Friday, August 12, 2022

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



My August 5, 2022, Certified Letter to the FDA Commissioner Re: HFCS (Essential for Human Survival?)

 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:  The FDA is implying that consuming HFCS is essential for our survival!

Dear Dr. Califf:

The FDA declares in this article that HFCS (made from cornstarch) is ". . . essentially 100% glucose." [emphasis added]  Glucose is blood sugar naturally present in all living organisms, and is essential for their survival.  Therefore, the FDA is implying that consuming HFCS is essential for our survival.
https://www.fda.gov/food/food-additives-petitions/high-fructose-corn-syrup-questions-and-answers 

This article should read:  ". . . essentially 100% D-glucose." [emphasis added]

    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

Sugars that are produced from cornstarch (dextrose/D-glucose) can never be naturally present in the human body, and must never be equated with glucose (blood sugar).

CRITICAL CORRECTION REQUIRED IN 21CFR182.1866

The following critical error was discovered in 21CFR182.1866 (a), which endangers the lives of corn-allergic citizens.

21CFR182.1866 (a), High Fructose Corn Syrup

"Sec. 182.1866 High fructose corn syrup

(a) Product. High fructose corn syrup is a sweet, nutritive saccharide mixture containing approximately 52 percent (dry weight) glucose, 43 percent (dry weight) fructose, and 5 percent (dry weight) other saccharides. It is prepared as a clear aqueous solution from high dextrose equivalent corn starch hydrolysate by partial enzymatic conversion of glucose (dextrose) [emphasis added] to fructose utilizing an insoluble glucose isomerase enzyme preparation described in Sec. 184.1372 of this chapter."
https://www.govinfo.gov/content/pkg/CFR-1996-title21-vol3/html/CFR-1996-title21-vol3-sec182-1866.htm

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

(a) ". . . conversion of glucose (dextrose) [emphasis added] 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:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

". . . conversion of corn sugar (dextrose) to fructose , . ." —OR—

". . . conversion of D-glucose (dextrose) to fructose  . ."

Both of the following references require correction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1866

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


Dr. Califf, for the safety of corn-allergic citizens, your immediate attention is requested in this critical matter.  

Sincerely,


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


Reference:

The FDA is implying that consuming HFCS is essential for our survival! / Quora Surveys
https://cornallergyadvocacyresources.blogspot.com/2021/06/the-fda-is-implying-that-consuming-hfcs.html

My August 5, 2022, Certified Letter to the FDA Commissioner Re: Source of Xanthan Gum, D-Mannose, and D-Glucuronic Acid

 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:  Source of Xanthan Gum, D-Mannose, and D-Glucuronic acid

Dear Dr. Califf:

Based on the testimonies from the 17K+ members in our corn allergy support groups reacting to xanthan gum, we require confirmation from the FDA, in writing, to present to food manufacturers related to the "source" of xanthan gum, D-Mannose, and D-Glucuronic acid; since many food manufacturers are claiming that the xanthan gum in their products is derived from sources other than corn.  My own reaction to xanthan gum is swift and severe due to my IgE-mediated allergy to corn, since xanthan gum contains allergenic corn protein.

The NIH National Library of Medicine, PubChem CID 131750926, clearly defines xanthan gum as "Corn sugar gum."
https://pubchem.ncbi.nlm.nih.gov/compound/131750926

Code of Federal Regulation 21CFR172.695
Sec. 172.695 Xanthan gum.
"The food additive xanthan gum may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a polysaccharide gum derived from Xanthomonas campestris by a pure-culture fermentation process and purified by recovery with isopropyl alcohol. It contains D-glucose, [emphasis added] D-mannose, and D-glucuronic acid as the dominant hexose units and is manufactured as the sodium, potassium, or calcium salt."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=172.695

    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

Therefore, it appears the only source of xanthan gum is corn sugar produced from cornstarch (D-glucose), 21CFR184.1857.

Code of Federal Regulation 21CFR185.1857

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


Re: D-mannose and D-glucuronic acid

We would also appreciate confirmation from the FDA, in writing, confirming the source of these substances.

On behalf of corn-allergic citizens, we appreciate your attention to this critical matter.


Sincerely,


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





My August 5, 2022, Certified Letter to the FDA Commissioner Re: Source of Ascorbic Acid (Synthetic, Laboratory-Created Vitamin C)

 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: Source of Ascorbic Acid (Synthetic, Laboratory-Created Vitamin C)

Dear Dr. Califf:

During my hospitalization, I suffered a severe hypoglycemic episode due to the fact that I have an IgE-mediated allergy to corn; therefore, straight saline-only IV fluids were administered to me.  I was then given orange juice to drink; however, this required an antihistamine to be injected through my IV, since the orange juice contained corn-derived ascorbic acid (synthetic, laboratory-created Vitamin C).  My allergy to corn was clearly documented in my medical records; however, the hospital staff still gave me orange juice which contained my allergen (corn).  Why did my attending clinicians not know that ascorbic acid is synthetic Vitamin C that is usually derived from corn?  If I was anaphylactic to corn, this oversight could have proven fatal to me.

