Tuesday, June 9, 2020

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


 MY APPEAL TO MEMBERS OF THE CORN ALLERGY COMMUNITY

Please contact your state congressional representatives to demand that they pass an emergency mandate requiring that drug/biologic manufacturers list contraindication warnings for these products based on the “source of the excipients.”

Thank you very much for your contribution to this effort.

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911

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

“What allergen restricts access to basic human requirements: fresh foods, water, drugs, and clothing? CORN!"

This is the title of the next article I am writing, which will include studies, statistics, and devastating personal testimonies confirming the daily struggle for survival with an allergy to corn [not recognized as an official allergen].

However, I want to address the lack of available drugs for corn-allergic patients immediately; since corn-derived excipients are not only used as common fillers in the majority of prescription/OTC drug/biologic products, but these drugs contain NO CONTRAINDICATION WARNING FOR ADMINISTRATION TO CORN-ALLERGIC PATIENTS BASED ON THE SOURCE OF THESE EXCIPIENTS. 

In our corn allergy support groups of over 12K members [note that this is more than double the members of sesame seed allergy support groups], we read testimonies daily of physicians prescribing drugs to their corn-allergic patients which contain inactive ingredients derived from corn; thereby, resulting in unnecessary allergic reactions (including anaphylaxis) to their patients.  This is due to the fact that drugs containing corn-derived excipients do not currently contain a contraindication warning for administration to corn-allergic patients based on the source of the excipients.* Since physicians and pharmacists are not educated to understand the dangers of NMIs (non-medicinal ingredients) in drug/biologic products; and particularly since these drug/biologic products lack the critical contraindication warnings, these unfortunate incidents occur nearly every day.

Reprinted with permission (pharmacist who is 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

I have just forwarded an appeal to the FDA to pass an emergency mandate requiring that drug/biologic product manufacturers be required to list contraindication warnings based on the 'SOURCE OF EXCIPIENTS' in these products for the safety of all patients diagnosed with allergies.     

I also forwarded this appeal to the majority of pharmaceutical companies with a hope that they will immediately adopt this practice prior to a mandate being issued. 

We would appreciate your assistance on behalf of all citizens suffering with allergies.

Sincerely,
Diane H., Corn Allergy Advocate

*There are only a handful of drugs containing this warning; e.g., IV drugs w/dextrose (corn sugar derived from cornstarch per Code of Federal Regulation 21CFR184.1857), and even these contraindication warnings are inconsistent.  Due to the fact that most physicians continue to miss this critical contraindication warning on IV fluids w/dextrose, it took me three years to forward the package insert to our nation's hospitals, colleges of medicine, and colleges of pharmacy."

References:

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"

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

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

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

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

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

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

Corn Allergy for Newbies

Corn Allergy: A Potentially Life-Threatening Diagnosis

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE

A mother's desperate struggle to find safe water for her corn-allergic infant son.

May, 2020, Month-End Corn Allergy Statistics: 935.2% Increase in 83 Months
(Corn is ubiquitous and corn allergen warnings are voluntary.)


Source:

Senators of the 116th Congress
https://www.senate.gov/general/contact_information/senators_cfm.cfm

United States House of Representatives 116th Congress


Saturday, June 6, 2020

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"

(Updated June 8, 2020, to include Facebook message sent to my state congressional representatives.)



ADDENDUM ADDED FOR PATIENTS WITH IgE-MEDIATED ALLERGIES

Pharmacists are not educated in recognizing the dangers of NMIs (non-medicinal ingredients) in drugs. For example, if you inform your pharmacist that you are allergic to corn, the pharmacist only relies on the contraindication warnings provided by the drug/biologic product manufacturers. Therefore, the pharmacist has no idea that Atenolol, which clearly contains corn-derived excipients, would be contraindicated for corn-allergic patients; since the manufacturer has not declared that this drug is contraindicated for corn-allergic patients. Pharmacists also trust that the prescribing physician is prescribing drugs that are safe for a particular patient, since physicians maintain the patient's medical records with a list of their allergens. Thus, the primary responsibility rests with the patient's physician to guarantee that the drugs they prescribe do not contain their patient's allergen, or derivative thereof.

