My October 20, 2020, Email to the ACAAI Re: Directive from the FDA Addressing the ACAAI’s Claims Regarding Corn Allergenic Proteins

UPDATE DECEMBER 10, 2021:  The ACAAI is once again intentionally endangering the lives of corn-allergic infants.  

UPDATE FEBRUARY 20, 2021:  We are grateful that the ACAAI has suspended this page on their website.  However, we have also appealed to them to suspend the following page, since it clearly endangers the lives of corn-allergic infants.

“Infant Formulas and Corn Allergy”
https://acaai.org/resources/connect/ask-allergist/infant-formulas-and-corn-allergy

*******************************

[Note that it has been nearly four months since I sent the following email to the ACAAI, and they have not yet complied with the FDA’s directive addressing this issue.]

Please note that the FDA instructed me to contact the ACAAI directly to obtain "information about the testing procedures used to justify their claims" related to the absence of corn protein in “Most corn derived products, like high-fructose corn syrup,” Case Number 247714

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response to the following submitted inquiry:

My Inquiry to the FDA:

The ACAAI specifically declares:  "Most corn-derived products, like high-fructose corn syrup, do not contain corn protein."
https://acaai.org/allergies/types/food-allergies/types-food-allergy/corn-allergy

Since the majority of the 12K+ members in our corn allergy support groups react to corn syrup (and just about every other product derived from corn), we would like to know what testing method is utilized to confirm that “Most corn-derived products, like high-fructose corn syrup, do not contain corn protein.”  Thank you.

Reply from the FDA, Case #247714:

"Response: Case Number 247714

Dear Sir/Madam:

Thank you for your inquiry regarding allergens in corn-derived products. You noted a statement from the ACAAI about allergen levels in such products.

There is no collaboration between FDA and the ACAAI, and FDA does not have records pertaining to their claims. Please contact the ACAAI for information about the testing procedures used to justify their claims. (emphasis added)

We hope this information is helpful. Please contact us if you have further questions.

Thank you for contacting FDA’s FCIC/TAN."

 

Therefore, for the benefit and safety of consumers with an IgE-mediated allergy to corn; will you kindly share the information about the testing procedures used to justify your claims.

Thank you very much.

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

 

Additional References:

My March 27, 2018, Certified Letter to the ACAAI  Re: Cornstarch and Corn Syrup
https://cornallergyadvocacyresources.blogspot.com/2018/03/my-march-27-2018-certified-letter-to.html

[Note: The ACAAI did redact their false claim regarding cornstarch; however, we have continued to appeal to them to redact their equally false claim regarding HFCS.]

Petition to Demand that the ACAAI Remove False Statement Re: Cornstarch/High-Fructose Corn Syrup
https://cornallergyadvocacyresources.blogspot.com/2018/02/petition-to-demand-that-acaai-remove.html

Argo Cornstarch Oral Challenge to Test Hypothesis Presented by the ACAAI
[Conclusion: If you are allergic/intolerant to corn, do NOT consume cornstarch. I suffered a significant allergic reaction as a result of this oral challenge.]
https://cornallergyadvocacyresources.blogspot.com/2018/03/argo-cornstarch-oral-challenge-to-test.html

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html

STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED
https://cornallergyadvocacyresources.blogspot.com/2020/05/strict-avoidance-of-allergens-is-always.html

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines
https://cornallergyadvocacyresources.blogspot.com/2020/05/my-april-20-2020-email-to-childrens.html

"Corn Allergy Food List"
https://www.leavesoflife.com/corn-allergy-food-list/?fbclid=IwAR1v_17JjwBItTzKGX9NcGwSpiwC_3Hgggq6mYQawQOlrdQWfn8vm18nB_4

 

Blog Post Reference

My October 20, 2020, Email to the ACAAI Re: Directive from the FDA Addressing the ACAAI’s Claims Regarding Corn Allergenic Proteins
https://cornallergyadvocacyresources.blogspot.com/2021/02/my-october-20-2020-email-to-acaai-re.html

August 29, 2020, Email to the National Library of Medicine Re: Depositor-Supplied Synonyms in PubChem Documents; e.g., Grape Sugar

What standards does the NIH National Library of Medicine apply to "Depositor-Supplied Synonyms" in PubChem documents?  Let's use "grape sugar" as an example.

