The FDA's Endangerment of Corn-Allergic Individuals (Documented)

This discovery began with the American College of Allergy, Asthma & Immunology (ACAAI) in 2018, when they made the following false claim on their website. [They have suspended this page at our request.]

“Most corn-derived products, like cornstarch and high-fructose corn syrup, do not contain corn protein. If you have a corn allergy, you do not need to avoid these products.”
https://acaai.org/allergies/types/food-allergies/types-food-allergy/corn-allergy

Timeline:

March 15, 2018

Based on this claim by the ACAAI, I conducted an oral challenge of Argo cornstarch; and suffered a severe allergic reaction due to my IgE-mediated allergy to corn.  I immediately called the ACAAI with the results of my oral challenge, and appealed to them to remove this false statement from their website. 

Argo Cornstarch Oral Challenge to Test Hypothesis Presented by the ACAAI
https://cornallergyadvocacyresources.blogspot.com/2018/03/argo-cornstarch-oral-challenge-to-test.html

March 27, 2018

Since the ACAAI made no attempt to correct this statement, I mailed them a certified letter of appeal.  In addition, I also filed a petition against them; since they were clearly denying the allergenicity of cornstarch.   

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

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

Early 2019:

Approximately one year after receipt of my certified letter, the ACAAI redacted their claim regarding cornstarch; however, I continued to appeal to them to redact their equally false claim regarding corn syrup. 

October 18, 2020

I submitted the following inquiry to the Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN)

“The ACAAI specifically declares: "Most corn-derived products, like high-fructose corn syrup, do not contain corn protein." [They recently suspended this page at our request.]
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 corn syrup contains no allergenic corn protein. Thank you.” 

October 19, 2020

I received the following reply from the Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN), 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.”

October 20, 2020

I sent an email to the ACAAI with the FDA’s directive.

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

February 18, 2021

My February 18, 2021, email exchange with Rick Slawny, Executive Director for the American College of Allergy, Asthma & Immunology (ACAAI), is documented in the following blog post:
https://cornallergyadvocacyresources.blogspot.com/2021/03/the-acaais-endangerment-of-corn.html

February 20, 2021

The ACAAI suspended their page addressing corn allergies from their website; however, I continued to appeal to them to suspend their "Infant Formulas and Corn Allergy" page, since it clearly endangered the lives of corn-allergic infants.
https://acaai.org/allergies/types/food-allergies/types-food-allergy/corn-allergy

Important Note:  It appears that the ACAAI is erroneously equating “impurities” with “allergenic corn protein.”  Would they apply this same theory to foods listed in the “Top 8” allergens, or are they just targeting corn?

[They have suspended this page at our request.]
“The corn component in the hypoallergenic formulae is corn syrup, derived from corn starch [sic] which has been processed to remove any impurities. This corn starch [sic] does not have any corn protein in it.” [emphasis added]
https://acaai.org/resources/connect/ask-allergist/infant-formulas-and-corn-allergy

FALCPA establishes a process under 21 U.S.C. 343(w)(7) by which any person may file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.” The scientific evidence must include the analytical method used and the ingredient must be derived by the specified method. FDA has 90 days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA's labeling requirements for major food allergens.
https://www.fda.gov/food/food-labeling-nutrition/inventory-notifications-received-under-21-usc-343w7-exemptions-food-allergen-labeling

February 21, 2021

In response to the directive from the FDA to "contact the ACAAI for information about the testing procedures used to justify their claims," Rick Slawny used the following document published by the FDA as justification; since the ACAAI interpreted the FDA's "100% glucose" (blood sugar naturally present in all living organisms) claim as having no corn allergenic protein.  HFCS is manufactured from allergenic cornstarch; so HFCS does, in fact, contain allergenic corn protein  – “pure” or “impure.” 

"High Fructose Corn Syrup Questions and Answers,” FDA

"Where does HFCS come from?

