My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines

[DISCLAIMER]

Each person should consult with their physician concerning vaccinations.  

My only goal as a corn allergy advocate is to protect corn-allergic patients through the respectful education of medical and academic professionals as it relates to the complexities of navigating an allergy to corn.

______________________________________________

To:  FDA, Email: ocod@fda.hhs.gov

The FDA recently informed me, in writing, that corn is NOT exempt from FDA labeling requirements in food products -- only corn allergen warnings; however, based on food labels, it is apparent that the majority of manufacturers are in violation of this FDA mandate.

After reviewing the Vaccine Excipient Summary, it is apparent that corn is exempt from FDA labeling requirements in vaccines which could endanger the lives of corn-allergic patients; since the majority of vaccines contain corn-derived excipients.  Therefore, just as IV fluids containing dextrose (corn sugar derived from cornstarch) are contraindicated for corn-allergic patients, vaccines should also be contraindicated for corn-allergic patients if the vaccines contain ingredients derived from corn.

“Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17
https://responsibletechnology.org/wp-content/uploads/2017/06/Corn-Products-Derivatives-06-06-17.pdf

Vaccine Excipient Summary
https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

Thank you for your attention to this critical matter.

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References:

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

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

"Probable anaphylactic reaction to corn-derived dextrose solution."
https://www.ncbi.nlm.nih.gov/pubmed/1808842

BCPharmacists, "Warning: corn-related allergens . . ."
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

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

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

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

This anticoagulant product contains corn-derived ingredients, and should be contraindicated for corn-allergic patients.
ACD-A Anticoagulant Citrate Dextrose Solution, Solution A
http://www.citra-labs.com/products/acd-a.cfm

Dextrose (corn sugar derived from cornstarch) is NOT a drug, but is an ingredient added to drug products.
My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)
https://cornallergyadvocacyresources.blogspot.com/2020/03/email-to-fda-re-dextrose-corn-sugar-per.html

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)
https://cornallergyadvocacyresources.blogspot.com/2017/05/published-corn-allergy-studies.html

April, 2020, Month-End Corn Allergy Statistics: 919.3% Increase in 82 Months
https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

UPDATES:

Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health

[Corn is not designated as a potential allergen; a CRITICAL OMISSION.]

Potential Allergens in Vaccines per 0.5 mL dose

http://www.vaccinesafety.edu/components-Allergens.htm

Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health

Excipients in Vaccines per 0.5 mL dose

http://www.vaccinesafety.edu/components-Excipients.htm

STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED:

The FDA recommends strict avoidance of one's allergen.

"Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms, some food allergies can cause severe reactions, and may even be life-threatening.

There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are important measures to prevent serious health consequences."

https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/ucm079311.htm

The ACAAI also recommends strict avoidance:

“Symptoms of a food allergy can range from mild to severe. Just because an initial reaction causes few problems doesn’t mean that all reactions will be similar; a food that triggered only mild symptoms on one occasion may cause more severe symptoms at another time.”

https://acaai.org/allergies/types/food-allergy

"Patient education: Food allergy treatment and avoidance (Beyond the Basics)," Scott H. Sicherer, MD, FAAAAI, UpToDate, April 25, 2017

"People with food allergies can have serious or even life-threatening reactions after consuming certain foods. The most important strategy in the management of food allergies is to avoid eating these foods."

https://www.uptodate.com/contents/food-allergy-treatment-and-avoidance-beyond-the-basics

"Even a tiny amount of the allergy-causing food can trigger signs and symptoms . . ."

https://www.mayoclinic.org/diseases-conditions/food-allergy/symptoms-causes/syc-20355095

Food Allergy & Anaphylaxis Connection Team (FAACT)

"Although food allergy desensitizations are being studied, these are not yet proven treatments, so strict avoidance is the only way to prevent an allergic reaction. 

Trace amounts of an allergen can trigger an allergic reaction in some individuals."

https://www.foodallergyawareness.org/foodallergy/