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
Re: Conflicting Molecular Formulas [Documentation will be presented at the end of this letter.]
Dear Dr. Califf:
As a distinguished physician, you are aware of the critical difference between “natural sugars” and “manufactured (added) sugars;” e.g., glucose (molecular formula C6H12O6) is sugar naturally present in all living organisms which is essential for their survival, whereas corn-derived sweeteners produced from allergenic cornstarch (molecular formulas C6H14O7) are not naturally present in any living organism. It is a fact that corn-derived sweeteners are often utilized as a glucose (blood sugar)-elevating agent in many IV fluids; primarily dextrose, which is the chemical name for corn sugar produced from allergenic cornstarch/D-glucose. It is for this reason that these IV fluids are contraindicated for administration to corn-allergic patients in the package insert due to the presence of allergenic corn proteins. You are also aware that there is no “purification process” that effectively removes allergenic proteins from any allergen, which is the reason that strict avoidance of allergens is always advised.
It is apparent that there is a critical typographical error in 21CFR184.1857 that is endangering the lives of corn-allergic citizens. Molecular formula C6H12O6 has been erroneously applied to this CFR which equates corn sugar produced from allergenic cornstarch (dextrose/D-glucose) with glucose (blood sugar naturally present in every living organism). The correct molecular formula should be C6H14O7 to be consistent with all other corn-derived sweeteners produced from allergenic cornstarch. This critical typographical error has led clinicians to tell corn-allergic patients: “You cannot be allergic to dextrose, since dextrose is naturally present in the human body.” This is one of the primary complaints by the 17K+ members in our corn allergy support groups (including from our members who are corn-allergic clinicians). Corn-allergic patients should not be required to educate our clinicians that dextrose is the chemical name for corn sugar produced from cornstarch/D-glucose in our efforts to guarantee our safety. Dextrose (corn sugar produced from allergenic cornstarch/D-glucose) can prove FATAL to anyone with an IgE-mediated allergy to corn, and it can NEVER be naturally present in any living organism.
In an effort to protect the lives of corn-allergic citizens, please advise the appropriate procedure we must follow to request that 21CFR184.1857 be amended to reflect the correct molecular formula, C6H14O7; e.g., citizen’s petition?
In addition, please provide an explanation for the safety of corn-allergic citizens exactly how the FDA arrived at molecular formula C6H12O6 for a sugar that is produced from allergenic cornstarch which can PROVE FATAL to anyone with an IgE-mediated allergy to corn.
Thank you for your attention to the critical matter.
Sincerely,
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyiniitiative@gmail.com
Twitter: @CornAllergy911
DOCUMENTATION:
1. Code of Federal Regulation 21CFR184.1857. The correct molecular formula in this CFR should be C6H14O7 to be consistent with all other corn-derived sweeteners produced from allergenic cornstarch. Dextrose is the chemical name for corn sugar produced from allergenic cornstarch/D-glucose.
Sec. 184.1857 Corn sugar.
"(a) Corn sugar (C6H12O6, [emphasis added] 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 [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
Corn sugar produced from allergenic cornstarch:
Corn sugar = dextrose = D-glucose
Corn sugar = D-glucose = dextrose
Dextrose = corn sugar = D-glucose
Dextrose = D-glucose = corn sugar
D-glucose = corn sugar = dextrose
D-glucose = dextrose = corn sugar
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/
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 corn-allergic citizens.
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf
Corn Sugar Hearings before the Committee on Manufactures, United States Senate, Sixty-Ninth Congress, First Session on S. 481, "A Bill to Amend the Food and Drugs Act." January 7, 1926
Subject: "To Add Corn Sugar to Exceptions in Pure Food and Drugs Act"
". . . that corn sugar is what is chemically known as dextrose, . . ." [emphasis added]
https://babel.hathitrust.org/cgi/pt?id=umn.31951d03669822a&view=1up&seq=3
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
2. Molecular formulas for corn-derived sweeteners produced from allergenic cornstarch should all be consistent.
IMPORTANT NOTE:
Corn syrup is liquid corn sugar produced from cornstarch; therefore, they should be assigned the same molecular formula.
This is exactly how this list appeared on this website in November, 2021, and it was copied directly from the website; however, after I notified the National Library of Medicine with my findings, the corresponding molecular formulas were removed. However, they are clearly noted on the corresponding PubChem documents.
Isoglucose, C6H14O7
Maize Syrup, C6H14O7
Syrup, Maize, C6H14O7
Glucose-Fructose Syrup, C6H14O7
Glucose Fructose Syrup, C6H14O7
Syrup, Glucose-Fructose, C6H12O6
Corn Sugar, C6H12O6
Sugar, Corn, C6H14O7
High-Fructose Maize Syrup, C6H14O7
High Fructose Maize Syrup, C6H14O7
Maize Syrup, High-Fructose, C6H14O7
Syrup, High-Fructose Maize, C6H14O7
https://www.ncbi.nlm.nih.gov/mesh/68066248
Note the following conflicting molecular formulas in this list:
Glucose Fructose Syrup, C6H14O7
Syrup, Glucose-Fructose, C6H12O6
Corn Sugar, C6H12O6
Sugar, Corn, C6H14O7
When I presented this documentation to the NIH National Library of Medicine, they indicated that since this has been the method for identifying corn sugar for many decades, they cannot correct the error at this time since too many published papers would require revision. Therefore, the NIH National Library of Medicine is complicit in propagating the false narrative of equating corn sugar produced from allergenic cornstarch (dextrose/D-glucose) with glucose (blood sugar naturally present in all living organisms which is essential for their survival). It appears they are more concerned with the revision of published papers vs. the safety of corn-allergic citizens.
Wikipedia is intentionally endangering the lives of corn-allergic citizens; e.g. if you reference "dextrose" (corn sugar produced from cornstarch/D-glucose), you will be redirected to "glucose" (blood sugar). Dextrose (corn sugar produced from cornstarch) is D-glucose, NOT glucose (naturally present in humans).
https://en.wikipedia.org/wiki/Glucose
3. Natural Sugars vs. Manufactured (Added) Sugars
It is impossible for corn-derived sweeteners or any other manufactured (added) sugar to be “naturally present” in any living organism.
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
“Nutritive Sweeteners Derived from Corn,” Corn Refiners Association
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf
“Understanding Natural Versus Added Sugars,” UC San Diego School of Medicine
https://chear.ucsd.edu/blog/understanding-natural-versus-added-sugars
“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/
4. Corn sugar produced from cornstarch (dextrose/D-glucose)-containing IV fluids are contraindicated for administration to corn allergic patients in the package insert due to the presence of allergenic corn proteins.
"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
"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 . . ." [emphasis added]
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf
Administering corn sugar (dextrose/D-glucose)-containing IV fluids to a corn-allergic patient is a critical medical error subject to reporting and disclosure, which is equivalent to administering penicillin to a patient with an allergy to penicillin.
https://www.ncbi.nlm.nih.gov/books/NBK2652/
Guidelines for reporting clinicians who administer corn sugar (dextrose/D-glucose)-
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html
5. Removing Allergenic Food Proteins Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html
6. STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED
https://cornallergyadvocacyresources.blogspot.com/2020/05/strict-avoidance-of-allergens-is-always.html
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