A quick search on Google for grape sugar has numerous erroneous and legitimate definitions for the source of this sugar.  It appears that the National Library of Medicine has opted for using the erroneous definitions for inclusion in PubChem documents.

CRITICAL REMINDER:  It is impossible for dextrose (corn sugar manufactured from cornstarch) to be found naturally in any food/drug/biologic product.  Dextrose is corn sugar that is ADDED TO these products.  Therefore, it is impossible for corn sugar (dextrose) to be naturally present in grapes/grape sugar.

Does the public have the right to request the "source" of the "Depositor-Supplied Synonym" from the National Library of Medicine for "grape sugar" that is listed in PubChem CID 79025?

https://pubchem.ncbi.nlm.nih.gov/compound/79025#section=Depositor-Supplied-Synonyms

I have personally supplied the National Library of Medicine with the Code of Federal Regulation 21CFR184.1857 which documents that dextrose is corn sugar. However, corn sugar is not included in the list of "Depositor-Supplied Synonyms" on either PubChem CID 79025 or PubChem CID 66370.

https://pubchem.ncbi.nlm.nih.gov/compound/79025#section=Depositor-Supplied-Synonyms

https://pubchem.ncbi.nlm.nih.gov/compound/Dextrose#section=Synonyms

Conclusion:

Based on this documentation, it is my personal opinion that the National Library of Medicine is complicit in propagating the false narrative about the source of dextrose (corn sugar manufactured from cornstarch) on behalf of the corn industry with no regard for the safety of corn-allergic consumers and patients.

Diane H. Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References:

CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Dextrose: Facts vs. Fiction

https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

Additional References

My August 29, 2020, Email to the FDA and the NIH National Library of Medicine Re: Immediate Revision of PubChem Documents Equating Glucose (Blood Sugar) with Dextrose (Corn Sugar)

https://cornallergyadvocacyresources.blogspot.com/2020/08/august-29-2020-email-to-fda-and-nih.html

My July 2, 2020, Appeal to the NIH National Library of Medicine Re: PubChem CID 79025, Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Derived from Cornstarch)
https://cornallergyadvocacyresources.blogspot.com/2020/07/my-july-2-2020-appeal-to-nih-national.html

The NIH National Library of Medicine cites Wikipedia 9 times:
Is it usual and customary for government agencies to cite Wikipedia in official government publications?

https://pubchem.ncbi.nlm.nih.gov/compound/Inositol#section=DSSTox-Substance-ID

"Wikipedia:Wikipedia is not a reliable source"
https://en.wikipedia.org/wiki/Wikipedia:Wikipedia_is_not_a_reliable_source#:~:text=Wikipedia%20can%20be%20edited%20by,progress%2C%20or%20just%20plain%20wrong.&text=Therefore%2C%20Wikipedia%20should%20not%20be,source%20in%20and%20of%20itself.

Corn Allergy: A Potentially Life-Threatening Diagnosis

https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

July, 2020, Month-End Corn Allergy Statistics: 949.9% Increase in 85 Months

(Corn is ubiquitous and is EXEMPT from FDA labeling requirements, resulting in underreporting and suppression of corn allergy statistics).

https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Corn Allergy References, Surveys, Studies, Statistics, & Petitions

(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

Blog Post Reference:

August 29, 2020, Email to the National Library of Medicine Re: Depositor-Supplied Synonyms in PubChem Documents; e.g., Grape Sugar

https://cornallergyadvocacyresources.blogspot.com/2020/08/august-29-2020-email-to-national.html

August 29, 2020, Email to the FDA and the NIH National Library of Medicine Re: Immediate Revision of PubChem Documents Equating Glucose (Blood Sugar) with Dextrose (Corn Sugar)

Numerous online publications erroneously claim that glucose (blood sugar) and dextrose (corn sugar) [1] are identical (or nearly identical), thereby endangering the lives of corn-allergic consumers and patients. [2-7]  The molecular weights of the following two compounds are not identical.  Therefore, which one of these molecular formulas represents straight blood sugar (glucose): the "main sugar that the body manufactures [and] serves as the major source of energy for living cells?” [8] It is clear that the definition of glucose (blood sugar) by Dr. William C. Shiel, Jr. supports the fact that glucose (blood sugar) cannot be equated with corn sugar manufactured from cornstarch (dextrose), since our body does not manufacture corn sugar (dextrose).