HFCS is derived from corn starch [sic]. [emphasis added]

When corn starch [sic] is broken down into individual glucose molecules, the end product is corn syrup, which is essentially 100% glucose." [emphasis added]  

The correct term is “100% D-glucose.”
https://www.fda.gov/food/food-additives-petitions/high-fructose-corn-syrup-questions-and-answers

March 24, 2021:

I emailed my following blog post to Rick Slawny:

The ACAAI's Endangerment of Corn-Allergic Infants (Documented)
https://cornallergyadvocacyresources.blogspot.com/2021/03/the-acaais-endangerment-of-corn.html

March 26, 2021:

For the safety of corn-allergic infants, we are grateful that the ACAAI also suspended this page from their website.
https://acaai.org/resources/connect/ask-allergist/infant-formulas-and-corn-allergy

 

Additional Documentation Confirming the FDA is Endangering Corn-Allergic Individuals

Again, let me reiterate that the FDA is fully aware that dextrose is corn sugar/D-glucose.

Pursuant to Code of Federal Regulation 21CFR184.1857:

Dextrose = corn sugar manufactured from cornstarch = D-glucose
Dextrose = D-glucose = corn sugar manufactured from cornstarch
Corn sugar manufactured from cornstarch = dextrose = D-glucose
Corn sugar manufactured from cornstarch = D-glucose = dextrose
D-glucose = dextrose = corn sugar manufactured from cornstarch
D-glucose = corn sugar manufactured from cornstarch = dextrose
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Since dextrose (D-glucose) is corn sugar manufactured from cornstarch, it is an ADDED sugar that is never naturally present in any other food products or in the human body.  Glucose (blood sugar) is naturally present in all living organisms – NOT corn sugar!  Glucose (blood sugar) is produced by the liver – NOT corn sugar!  Dextrose (corn sugar) is a glucose (blood sugar)-elevating agent.

"The Liver & Blood Sugar," University of California, San Francisco
https://dtc.ucsf.edu/types-of-diabetes/type1/understanding-type-1-diabetes/how-the-body-processes-sugar/the-liver-blood-sugar/

"What is Glucose?," WebMD
https://www.webmd.com/diabetes/glucose-diabetes

Dextrose (corn sugar/D-glucose) is a glucose (blood sugar)-elevating agent.
https://reference.medscape.com/drug/d50w-dglucose-dextrose-342705

Dextrose Equivalent (DE) is only derived from corn.
https://www.austradeinc.com/products/sweeteners/

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn. Dextrin (usually derived from corn) may be derived from food products other than corn.
https://cornallergyadvocacyresources.blogspot.com/2020/12/confirmation-that-dextrose-corn-sugard.html

Companies I reported to the FDA’s Center for Food Safety and Applied Nutrition (Mislabeled Food Product):

There is no such thing as tapioca-derived dextrose, wheat-derived dextrose, rice-derived dextrose, etc.  Dextrose is corn sugar manufactured from cornstarch/D-glucose; therefore, it is impossible to derive corn sugar from any food product other than corn.

The following companies are falsely implying that dextrose (corn sugar) is derived from a food product other than corn; e.g., tapioca.  The FDA’s reply to my complaint was to submit these mislabeled food products to my state FDA consumer complaint coordinator, since they lacked adequate staffing to address corn allergy claims.  After supplying my state consumer complaint coordinator with indisputable documentation that these products were 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, in the form of dextrose equivalent (DE), was added.  The FDA has done nothing to address this critical issue. 

TapiOK® Tapioca Dextrose, Organic, Ciranda
https://www.ulprospector.com/en/na/Food/Detail/6025/206054/TapiOK-Tapioca-Dextrose--Organic

Certified Organic Tapioca Dextrose, Parchem
[Documentation forwarded to them via email, 12/15/2020.]
https://www.parchem.com/chemical-supplier-distributor/Certified-Organic-Tapioca-Dextrose-006117.aspx

Tapioca Dextrose, Mike’s Mix
[Note that they are also falsely claiming this product is corn free, which endangers the lives of corn-allergic consumers. I have exchanged over 40 emails with this company since September, 2020, and they refuse to redact their corn-free/tapioca dextrose claims.]
https://mikesmixture.com/products/tapioca-dextrose?_pos=1&_sid=2b7cb53cb&_ss=r

Tapioca Starch Dextrose, Alibaba.com
[Removed from their website after I provided them with the requisite documentation.]
https://www.alibaba.com/product-detail/tapioca-starch-dextrose-fufeng-dextrose_62108273451.html?spm=a2700.7724857.normal_offer.d_image.3a3d1eb9747CbL