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

To:      KC, Pharmacist
           Division of Drug Information
           Center for Drug Evaluation and Research
           druginfo@fda.hhs.gov

Re:      Emergency Mandate Requiring Contraindication Warnings be
Listed for Drug/Biologic Products Based on the "Source of Excipients"

Due to my concern that physicians routinely prescribe drugs containing a patient's allergen (or derivative thereof), particularly when their allergen is clearly documented in their medical records; I sent the following email to the World Allergy Organization addressing this issue.  After conducting my own research, apparently the responsibility rests solely with the prescribing physician to guarantee that the prescribed medication does not contain the patient's allergen, or derivative thereof.  Therefore, it is the physician's responsibility to know the source of all inactive ingredients derived from corn (or any other source) commonly found in drug/biologic products prior to prescribing drugs.  It doesn't matter that a particular drug lacks a contraindication warning based on the source of these excipients; e.g., Atenolol from one pharmaceutical company should contain a contraindication warning for administration to corn-allergic patients due to corn-derived excipients.  It is the physician's responsibility to contact each drug manufacturer to confirm the source of excipients for the safety of the physician's patients; and the fact that corn has not been declared an official allergen does not exempt the physician from potential liability for prescribing a drug containing corn-derived excipients to his/her corn-allergic patient.  Lack of knowledge is not an excuse; e.g., a physician cannot claim that he/she prescribed a drug or vaccine containing corn-derived excipients based on the egregious false definition of dextrose posted on the Drugs.com website, or the equally-egregious claim posted on the Children's Hospital of Philadelphia's website, "Corn Allergies and Vaccines."  I have forwarded my rebuttals/documentation to Drugs.com in addition to the Children's Hospital of Philadelphia.  I have also provided documentation to Dr. Paul Offit, contributor to this article, in an effort to protect the lives of corn-allergic patients.   

Thank you for your 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:

My June 2, 2020, Email to the World Allergy Organization (WAO)
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-2-2020-email-to-world-allergy.html

ATENOLOL AND CHLORTHALIDONE tablet
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6794dfa-adbb-491b-9d48-f89a44e866c5

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 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

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2020/04/petition-medicalbiologic-products-with.html

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

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

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

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

[It is the physician's responsibility to identify corn-derived excipients in drug/biologic products prior to prescribing for corn-allergic patients.  This also applies to the source of other excipients not derived from corn for the safety of all patients with a variety of IgE-mediated allergies.]
Corn products/derivatives to avoid if you are allergic to corn
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html


UPDATE:


June 8, 2020

Facebook message sent to my state congressional representatives with my urgent request that contraindication warnings be listed for drug/biologic products based on the "Source of Excipients"

"What allergen restricts access to basic human requirements: fresh food, water, drugs, and clothing? CORN!"

This is the title of the next article I am writing, which will include studies, statistics, and devastating personal testimonies confirming the daily struggle for survival with an allergy to corn [not recognized as an official allergen].

However, I want to address the lack of available drugs for corn-allergic patients immediately; since corn-derived excipients are not only used as common fillers in the majority of prescription/OTC drug/biologic products, but these drugs contain NO CONTRAINDICATION WARNING FOR ADMINISTRATION TO CORN-ALLERGIC PATIENTS BASED ON THE SOURCE OF THESE EXCIPIENTS. 

In our corn allergy support groups of over 12K members [note that this is more than double the members of sesame seed allergy support groups], we read testimonies daily of physicians prescribing drugs to their corn-allergic patients which contain inactive ingredients derived from corn; thereby, resulting in unnecessary allergic reactions (including anaphylaxis) to their patients.  This is due to the fact that drugs containing corn-derived excipients do not currently contain a contraindication warning for administration to corn-allergic patients based on the source of the excipients.* Since physicians and pharmacists are not educated to understand the dangers of NMIs (non-medicinal ingredients) in drug/biologic products; and particularly since these drug/biologic products lack the critical contraindication warnings, these unfortunate incidents occur nearly every day.

Reprinted with permission (pharmacist who is 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

I have just forwarded an appeal to the FDA to pass an emergency mandate requiring that drug/biologic product manufacturers be required to list contraindication warnings based on the 'SOURCE OF EXCIPIENTS' in these products for the safety of all patients diagnosed with allergies.     

I also forwarded this appeal to the majority of pharmaceutical companies with a hope that they will immediately adopt this practice prior to a mandate being issued. 

We would appreciate your assistance on behalf of all citizens suffering with allergies.