Re: PubChem CID 79025, alpha-D-Glucose

The Molecular Formula, C6H12O6, is a corn sugar (dextrose) formulation; and has a Molecular Weight of 180.16 g/mol.

https://pubchem.ncbi.nlm.nih.gov/compound/79025

Re: PubChem CID 66370, Dextrose

The Molecular Formula, C6H14O7, is also a corn sugar (dextrose) formulation; and has a Molecular Weight of 198.17 g/mol.

https://pubchem.ncbi.nlm.nih.gov/compound/Dextrose

Why is this Determination Critical?

In our corn allergy support groups of over 12K members, personal testimonies reveal that the majority of medical professionals are not aware that dextrose is corn sugar manufactured from cornstarch which can prove fatal to anyone with an IgE-mediated allergy to corn.  It is for this reason that intravenous fluids to which corn sugar (dextrose) has been added are contraindicated for administration to corn-allergic patients. [9] These medical professionals are erroneously equating glucose (blood sugar) with dextrose (corn sugar), thereby endangering the lives of corn-allergic patients.

One physician actually told a corn-allergic patient that “No one can be allergic to dextrose,” and proceeded to administer corn sugar (dextrose) IV fluid to this patient in direct violation of the contraindication warning in the package insert, which resulted in a severe allergic reaction requiring emergency intervention.  As a result of this testimony, and many other similar reports by our members, it took me three years to forward corn allergy documentation to the majority of our nation’s hospitals, colleges of medicine, and colleges of pharmacy.

Even after this monumental effort for the safety of corn-allergic patients, it is apparent that the majority of medical professionals remain oblivious to the danger of corn sugar (dextrose) for patients with an IgE-mediated allergy to corn.  Only recently, it was reported that a physician told a corn-allergic patient that “No one can be allergic to dextrose, since dextrose is naturally present in our bodies.”  He then administered the dextrose-containing IV fluid to this patient resulting in an anaphylactic reaction requiring emergency intervention.

Conclusion:

The contention that glucose (blood sugar) and dextrose (corn sugar) are “identical” is a false narrative which appears to have been initiated by the corn industry decades ago; [10] and endangers the lives of corn-allergic patients and consumers; e.g., some food manufacturers claim their products are corn free even though the product contains dextrose (corn sugar).

Immediate Revision is Required:

This false narrative may never have been revealed without Facebook, which provides a platform for addressing specific and non-specific IgE-mediated allergies through allergy support groups; e.g., these allergy support groups have revealed that, based on membership, corn allergies are more than twice as prevalent as sesame seed allergies. 

Now that this false narrative has been exposed, we are demanding that the NIH National Library of Medicine issue an immediate revision clarifying that these two distinct forms of sugar (one natural; one manufactured from cornstarch) are not identical. [11]

This critical correction will undoubtedly result in the required revision of many published papers; however, protecting the lives of corn-allergic consumers and patients should be your top priority.

Thank you for your immediate attention to this critical concern. 

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References:

[1] CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

[2] "D-glucose is often referred to as Dextrose or Dextro, they are one and the same and are biochemically identical to the glucose are bodies need."

https://www.liftglucose.com/what-is-the-difference-between-glucose-dextrose/#:~:text=D%2Dglucose%20is%20often%20referred,the%20glucose%20are%20bodies%20need.

[3] "Glucose is the sugar in blood, and dextrose is the name given to glucose produced from corn. Biochemically they are identical."

https://www.goodhousekeeping.com/food-recipes/healthy/a18910/types-of-sugar-0921/

[4] "Glucose and dextrose are almost the same (emphasis added). But these terms are different when considering their chemical structures; glucose molecules can be found in both D-glucose form and L-glucose form but, the term dextrose is used only for D-glucose molecules. Thus, the main difference between glucose and dextrose is that glucose includes both D-form and L-form whereas dextrose includes only the D-form of glucose.” (emphasis added)

https://pediaa.com/difference-between-glucose-and-dextrose/

[5] "Overall, although both has the same chemical formula (emphasis added) and are simple monosaccharides (sugars) glucose and dextrose still differ . . .” (emphasis added)

http://www.differencebetween.net/science/difference-between-glucose-and-dextrose/