Tapioca Starch Dextrose Monohydrate, Alibaba.com
[Removed from their website after I provided them with the requisite documentation.]
https://www.alibaba.com/product-detail/tapioca-starch-dextrose-monohydrate-bulk-glucose_62108429284.html?spm=a2700.7724857.normal_offer.d_image.3a3d1eb9747CbL

Tapioca Dextrose, A. G. Commodities, Inc.
[Sent email 12/27/20, and they removed this reference from their website.]
http://www.tapiocadextrose.com/

Tapioca Dextrose, Protein Muffins, Trader Joe’s
[I was unable to notify this company of this mislabeled food product.]
https://www.traderjoes.com/home/products/pdp/068421

Organic Tapioca Dextrose, Nature’s Flavors
[Sent email 12/30/20.]
https://www.naturesflavors.com/organic-ingredients/63825-organic-dextrose-powder-kosher-vegan-gluten-free.html?search_query=tapioca+dextrose&results=4

Tapioca Dextrose Monohydrate, Essex Food Ingredients
[Sent documentation to them on 12/2/2020 via online contact form.]
https://essexfoodingredients.com/product/tapioca-dextrose-monohydrate/

Dextrose (Tapioca Derived)
[Sent documentation to them on 11/25/2020 via email.]
http://www.ffi-corp.com/products.asp

 
Why is this important?

These mislabeled food products not only endanger the lives of corn-allergic consumers, but they also place the manufacturer/retailer at risk for liability.  Corn may be exempt from FDA labeling requirements; however, no manufacturer/retailer can “imply” their product is free from corn, or make a “corn-free” claim, when the product actually contains corn-derived ingredients.

 

SUMMARY:

It is incomprehensible that the ACAAI, a "professional medical organization of more than 6,000 allergists-immunologists and allied health professionals" would not know that cornstarch (which includes anything manufactured from cornstarch) can prove deadly to anyone with an IgE-mediated allergy to corn; since cornstarch contains allergenic corn protein.  We are grateful that the ACAAI has finally suspended both of the referenced pages from their website for the safety of corn-allergic consumers. 
https://acaai.org/about-college

The FDA is fully aware of the critical difference between glucose (blood sugar) vs. D-glucose (corn sugar/dextrose).   If this was just a typographical error, we are requesting that the FDA immediately correct this document from "100% glucose" to "100% D-glucose."  If this was intentional, then we are demanding that the FDA provide "information about the testing procedures used to justify their claims" in equating HFCS with glucose (blood sugar).
https://www.fda.gov/food/food-additives-petitions/high-fructose-corn-syrup-questions-and-answers

The FDA must also correct their errors in 21CFR182.1866.

"High fructose corn syrup. 

    (a) Product. High fructose corn syrup is a sweet, nutritive saccharide mixture containing approximately 52 percent (dry weight) glucose [correct to read:  D-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 [sic] hydrolysate by partial enzymatic conversion of glucose (dextrose) . . ." [correct to read: D-glucose (dextrose)]
https://www.govinfo.gov/content/pkg/CFR-1996-title21-vol3/html/CFR-1996-title21-vol3-sec182-1866.htm

The FDA must immediately cease endangering the lives of individuals with an IgE-mediated allergy to corn!

 

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

 

Additional Documentation/References:

If “dextrose” is referenced on the FDA's Food Additive Status List, it refers to 21CFR184.1857.
https://www.fda.gov/food/food-additives-petitions/food-additive-status-list#ftnD

21CFR184.1857 defines corn sugar manufactured from cornstarch as dextrose/D-glucose
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

"FDA Rules Corn Syrup Can't Change Its Name To Corn Sugar"

"Also, there's already something else on the market called corn sugar. It's the name for the sweetener dextrose, and has been used by people who have trouble tolerating regular sugar for 30 years, the FDA says."
https://www.npr.org/sections/thesalt/2012/05/30/154009682/fda-rules-corn-syrup-cant-change-its-name-to-corn-sugar

The Corn Refiners Association correctly identifies corn-derived sweeteners with the requisite “D-“ modifier (DE for dextrose equivalent).  This critical modifier has been omitted from many published articles over many decades, which is the reason that corn-derived sweeteners are being erroneously equated with blood sugar (glucose); thus, endangering the lives of corn-allergic consumers and patients.