Sincerely,
Diane H., Corn Allergy Advocate

*There are only a handful of drugs containing this warning; e.g., IV drugs w/dextrose (corn sugar derived from cornstarch per Code of Federal Regulation 21CFR184.1857), and even these contraindication warnings are inconsistent.  Due to the fact that most physicians continue to miss this critical contraindication warning on IV fluids w/dextrose, it took me three years to forward the package insert to our nation's hospitals, colleges of medicine, and colleges of pharmacy

References:

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"

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

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

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

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

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

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

Corn Allergy for Newbies

Corn Allergy: A Potentially Life-Threatening Diagnosis

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE

A mother's desperate struggle to find safe water for her corn-allergic infant son.

May, 2020, Month-End Corn Allergy Statistics: 935.2% Increase in 83 Months
(Corn is ubiquitous and corn allergen warnings are voluntary.)


Source:

Senators of the 116th Congress
https://www.senate.gov/general/contact_information/senators_cfm.cfm

United States House of Representatives 116th Congress


Tuesday, June 2, 2020

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


To:  World Allergy Organization, info@worldallergy.org

Re:  Prescribing Drug/Biologic Products to Patients with IgE-Mediated Allergies to Excipients

In our corn allergy support groups of over 12K members, we continue to receive reports of medical professionals administering Lactated Ringer’s in 5% Dextrose IV fluids to corn-allergic patients in direct violation of the contraindication warning on the package insert, even though I spent three years forwarding this package insert and other corn allergy documents to our nation’s hospitals, colleges of medicine, and colleges of pharmacy. In addition, we continue to receive reports that medical professionals routinely prescribe drugs to corn-allergic patients that  contain corn-derived excipients even though the patient’s allergy to corn is documented in their medical records.

The fact that corn has not been declared an official allergen is not an excuse for any medical professional to prescribe or administer drug or biologic products containing corn-derived excipients to corn-allergic patients.  Since pharmacists are not trained in their colleges of pharmacy to recognize the dangers of NMIs (non-medicinal ingredients) in drugs, we must be able to trust that medical professionals are capable of protecting us from our allergens when prescribing drug/biologic products.  

1.      I contacted the CDC and requested that they provide me with a list of their vaccines that contain corn-derived excipients, which would therefore be contraindicated for corn-allergic patients.  The CDC directed me to the FDA.

2.      The FDA couldn’t answer my question, and advised me to contact the drug and biologic manufacturers directly.

3.      I contacted Merck and GSK.  They told me they could not release this information to me, and stated they could only release the information to my allergist.  I explained to them that after my allergist diagnosed me with an IgE-mediated allergy to corn in 2011, he stated that he was not familiar with the complexities associated with corn allergies; so I conducted my own research in an effort to safely navigate this devastating allergy. They refused to release this information to me.

I also recently discovered that it is not the pharmacist’s responsibility to inform corn-allergic patients if a drug or biologic product contains corn-derived excipients, since they were not trained about the possible dangers of NMIs (non-medicinal ingredients) in drugs, or even how to identify excipients derived from corn.

Therefore, apparently the responsibility lies with our medical professionals to know which drugs and biologics contain corn-derived excipients.  Of course, since the word “corn” is rarely identified on drug labels containing corn-derived excipients, our physicians would need to contact each drug/biologic manufacturer each time a drug is prescribed – particularly since their formulations may change over time.  

Thank you for your attention to this critical concern. 

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911


References:

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

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

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines

[Since the FDA did not reply to my email, I called them, which is when they referred me directly to the vaccine manufacturers.]
My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines

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

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

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

Corn Allergy: A Potentially Life-Threatening Diagnosis

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

"Probable anaphylactic reaction to corn-derived dextrose solution."

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)

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.
May, 2020, Month-End Corn Allergy Statistics: 935.2% Increase in 83 Months

FDA CONFIRMS THAT CORN IS EXEMPT FROM FDA LABELING REQUIREMENTS
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-confirms-that-corn-is-exempt-from.html

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

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

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

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



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

[Note:  My pharmacist authorized me to summarize our discussion on behalf of corn-allergic patients without revealing his identity or name of the pharmacy.]

May 29, 2020, Discussion with My Pharmacist Re: Corn-Derived Excipients in Drugs:

As posted in corn allergy support group:

“I had a very enlightening discussion with my pharmacist this morning. He was very gracious to spare a few minutes of his time with me.

I first asked him if pharmacists have a drug reference book which lists the "source of inactive ingredients in drugs." After he looked puzzled by my question, I brought up the difficulty of corn-allergic patients to source safe drugs, since the majority of drugs contain corn-derived ingredients as fillers.