[6] "Glucose and Dextrose are biochemically identical."

https://ingredi.com/blog/whats-the-difference-between-dextrose-and-table-sugar/

[7] "Dextrose (chemically identical to glucose) . . ."

https://opentextbc.ca/ingredients/chapter/glucosedextrose/

[8] William C. Shiel, Jr., MD, FACP, FACR, Medical Definition of Glucose, MedicineNet

https://www.medicinenet.com/script/main/art.asp?articlekey=3608

[9] CORN SUGAR (DEXTROSE) IV FLUIDS CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

[10] “Dextrose: All-American Corn Sugar,” Candy Professor, September 29, 2010

https://candyprofessor.com/2010/09/29/dextrose-all-american-corn-sugar/#:~:text=But%20by%201866%2C%20someone%20figured,dextrose%20from%20that%20corn%20starch

[11] Dextrose: Facts vs. Fiction

https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

Additional References

My August 29, 2020, Email to the National Library of Medicine Re: Depositor-Supplied Synonyms in PubChem Documents; e.g., Grape Sugar

https://cornallergyadvocacyresources.blogspot.com/2020/08/august-29-2020-email-to-national.html

My July 2, 2020, Appeal to the NIH National Library of Medicine Re: PubChem CID 79025, Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Derived from Cornstarch)

https://cornallergyadvocacyresources.blogspot.com/2020/07/my-july-2-2020-appeal-to-nih-national.html

Corn Allergy: A Potentially Life-Threatening Diagnosis

https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

July, 2020, Month-End Corn Allergy Statistics: 949.9% Increase in 85 Months

(Corn is ubiquitous and is EXEMPT from FDA labeling requirements, resulting in underreporting and suppression of corn allergy statistics).

https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Corn Allergy References, Surveys, Studies, Statistics, & Petitions

(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

Blog Post Reference:

August 29, 2020, Email to the FDA and the NIH National Library of Medicine Re: Immediate Revision of PubChem Documents Equating Glucose (Blood Sugar) with Dextrose (Corn Sugar)

https://cornallergyadvocacyresources.blogspot.com/2020/08/august-29-2020-email-to-fda-and-nih.html

My August 26, 2020, Email to the FDA and the NIH National Library of Medicine Re: Molecular Formula for Glucose (Blood Sugar) vs. Dextrose (Corn Sugar)

Re: Case CAS-592684-L3B4Z2 - National Library of Medicine Customer Service confirmation TRACKING:000435000512147

Since I discovered that the National Library of Medicine references articles from Wikipedia, this has raised additional questions for factual information regarding pure blood sugar (glucose) vs. dextrose (corn sugar)

I may have discovered a possible false narrative, and I would like to know in what year dextrose (corn sugar manufactured from cornstarch) was first synthesized to be biochemically identical to pure blood sugar (glucose)?  Many publications (including my own blog) quote the same narrative that dextrose (corn sugar) and glucose (blood sugar) are biochemically identical (Molecular Formula C6H12O6).  However, it appears that this may not be factual.

Can you explain why dextrose (corn sugar) has a molecular formula of C6H1407?  This is not the same molecular formula of blood sugar, unless the molecular formula of pure blood sugar (glucose) is also C6H1407.

Dextrose PubChem 66370, Dextrose, Molecular Formula C6H14O7

https://pubchem.ncbi.nlm.nih.gov/compound/66370

Dextrose is corn sugar pursuant to Code of Federal Regulation 21CFR184.1857

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

This refers to corn sugar (dextrose), so you are stating that dextrose (corn sugar) is biochemically identical to dextrose (corn sugar)..
alpha-D-Glucose PubChem 79025, Molecular Formula C6H12O6
https://pubchem.ncbi.nlm.nih.gov/compound/79025

This is not "pure" blood sugar (glucose), but refers to dextrose (corn sugar). so you are stating that dextrose (corn sugar) is biochemically identical to dextrose (corn sugar)..

