspot.com/2021/01/my-january-6-2021-open-letter-to-fda-re.html