In an effort to protect the lives of corn-allergic citizens, I would recommend that the FDA correct the following Food Additive Status List reference.  In addition, it is of critical importance that the source of the synthetic Vitamin C be clearly indicated within the FDA's Codes of Federal Regulation.

    From:  Vitamin C - See Ascorbic Acid

    To:  Vitamin C - See Ascorbic Acid (synthetic Vitamin C)


Documentation:

1. Code of Federal Regulation 21CFR182.3013

Subpart D - Chemical Preservatives [emphasis added]

Sec. 182.3013 Ascorbic acid.

(a) Product. Ascorbic acid.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.3013


2. Name of Material: "Ascorbic Acid"

Is this substance Natural or Synthetic?  Explain (if appropriate)

    "Synthetic compound because of its extraction and purification using synthetic acidulants."
https://www.ams.usda.gov/sites/default/files/media/Ascorbic%20Acid%20TR.pdf


3. Code of Federal Regulation 21CFR184.8013

"Subpart 1 - Nutrients [emphasis added]

Sec. 182.8013 Ascorbic acid.
(a) Product. Ascorbic acid."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.8013

4. All About Where Vitamin Supplements Come From, By Ryan Andrews, MS, MA, RD, RYT, CSCS

"When a vitamin is marked “natural”, it only has to include 10% of actual natural plant-derived ingredients. The other 90% could be synthetic.

Most vitamin C currently manufactured is synthetic, coming from China. Vitamin C is a weak acid. Many supplements use salt forms (sodium ascorbate, calcium ascorbate, magnesium ascorbate) to decrease acidity.

The most popular form of synthetic vitamin C is ascorbic acid. [emphasis added]  Naturally occurring vitamin C is the same molecule as synthetic ascorbic acid. But in food, ascorbic acid is found within the vitamin C complex among other compounds. The ascorbic acid in supplements is often derived from corn starch, corn sugar, or rice starch, and is chemically dependent upon volatile acids." [emphasis added]
https://www.precisionnutrition.com/all-about-vitamin-supplements?fbclid=IwAR2LLGs6-KnEfVL-7vqcSQrnIs1987pz-CtePo5B57qLJP66gqaG3N1Yhzs


5. "According to an article in The Healthy Home Economist, ascorbic acid is actually synthetic vitamin C, usually derived from GMO corn. [emphasis added]  And, there is a growing body of evidence that those consuming high doses of ascorbic acid should have reason to worry."
https://www.northcoast.organic/beware-ascorbic-acid-synthetic-vitamin-c/?


6. "Over 90% of ascorbic acid in this country is manufactured at a facility in Nutley, New Jersey, owned by Hoffman-LaRoche, one of the world’s biggest drug manufacturers (1 800 526 0189). Here ascorbic acid is made from a process involving cornstarch and volatile acids. [emphasis acid]  Most U.S. vitamin companies then buy the bulk ascorbic acid from this single facility. After that, marketing takes over. Each company makes its own labels, its own claims, and its own formulations, each one claiming to have the superior form of vitamin C, even though it all came from the same place, and it’s really not vitamin C at all."
https://www.justlivewell.com/whole-food-vitamins-ascorbic-acid-is-not-vitamin-c/


Dr. Califf, since my acute hypoglycemic episode caused delirium, I was unable to alert the attending clinicians that they must first verify the source of each and every ingredient in any juice and/or food product with the manufacturer to verify the presence of corn-derived ingredients due to the fact that corn is exempt from FDA labeling requirements.

This is a common complaint by the 17K+ members in our corn allergy support groups (more than double the membership in sesame seed allergy support groups).  We would like an explanation as to why we are frequently offered foods, fluids, and drug/biologic products containing corn-derived ingredients when our IgE-mediated allergy to corn is clearly documented in our medical records.

On behalf of corn-allergic citizens, we would appreciate your reply to this critical concern.  Corn-allergic patients should not be required to educate our clinicians that ascorbic acid is synthetic Vitamin C that is usually derived from corn (our allergen).