D-Glucose (Compound) PubChem 5793, Molecular Formula C6H12O6

https://pubchem.ncbi.nlm.nih.gov/compound/5793

Production of dextrose from starch
https://patents.google.com/patent/US3039936A/en

Question:

What is the actual molecular formula of pure blood sugar (glucose), which is not to be confused with dextrose (corn sugar); e.g., nothing that is designated with the letter "D" (which represents corn sugar, dextrose)? 

Thank you for your assistance.

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

References:

My July 2, 2020, Appeal to the NIH National Library of Medicine Re: PubChem CID 79025, Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Derived from Cornstarch)

https://cornallergyadvocacyresources.blogspot.com/2020/07/my-july-2-2020-appeal-to-nih-national.html

Dextrose: Facts vs. Fiction

https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

Blog Post Link:

My August 26, 2020, Email to the FDA and the NIH National Library of Medicine Re: Molecular Formula for Glucose (Blood Sugar) vs. Dextrose (Corn Sugar)

https://cornallergyadvocacyresources.blogspot.com/2020/08/my-august-26-2020-email-to-fda-and-nih.html

My August 25, 2020, Emails to the NIH National Library of Medicine Re: Ascorbic Acid vs. Vitamin C

CRITICAL UPDATE:  Since submitting my email to the NIH National Library of Medicine this afternoon, the FDA just changed their classification of ascorbic acid from "Chemical Preservatives" to "Nutrients."  They revised it 8/25/2020, but did not indicate the date of revision.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.8013

They changed the URL reference for Subpart D to Subpart I.  This is the current link to Subpart D, which classifies ascorbic acid as “Chemical Preservatives.”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.3013

Reference added 4:10 pm EST, August 25, 2020:

"Ascorbic acid is also an industrially produced commodity, with preparations from D-glucose [DEXTROSE (CORN SUGAR)] . . ." Due to the availability of synthetic sources of ascorbic acid, it has become the primary source of the substance for food handling and processing applications." (emphasis added)
https://www.ams.usda.gov/sites/default/files/media/AscorbicAcidTRFinal7172019.pdf

---------------------------------------------------------------------

Second Email submitted as 4:55 pm EST, August 25, 2020, CAS-592356-L5Z5D1

To:  NIH National Library of Medicine, pubmedcentral@ncbi.nlm.nih.gov, Case #CAS-592247-DOS4H6

Re: Correction to Publication

Corrections are required in an article: Covarrubias-Pinto A, Acuña AI, Beltrán FA, Torres-Díaz L, Castro MA. Old Things New View: Ascorbic Acid Protects the Brain in Neurodegenerative Disorders. Int J Mol Sci. 2015 Nov 27;16(12):28194-217. doi: 10.3390/ijms161226095. PMID: 26633354; PMCID: PMC4691042
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4691042/

The United States Department of Agriculture classifies ascorbic acid as follows:

“Ascorbic acid is also an industrially produced commodity, with preparations from D-glucose [DEXTROSE (CORN SUGAR)] . . ." Due to the availability of synthetic sources of ascorbic acid, it has become the primary source (emphasis added) of the substance for food handling and processing applications.

https://www.ams.usda.gov/sites/default/files/media/AscorbicAcidTRFinal7172019.pdf

The FDA classifies Corn Sugar as Dextrose (D-glucose), Code of Federal Regulation 21CFR184.1857

“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 . . .”

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Throughout this article, the term "ascorbic acid" needs to be replaced with "Vitamin C."

Examples of the misuse of the term "ascorbic acid" in this article.

1.  "Ascorbic acid . . . is an essential metabolite for a variety of organisms."
Rebuttal:  Corn sugar (dextrose) is not "an essential metabolite for a variety of organisms."

2.  "It is present in multiple fruits and vegetables."
Rebuttal:  It is impossible for corn sugar (dextrose) to be found naturally in any food products.

3.  ". . . is also synthesized from glucose in the liver . . ."
Rebuttal:  Corn sugar (dextrose) is not synthesized from glucose in the liver.

4. "Ascorbic acid is an important antioxidant with multiple cellular functions."
Rebuttal:  Corn sugar (dextrose) is not an antioxidant.

5. "Ascorbic acid is concentrated in the brain."
Rebuttal:  Corn sugar (dextrose) is not found in the brain of any living organism.