I then asked him if a patient is registered in their database as having an allergy to corn, would their database flag drugs containing corn-derived ingredients; thereby contraindicated for corn-allergic patients? He stated that they would have to make that determination through research.

With the utmost respect, I asked him if he knows the difference between dextrose and glucose. After thinking about it for a moment, he stated that these are forms of sugar. I agreed with him, but stated that there is a critical difference between glucose (blood sugar) and dextrose (corn sugar derived from cornstarch per the Code of Federal Regulation 21CFR184.1857), which is why IV fluids containing dextrose are contraindicated for administration to corn-allergic patients on the package insert. I also explained that I am aware that glucose and dextrose are "biochemically identical" per published literature; however, glucose (blood sugar) cannot provoke an allergic reaction; whereas, dextrose (corn sugar) can prove fatal to corn-allergic patients. He confirmed that he was not aware of this difference.

IMPORTANT UPDATE: Apparently, glucose (blood sugar) is NOT biochemically identical to dextrose (corn sugar).  I recently discovered that the molecular formula for dextrose (corn sugar) is C6H14O7.
https://pubchem.ncbi.nlm.nih.gov/compound/66370

I then asked him if he knows what ascorbic acid is, to which he replied "It’s vitamin C." I agreed; however, I pointed out that ascorbic acid is synthetic vitamin C which is usually derived from corn, and could provoke an allergic reaction to anyone with an allergy to corn.

After he revealed that he wasn’t aware of the source of magnesium stearate in response to my question, I then asked him if pharmacists are educated about the source of inactive ingredients in drugs in their colleges of pharmacy. He confirmed that they are not educated about the source of inactive ingredients in college, and thanked me for educating him about corn in drugs.

You may also want to respectfully question your own pharmacists. This is the type of documentation required to add to our FDA citizen's petition requesting that corn be declared an official allergen subject to FDA labeling requirements, since we can’t rely on pharmacists to protect us.”

Testimonies from corn allergy group members reprinted with permission:

[Note that a common complaint by our corn allergy group members is the fact that their physicians are aware of their allergy to corn, but still prescribe drugs containing ingredients derived from corn; and now it has been revealed that pharmacists are not educated about the dangers of NMIs (non-medicinal ingredients) in drugs.  Since the majority of drugs contain corn-derived excipients, many of our members are required to have their medications compounded to exclude corn-derived ingredients.  For these reasons, it is critical that corn allergen warnings be immediately mandated on all drug and biologic products for the safety of corn-allergic patients.] 

"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

"I basically had to get my entire list of no-nos to my pharmacist so that he could look them up individually as the need arises. He was entirely unaware and even had a difficult time getting answers from the manufacturers about where their ingredients were derived from whenever the source was not stated." - D.D.

" I have had a 20 year relationship with my compounding pharmacists and I have had to educate them over the years. They haven't any idea which inactive ingredients are corn derived, so whenever they look up drugs in their pharmaceutical book, or check packaging for me, I get them to read out the ingredients and I tell them which inactive ingredients are likely derived from corn. It is a shame they are not taught the sources of inactive ingredients. My pharmacist also told me that inactive ingredients are purchased in huge vats for pharmaceutical companies, usually from China, and even they don't know the origins of the inactive ingredients they buy."  - S.P.

“The day that I offered the list of newly diagnosed food allergies to my daughters pharmacist, he essentially told me he didn’t need a list of food allergies because he couldn’t cross check them anyway. I then verified this with a few of the pharmacists and pharmacy techs that I work with and they verified for me that this is true. My daughter is required by her health insurance plan to get medications either from this pharmacy or their mail order pharmacy which would mean I would not even have a person to discuss this with. We now keep her at the bare minimum of medications for this reason.” – B.M.

My personal testimony related to compounded doxycycline:
Due to my life-threatening 7-week allergic reactions to most antibiotics (QT interval prolongation, and an 8-week acute reaction to the blue dye in doxycycline for which I was prescribed an Epi-Pen®), I was required to have doxycycline compounded to exclude all excipients. The compounding pharmacist asked me to provide him with the documentation for all of my allergens in the event the FDA requires proof for the need to have this drug compounded.  Even after I presented the pharmacist with my 16-page summary of each of my allergens with the corresponding derivatives, he asked me if I would like flavorings or sweeteners added – which I declined; since they are included in the list of corn-derived ingredients I have to avoid due to my allergy to corn. It was clear that my compounding pharmacist was not familiar with the dangers of NMIs (non-medicinal ingredients) in drugs.