Sincerely,


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



My August 5, 2022, Certified Letter to the FDA Commissioner Re: Conflicting Molecular Formulas

 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)-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


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





My August 5, 2022, Certified Letter to the FDA Commissioner Re: Ciranda "Tapioca Dextrose" (Acute Allergic Reaction Reported to the FDA)

 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: Ciranda "Tapioca Dextrose" (Acute Allergic Reaction Reported to the FDA)

Dear Dr. Califf:

As you are aware, dextrose is corn sugar produced from cornstarch pursuant to 21CFR184.1857 [1] that can prove fatal to anyone with an IgE-mediated allergy to corn.  It is for this reason that 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. [2]  Therefore, there is no such thing as "tapioca dextrose."  It is tapioca starch to which corn sugar produced from cornstarch (dextrose/D-glucose) has been added to the product, since it is impossible to derive corn sugar produced from cornstarch (dextrose/D-glucose) from the tapioca plant. 

Following is the false advertising of this product that endangers the lives of corn-allergic consumers:

"Tapioca Dextrose, Organic tapioca dextrose (glucose) . . ." [emphasis added]
https://www.ciranda.com/ingredients/syrups-sweeteners/tapioca-dextrose/tapioca-dextrose

Dextrose is D-glucose — not glucose; however, they are equating D-glucose (corn sugar produced from cornstarch/dextrose) with glucose (blood sugar essential for the survival of all living organisms).  Humans do not have corn sugar produced from cornstarch (dextrose/D-glucose) naturally present in our bodies.

    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


Acute Allergic Reaction to this Product:

After I was made aware that some companies were selling "tapioca dextrose," I elected to conduct an oral challenge of the subject product for the safety of corn-allergic consumers, and suffered an acute allergic reaction.

[I strongly recommend against conducting an oral food challenge unless the patient is in the presence of their physician.  Although I have not yet experienced an anaphylactic reaction to corn, I did have epinephrine auto-injector pens available.]


November 19, 2020:  Oral challenge requiring 2 antihistamines and 2 prednisone tablets.

After reporting my acute, 8-hour allergic reaction (consumed 1 level tsp.) of this mislabeled food product to my FDA state consumer complaint coordinator with indisputable documentation this product was mislabeled, they told me they sent my complaint back to the FDA's Center for Food Safety and Applied Nutrition; even though I supplied them with the requisite documentation of my severe allergic reaction to "Organic Tapioca Dextrose" from a complimentary sample sent to me by Ciranda.  It was actually tapioca starch to which corn sugar produced from cornstarch (dextrose/D-glucose) was added.  The FDA has done nothing to address this critical issue.

NOTE:  I still have the product available for inspection and testing by the FDA (one package remains unopened), and Ciranda continues to falsely advertise "Tapioca Dextrose."


Dr. Califf, I have personally forwarded indisputable documentation to all companies advertising "tapioca dextrose."  Since this is false and misleading, several companies removed their deceptive advertising; however, for the safety of corn-allergic consumers, I believe the FDA should forward an industry-wide notification confirming that dextrose (corn sugar produced from cornstarch/D-glucose) cannot be derived from the tapioca plant or any other food product other than corn.

On behalf of corn-allergic citizens, I thank you for investigating this critical matter.

Sincerely,


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyiniitiative@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


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

My August 5, 2022, Certified Letter to the FDA Commissioner Re: Mike's Mix "Tapioca Dextrose"

 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: Mike's Mix "Tapioca Dextrose"

Dear Dr. Califf:

As you are aware, dextrose is corn sugar produced from cornstarch pursuant to 21CFR184.1857 [1] that can prove fatal to anyone with an IgE-mediated allergy to corn.  It is for this reason that 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. [2]  Therefore, there is no such thing as "tapioca dextrose."  It is tapioca starch to which corn sugar produced from cornstarch (dextrose/D-glucose) has been added, since it is impossible to derive corn sugar produced from cornstarch (dextrose/D-glucose) from the tapioca plant. 

Following is the false advertising of this product that endangers the lives of corn-allergic consumers:

    1.  "Dextrose is synonymous with D-glucose or simply glucose . . ."

Dextrose is, in fact, D-glucose; however they are equating D-glucose (corn sugar produced from cornstarch/dextrose) with glucose (blood sugar essential for the survival of all living organisms).  Humans do not have corn sugar produced from cornstarch (dextrose/D-glucose) naturally present in our bodies.

    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

    2.  "This product is gluten free and contains no corn [emphasis added] or wheat and is vegetarian and vegan. No artificial sweeteners or colorings of any sort. Only one ingredient: Pure Tapioca Dextrose." [emphasis added] 
https://mikesmixture.com/products/tapioca-dextrose

This product does, in fact, contain corn sugar produced from cornstarch (dextrose/D-glucose) that can prove fatal to anyone with an IgE-mediated allergy to corn.

I have personally provided this company with indisputable documentation that their product is not free from corn; however, they refuse to correct these false statements.

Dr. Califf, for the safety of corn-allergic citizens, I am appealing to you to investigate this company's false and misleading claims with a demand that they immediately correct these false statements.

On behalf of corn-allergic citizens, I thank you for investigating this critical matter.

Sincerely,


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyiniitiative@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

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 Ave...