In summary, this article, as written, can endanger the lives of individuals with an IgE-mediated allergy to corn; since ascorbic acid primarily sourced from corn sugar (dextrose) is being equated with naturally-occurring Vitamin C.

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

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

---------------------------------------------------------------

First Email Submitted August 25, 2020 Case #CAS-592247-DOS4H6

To:  NIH National Library of Medicine, pubmedcentral@ncbi.nlm.nih.gov, Case #CAS-592247-DOS4H6

Re: Correction to Publication

Corrections are required in an article: Covarrubias-Pinto A, Acuña AI, Beltrán FA, Torres-Díaz L, Castro MA. Old Things New View: Ascorbic Acid Protects the Brain in Neurodegenerative Disorders. Int J Mol Sci. 2015 Nov 27;16(12):28194-217. doi: 10.3390/ijms161226095. PMID: 26633354; PMCID: PMC4691042
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4691042/

Pursuant to Code of Federal Regulation 21CFR182.3013, Subpart D, ascorbic acid is clearly defined as a "chemical preservative." Ascorbic acid may be considered a synthetic version of Vitamin C; but it is not Vitamin C.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.8013

Throughout this article, the term "ascorbic acid" needs to be replaced with "Vitamin C."

Examples of the misuse of the term "ascorbic acid" in this article.

1.  "Ascorbic acid . . . is an essential metabolite for a variety of organisms."
Rebuttal:  This chemical preservative is not "an essential metabolite for a variety of organisms."

2.  "It is present in multiple fruits and vegetables."
Rebuttal:  It is impossible for this chemical preservative to be found naturally in any food products.

3.  ". . . is also synthesized from glucose in the liver . . ."
Rebuttal:  This chemical preservative is not synthesized from glucose in the liver.

4. "Ascorbic acid is an important antioxidant with multiple cellular functions."
Rebuttal:  This chemical preservative is not an antioxidant.

5. "Ascorbic acid is concentrated in the brain."
Rebuttal:  This chemical preservative is not found in the brain of any living organism.

Personal certification:  I am not allergic to Vitamin C, but am highly allergic to ascorbic acid that is used as a chemical preservative in many food products such as fruit juices.  This is due to the fact that most ascorbic acid is derived from corn, and I have an IgE-mediated allergy to corn.

In summary, this article, as written, can endanger the lives of individuals with an IgE-mediated allergy to corn; since ascorbic acid (a chemical preservative usually derived from corn) is being equated with naturally-occurring Vitamin C.


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

Blog post link:

My August 25, 2020, Emails to the NIH National Library of Medicine Re: Ascorbic Acid vs. Vitamin C

https://cornallergyadvocacyresources.blogspot.com/2020/08/my-august-25-2020-emails-to-nih.html

My July 2, 2020, Appeal to the NIH National Library of Medicine Re: PubChem CID 79025, Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Derived from Cornstarch)

(Updated July 26, 2020)

             Based on testimonies from the 12K+ members of our corn allergy support groups, it is apparent that the vast majority of medical professionals are unaware that dextrose is the sugar derived from cornstarch per Code of Federal Regulation 21CFR184.1857; [1] and is, therefore, contraindicated for corn-allergic consumers/patients. [2]  However, these contraindication warnings remain inconsistent. [3]  It was also reported in one of our corn allergy support groups that a physician told  a corn-allergic patient that “No one can be allergic to dextrose;” and he proceeded to administer dextrose IV fluid to this patient in direct violation of the contraindication warning on the package insert, which resulted in a severe allergic reaction requiring emergency intervention.  As a result of this incident, it took me three years to forward corn allergy documentation to the majority of our nation’s hospitals, colleges of medicine, and colleges of pharmacy. [4-6] 

           

Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Manufactured from Cornstarch)

            While conducting research on this topic, it became clear that many reference sources also lack adequate understanding of the critical difference between these two sugars (one natural; the other manufactured); e.g., Wikipedia erroneously redirects the reader to “Glucose” if “Dextrose” is searched on their website. [7]  I made a disturbing discovery today when I referenced the National Institutes of Health (NIH), National Library of Medicine’s website; which may also explain (but not excuse) the lack of knowledge by medical professionals about the source of dextrose, thereby endangering the lives of corn-allergic consumers/patients. [8]           