    
Additional Published Corn Allergy Testimonies:

The Truth About Corn Allergy, MomLifeTV, LLC




Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911

References:

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

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

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

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]

ACD-A Anticoagulant Citrate Dextrose Solution, Solution A [NO CONTRAINDICATION WARNING]

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines

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

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

"Probable anaphylactic reaction to corn-derived dextrose solution."

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

Corn Allergy: A Potentially Life-Threatening Diagnosis

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.)

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)

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

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

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

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

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

Monday, June 1, 2020

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE



            Due to my IgE-mediated allergy to corn, I can consume very few processed foods and have limited access to commercially-processed fresh food products; e.g. meat, poultry, seafood, fruit, or produce due to government-authorized corn-derived antimicrobial chemical washes.  During the last year, I have experienced reactions to USDA-certified organic fresh produce, even after washing these fresh food products in a bath of cold filtered water, Bragg’s apple cider vinegar, and baking soda. 

          The FDA and USDA have now confirmed that all fresh food products (including organic fresh foods) may be treated with corn-derived antimicrobial chemical washes which are EXEMPT FROM PUBLIC DISCLOSURE; [1,2] therefore, corn-allergic consumers have limited access to commercially-processed fresh food products. 

          This raises a critical question.  Are these corn-derived antimicrobial chemical washes sourced from GMO or non-GMO corn?  The general public is unknowingly consuming corn with nearly every meal, and they may not be aware that these corn-derived chemical washes applied to our fresh food supply may be sourced from GMO corn; thereby, exposing the general public to potentially toxic pesticides in addition to other potentially toxic substances. [3,4]


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911


References:

[1] My Inquiry to the FDA, Case #231940:

"Since I am experiencing a corn allergy reaction to all commercially-processed fresh food products (including organic fresh foods), I can only assume that these products are processed using a corn-derived acid wash; e.g., corn-derived lactic acid or some other corn-derived acid wash. Therefore, I have to assume that these corn-derived acid washes are, in fact, exempt from FDA labeling requirements. Is this correct? Thank you very much."

[NOTE THAT CORN HAS NOT BEEN DECLARED AN OFFICIAL ALLERGEN.]

The FDA's April 17, 2020, reply to my inquiry, Case #231940:

"The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 231940.

Response:

Hello

The Food Allergen Labeling Consumer Protection Act (FALCPA) is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a "major food allergen " declare the presence of the allergen in the manner described by the law.

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


[2]  My April 15, 2020 Conversation with the USDA:

In my conversation on April 15, 2020, with Devin (USDA National Organic Program Division), 1-202-720-3252, he explained that suppliers of produce certified organic by the USDA are allowed to treat organic produce with corn-derived antimicrobial chemical washes which are exempt from public disclosure.

[3]
Yan P, Liu Z, Liu S, Yao L, Liu Y, Wu Y, Gong Z. Natural Occurrence of Deoxynivalenol and Its Acetylated Derivatives in Chinese Maize and Wheat Collected in 2017. Toxins (Basel). 2020 Mar 22;12(3):200. doi: 10.3390/toxins12030200. PMID: 32235760; PMCID: PMC715093
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150931/

[4]
"Maize and maize-based products contain the highest amounts of fumonisins . . . may contribute to various serious adverse health outcomes such as cancer and birth defects."
https://www.who.int/foodsafety/FSDigest_Fumonisins_EN.pdf


Additional References:

FDA's "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables"

Code of Federal Regulation 21CFR173.315 "Chemicals used in washing or to assist in the peeling of fruits and vegetables"
https://www.govinfo.gov/app/details/CFR-2012-title21-vol3/CFR-2012-title21-vol3-sec173-315

FDA CONFIRMS CORNSTARCH USED IN PACKAGING MATERIALS IS EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/05/fda-confirms-cornstarch-used-in.html

“Acids of Many Uses From Corn,” C L. Mehltretter
https://naldc.nal.usda.gov/download/IND43894163/PDF

Corn Allergy: A Potentially Life-Threatening Diagnosis
https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

Corn Allergy for Newbies

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

Corn Allergy References, 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.)




Blog Post Reference: 

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-and-usda-confirm-that-corn-derived.html

 

 

 


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