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

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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To:  FDA Center for Drug Evaluation and Research (CDER), Email: druginfo@fda.hhs.gov

Re:  Corn Labeling in Drug/Biologic Products

Good afternoon:

Due to personal testimonies in our corn allergy support groups of over 12K members [more than double the membership in sesame seed allergy support groups] confirming that medical professionals continue to prescribe drugs containing corn to corn-allergic patients, even though the patient's allergy to corn is clearly documented in their medical record; it is our contention that corn is, in fact, EXEMPT from FDA labeling requirements in drug/biologic products.  This contention is also supported by medical professionals who are members of corn allergy support groups; e.g., many nurses, one retired physician, and a pharmacist.     

Therefore, we require this confirmation, IN WRITING, from the FDA to present to medical professionals (including pharmacists), many of whom are oblivious to the fact that the majority of drug/biologic products contain excipients derived from corn; which could, therefore, result in severe adverse reactions (including anaphylaxis) to corm-allergic patients. [See References]

In addition, which government agency has the authority to mandate that corn in drug/biologic products be labeled as containing corn; therefore, including a clear contraindication warning for administration to corn-allergic patients; e.g., Congress, the United States Department of Health and Human Services, the FDA, CDC, etc.?  [See References]

Which government agency has the authority to demand that the Children's Hospital of Philadelphia immediately redact their blatantly false and potentially life-threatening statement on their website addressing "Corn Allergies and Vaccines?" [See References]

Which government agency has the authority to demand that Drugs.com immediately correct their false and potentially life-threatening definition of "Dextrose" on their website?  Many medical professionals reference this website, which may be the reason that medical professionals continue to insist upon administering dextrose IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert?  Dextrose (corn sugar derived from cornstarch) and glucose (blood sugar) may be biochemically identical (Molecular Formula: C₆H₁₂O₆); however, not with regards to their allergenicity; e.g., glucose (blood sugar) cannot provoke an allergic response, but dextrose (corn sugar derived from cornstarch) can prove fatal to anaphylactic corn-allergic patients.  Therefore, glucose must not be equated with dextrose, as they are two separate entities. [See References]

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

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References:

Reprinted with permission from a pharmacist who is a member of a corn allergy support group:

"I’m a pharmacist who works in community practice. Earned my doctorate in 2007. We don’t learn hardly anything about the sources of inactive ingredients in school. I would never have known that so many meds have corn and corn derivatives in them unless my son had been diagnosed with FPIES in 2015. I would venture to say only a handful of other pharmacists nationwide are aware of this particular issue." - Pharmacist

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM

https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

BCPharmacists, "Warning: corn-related allergens . . ."

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

CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

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

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]
https://cornallergyadvocacyresources.blogspot.com/2020/01/vitamin-k1-injection-contains-corn.html

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), per FDA Federal Regulation 184.1857, vs. Glucose (Blood Sugar)
https://cornallergyadvocacyresources.blogspot.com/2020/03/email-to-fda-re-dextrose-corn-sugar-per.html

[Corn allergy documentation has also been forwarded to Dr. Offit, contributor to this article.]

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

My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines
https://cornallergyadvocacyresources.blogspot.com/2020/05/my-may-11-2020-email-to-fda-re-corn.html

My June 2, 2020, Email to the World Allergy Organization (WAO) Re:  Prescribing Drugs/Biologics for Patients with IgE-Mediated Allergies to Excipients

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

My June 5, 2020, Email to the FDA Re: Emergency Mandate Requiring Contraindication Warnings be Listed for Drug/Biologic Products Based on the "Source of Excipients"

https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-5-2020-email-to-fda-re.html

My June 8, 2020, Appeal to My State Congressional Representatives Requesting Contraindication Warnings for Drug/Biologic Products Based on the “Source of Excipients”

https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-8-2020-appeal-to-my-state.html

Additional References:

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

Corn Allergy: A Potentially Life-Threatening Diagnosis

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

Corn Allergy Statistics (Monthly)

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

Corn Products/Derivatives to Avoid with a Corn Allergy

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

[Imagine if this article was entitled: "Sesame Seed: It's Everything"]

Corn: It's Everything, Iowa Corn

https://www.iowacorn.org/education/corn-its-everything/