            Glucose (blood sugar) and dextrose (corn sugar manufactured from cornstarch) may be biochemically identical (Molecular Formula: C₆H₁₂O₆); however, not with regard to their allergenicity; e.g., glucose (blood sugar) cannot provoke an allergic response, whereas dextrose (corn sugar derived from cornstarch) can prove fatal to anyone with an IgE-mediated allergy to corn. [9,10] 

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CRITICAL UPDATE

WE ARE CHALLENGING THE MOLECULAR FORMULA
THAT THE FDA HAS ASSIGNED TO CORN SUGAR IN 21CFR184.1857

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

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            Dextrose is corn sugar that is ADDED TO food/drug/biologic products.  It is NOT naturally occurring, and cannot be found in fruits or other plants; because it is a manufactured sugar from cornstarch.  Therefore, the following statement on the NIH National Library of Medicine’s website is not entirely correct:  "Alpha-D-Glucose is 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."

             Glucose (blood sugar) is the “primary source of energy for living organisms” - NOT CORN SUGAR!  Since dextrose is a manufactured sugar from cornstarch; it is impossible for corn sugar to be found "naturally" in fruits or anywhere else for that matter, unless it is ADDED TO a food/drug/biologic product.

            The NIH National Library of Medicine is erroneously equating glucose (blood sugar) with dextrose (corn sugar manufactured from cornstarch), which is why I believe that the majority of medical professionals remain oblivious to the danger of dextrose (corn sugar) for corn-allergic consumers/patients.

My July 2, 2020, Appeal to the NIH National Library of Medicine

            Based on the factual evidence I provided to the NIH National Library of Medicine regarding the difference between glucose and dextrose, it is my hope that they will revise their description of these two distinct forms of sugar to reflect these critical facts for the safety of corn-allergic consumers/patients. 

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References

[1] CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

[2] LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

[3] PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://www.change.org/p/u-s-department-of-health-and-human-services-medical-biologic-products-with-dextrose-must-be-contraindicated-for-corn-allergic-patients

[4] United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients

https://cornallergyadvocacyresources.blogspot.com/2017/07/united-states-hospitalshealth-systems.html

[5] Colleges of Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients

https://cornallergyadvocacyresources.blogspot.com/2018/04/colleges-of-medicine-contacted-re.html

[6] Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients

https://cornallergyadvocacyresources.blogspot.com/2018/05/colleges-of-pharmacy-contacted-re.html

[7] “Glucose” (Redirected from Dextrose)

https://en.wikipedia.org/wiki/Glucose

[8] National Center for Biotechnology Information. PubChem Database. alpha-D-Glucose, CID=79025, https://pubchem.ncbi.nlm.nih.gov/compound/alpha-D-Glucose (accessed on July 3, 2020)

https://pubchem.ncbi.nlm.nih.gov/compound/alpha-D-Glucose

[9] Guharoy SR, Barajas M. Probable anaphylactic reaction to corn-derived dextrose solution. Vet Hum Toxicol. 1991;33(6):609-610.

https://pubmed.ncbi.nlm.nih.gov/1808842/

[10] College of Pharmacists of British Columbia, Warning: corn-related allergens,

Non-medicinal ingredients don’t appear on drug labels, ReadLinks, May/June 2007, Vol. 32, No. 3

http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

Additional References

Corn Allergy: A Potentially Life-Threatening Diagnosis

https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

June, 2020, Month-End Corn Allergy Statistics: 943.8% Increase in 84 Months

(Corn is ubiquitous & EXEMPT from FDA labeling requirements, resulting in underreporting & suppression of corn allergy statistics).

https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Corn Allergy References, Surveys, Studies, Statistics, & Petitions

(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

Reference Added July 24, 2020

The corn industry has been controlling the false narrative re: corn sugar derived from cornstarch (dextrose) by declaring dextrose "Nature's own body sugar" since 1941!  The United States government continues to propagate this false narrative, thereby endangering the lives of corn-allergic patients/consumers.  Again, dextrose (corn sugar manufactured from cornstarch) is NOT present in fruit!

https://candyprofessor.com/2010/09/29/dextrose-all-american-corn-sugar/#:~:text=But%20by%201866%2C%20someone%20figured,dextrose%20from%20that%20corn%20starch

My July 26, 2020, Email to the NIH National Library of Medicine:

NLM Communications Team:

"For your edification:

The FDA confirms that dextrose is a food [or drug/biologic] additive.