Nutritive Sweeteners From Corn, Corn Refiners Association, 2006
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf

The USDA and National Agricultural Library are complicit in the deception of equating blood sugar (glucose) with corn sugar (dextrose/D-glucose). Pg. 294, "They are composed of various proportions of glucose (dextrose)..." [emphasis added]

The correct term is: D-glucose (dextrose). 
https://www.nal.usda.gov/sites/default/files/fnic_uploads/265-338.pdf

The false narrative for equating corn sugar (dextrose/D-glucose) with glucose (blood sugar) was initiated by the corn industry decades ago.  The propaganda is quite remarkable.

“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

"Conversion of Corn to Dextrose"

“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/

The America Heart Association defines HFCS as an ADDED sugar chemically manufactured [from ALLERGENIC CORNSTARCH]; therefore, it cannot be equated with "100% glucose" (blood sugar).
https://www.heart.org/en/healthy-living/healthy-eating/eat-smart/sugar/sugar-101

Administering dextrose-containing IV fluids to corn-allergic patients is a critical medical error equivalent to administering penicillin to patients with an allergy to penicillin.
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

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

Glucose (blood sugar) is produced by the liver; dextrose is corn sugar produced from cornstarch/D-glucose, 21CFR184.1857. Therefore, they cannot be "one and the same;" since our liver does NOT produce corn sugar (dextrose/D-glucose).
https://dtc.ucsf.edu/types-of-diabetes/type1/understanding-type-1-diabetes/how-the-body-processes-sugar/the-liver-blood-sugar/

Glucose (blood sugar) must NEVER be equated with dextrose (corn sugar manufactured from cornstarch).
[This petition does NOT solicit donations.]
PETITION: Defund the NIH National Library of Medicine for Willful Negligence
https://www.change.org/p/united-states-department-of-health-human-services-defund-the-nih-national-library-of-medicine-for-willful-negligence

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

The following recipients have responded positively to our message addressing the conflicting molecular formulas between the FDA and the NIH National Library of Medicine.

Allergy Strong, Washington, DC, @allergystrong

American Association of Surgical Physician Assistants (AASPA), @SurgeryPA

Arkansas Department of Human Services, Little Rock, AR, @ARHumanServices

Baptist Health, Northeast, FL, @BaptistHealthJx

Biology Online, @BiologyOnline2

Health New England, Springfield, MA, @HNEinc

Holy Redeemer Health, Meadowbrook, PA, @RedeemerHealth

Janice L. Pelletier, MD, FAAP, Orono/Penobscot, ME, @DrJanPeds

Ohio State University College of Medicine, Columbus, OH, @OhioStateMed

Primary Care Progress, Boston, MA, @PCareProgress

Society for Academic Emergency Medicine (SAEM), Des Plaines, IL, @SAEMonline [Retweeted]

St. Michael's Elite Hospital, Sugar Land, TX, @StMichaelsER

Stanford MedicineX, Stanford, CA, @StanfordMedX

University of Maryland Eastern Shore, Princess Anne, MD. @UMESNews

University of Pittsburgh School of Pharmacy, Pittsburgh, PA, @pittpharmacy

University of Saint Joseph, West Hartford, CT, @USJCT

Wolfson Children's Hospital, Jacksonville, FL, @WolfsonChildren

Drugs.com corrected their definition of dextrose!
PETITION: Demand that Drugs.com correct their definition of dextrose (corn sugar/D-glucose) for the safety of corn-allergic patients.

[This petition does NOT solicit donations.]
https://www.change.org/p/drugs-com-demand-that-drugs-com-correct-their-definition-of-dextrose-corn-sugar-d-glucose

The FDA should not be in the business of promoting corn-laden infant formulas.  Parents of corn-allergic infants are REQUIRED to make homemade infant formulas, since there are NO corn-free infant formulas available for these struggling babies.
https://www.fda.gov/consumers/consumer-updates/infant-formula-safety-dos-and-donts

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

 

Blog Post Reference:

The FDA's Endangerment of Corn-Allergic Individuals (Documented)
https://cornallergyadvocacyresources.blogspot.com/2021/04/the-fdas-endangerment-of-corn-allergic.html