If dextrose was “natural,” it would not be included on the FDA’s Food Additive Status List as Generally Recognized as Safe (GRAS), 184.1857.  It is a manufactured ingredient.

https://www.fda.gov/food/food-additives-petitions/food-additive-status-list#ftnD

Since glucose (blood sugar) is natural, glucose is NOT included on the FDA's Food Additive Status List.  

Furthermore, your statement ". . . reflects the chemical community’s accepted definition and terms, . . ." is not an acceptable argument for using these terms interchangeably."

Cordially,

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

My June 24, 2020, Email to the FDA and CDC Addressing Contraindication Warnings for Drug/Biologic Products Based on the Source of Excipients

To:      FDA, druginfo@fda.hhs.gov

           CDC, NIPINFO@cdc.gov 

            Due to potential liability, I would encourage physicians to petition the FDA to mandate that contraindication warnings be clearly listed in the package insert for all drug/biologic products based on the "source of all excipients;" since it is their responsibility to verify the source of excipients prior to prescribing drug/biologic products to their patients with confirmed IgE-mediated allergies.  

            Therefore, I have forwarded the following documentation to the majority of pharmaceutical companies, physician associations, and leading healthcare organizations in an effort to protect physicians from potential liability, in addition to protecting their patients from allergic reactions to drug/biologic products. I will also be forwarding this documentation to the leading medical journals.

Physicians may be liable if they prescribe drugs/biologics containing excipients derived from a patient's allergens, even if no contraindication warning is present in the package insert. They are required to confirm the source of all excipients.

https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-2-2020-email-to-world-allergy.html

My June 16, 2020, Email to the FDA Re: Corn Labeling in Drug/Biologic Products

https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-16-2020-email-to-fda-re-corn.html

Corn is ubiquitous and is EXEMPT from FDA labeling requirements; therefore, allergic reactions are currently categorized as idiopathic, resulting in underreporting and suppression of corn allergy statistics.

https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

            Physicians continue to ignore the contraindication warning on the package insert accompanying IV fluids to which dextrose (corn sugar derived from cornstarch) has been added, even though it took me three years to forward the package insert to our nation's hospitals, colleges of medicine, and colleges of pharmacy.  In addition, we continue to receive reports from the 12K+ members in our corn allergy support groups that physicians continue to prescribe drug/biologic products to their corn-allergic patients, even though these products contain excipients derived from corn.  Therefore, I have added a sixth option for reporting these events.

    "6.  Consult with legal counsel, since medical professionals are required to verify the "source" of ALL excipients in drug/biologic products BEFORE prescribing to their patients, even if no contraindication warning is present on the drug label."

Revised June 24, 2020

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

Added References:

ALLERGIC TO YOUR MEDICATION: WHAT YOUR DOCTOR SHOULD KNOW

“Doctors should have your medical history, including all known allergies, on file. OF course, many patients aren’t aware of the full extent of their drug allergies, so it is important that a doctor discloses to their patient what the drug is they’re prescribing and whether it has known side-effects or might cause an allergic reaction.”

https://novak-law.com/allergic-to-your-medication-what-your-doctor-should-know/

"Inactive" ingredients in oral medications

https://stm.sciencemag.org/content/11/483/eaau6753

93 percent of medications contain 'potential allergens'

https://www.medicalnewstoday.com/articles/324681

            Thank you for your attention to this growing concern, and it is my hope that physicians file an immediate petition with the FDA to mandate these critical contraindication warnings based on the source of excipients. 

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

  

Revised June 23, 2020

Pharmaceutical Companies Contacted Re: Protocol for Treating Corn-Allergic Patients

https://cornallergyadvocacyresources.blogspot.com/2017/05/pharmaceutical-companies-contacted.html

Additional References:

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://www.change.org/p/u-s-department-of-health-and-human-services-medical-biologic-products-with-dextrose-must-be-contraindicated-for-corn-allergic-patients

Corn Allergy References, Surveys, Studies, Statistics, & Petitions

(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html