Thursday, May 30, 2019

May, 2019, Month-End Corn Allergy Statistics


In one corn allergy group of 9,066 members (170* of whom are anaphylactic to corn), there has been an 806.6% increase in corn allergies in the last 71 months, with an average of 113.6 new members/month.

*Poll taken in May, 2017:  Members prescribed epinephrine auto-injector pens as a result of their allergy to corn.


Corn Allergy Symptoms:
American College of Allegy, Asthma & Immunology

WebMD

Healthline


Corn products/derivatives to avoid if you are allergic to corn


Data Collection Methods:



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


Source:
“Corn Allergy,” Wikipedia
“External Links: Corn Allergy and Intolerance Online support group for corn allergy and intolerance.”


Tuesday, May 14, 2019

Food Allergy Research and Education (FARE) Patient Registry


It is my hope that the prevalence of corn allergies will finally be revealed as a result of this survey.

“Food allergy is a serious health condition, but you can make a difference. Help speed the search for better treatments by enrolling in the FARE Patient Registry.

Sign up and join a community of more than 7,000 patients and families. We continue to add new surveys to help you share your experiences and advance our understanding of food allergy.

Food allergy is a serious and growing public health issue. Approximately 15 million Americans have food allergies, including 1 in 13 children. Every three minutes, someone is taken to the emergency room for a food allergy reaction in the United States, and the underlying causes of food allergy and its rapid rise in recent years is still unknown.

FARE’s Patient Registry seeks to answer these questions – and achieve so much more as we work to accelerate research in the area of food allergy. The information you provide will help foster new directions in research to better understand how food allergies affect individual patients and what therapies can be developed to help them. Your participation may help us discover new ways to improve patients’ lives and connect individuals and families to new and innovative clinical trials nationwide.

What are the potential benefits of participating?
You may not benefit directly from participating in the FARE Patient Registry. You may receive information that you find helpful, such as information about the FARE Patient Registry study or food allergies.  The information collected by the FARE Patient Registry may help researchers gain a better understanding of food allergies and may lead to better diagnostic tests and treatments.  By taking surveys you may learn about FARE Patient Registry research findings, including how your answers compare with those of other food allergy patients and new discoveries made by FARE research programs.
What are the potential risks of participating?
There are no major risks associated with participation in this study.  None of the surveys or tools used in the FARE Patient Registry study are interventional, invasive or experimental and involve minimal risk as described hereafter.  Although we will take every precaution to protect your personal information, there is a risk that your privacy may be compromised. In the unlikely situation where this happens, you will be notified right away. Keeping the information from your survey in a secure computer database will limit that risk, but does not eliminate it. FARE Patient Registry staff are trained on how to work with human research participants.   If you share your login and password with others, they may be able to access your account and self-reported survey answers.  There may be other risks that are currently unknown.
There may be risks of loss of privacy and confidentiality if the PDF copy of this consent form is viewed and/or stored on a personal electronic device (PED), especially if that PED is shared with other users or is lost, hacked, or subject to a search warrant or subpoena.
If you change your mind and no longer want to be part of the FARE Patient Registry, you may contact the FARE Patient Registry Coordinator by e-mail at fare.coordinator@altavoice.com. Your account will be deleted; however, data previously collected and de-identified before you decided to withdraw from the FARE Patient Registry cannot be retrieved.  The FARE Patient registry cannot retract the use of de-identified data from studies prior to the date you decided to opt-out.  In the event this study is terminated, FARE will maintain your participant data according to the terms of our Privacy Statement.
You may decide to not participate or you may leave the Registry at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.
This Registry is for research purposes only. The only alternative is to not participate in this Registry.
There is no cost to you for taking part in this Registry.
You will be told about any new information found during your participation in the Registry that may affect whether you want to continue to take part.”


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



Thursday, May 9, 2019

Foods and Drugs Falsely Advertised as "Corn Free" / My 5/8/19 Inquiry to the FDA


Apparently, the ppm (parts per million) regulation will not apply to corn-derived ingredients[1] in foods and drugs until corn is declared an official allergen subject to FDA labeling requirements.

I have filed numerous adverse reaction reports with my state FDA Consumer Complaint Coordinator (Adulterated or Misbranded Foods or Drugs [2]), with the requisite photos of the packaging, UPC Code, etc.  In addition, I have also filed reports with the FTC for false advertising claims.  However, these companies continue to advertise these reported products as corn free – endangering the lives of corn-allergic consumers.

In the event you experience a corn allergy reaction to a product that is labeled "corn free," refer to instructions for filing reports in the following links:

FDA Consumer Complaint Coordinators

FTC Filing a Complaint to Report False and Misleading Labeling


My May 8, 2019, inquiry to the Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN):

What is the current limit of ppm (parts per million) for a "corn-free" claim by food manufacturers?  Too many people in our corn allergy groups of over 11K members are experiencing allergic reactions to the majority of products advertised as "corn free." We are aware that corn is exempt from FDA labeling requirements; however, a company should not be allowed to make corn-free claims if these products contain corn-derived ingredients. I have filed adverse reaction reports with the FDA, but these companies continue to advertise their products as "corn free."


May 9, 2019, reply to my inquiry:

“Thank you for your inquiry to the FDA Food and Cosmetics Information Center.

You are asking about limits on "corn free" in food label claims.

FDA has not established such a threshold as you are describing.

As you are aware, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) has identified the eight most common major allergenic foods. These foods account for 90 percent of food allergic reactions, and are the food sources from which many other ingredients are derived (such as whey from milk).

Our website has a consumer Q&A on food allergen labeling. There, you can see the work done on gluten-free labeling. FALCPA called for study of the presence of gluten in food, which set the stage for establishing a threshold, through which FDA developed a rule on gluten-free labeling.

Please see a section on Qualified Health Claims and the criteria established for manufacturers to pursue in seeking to use such label claims.

If you have encountered a product that claims to be corn-free and it is not, you can report it to an FDA Consumer Complaint Coordinator in your area, who can investigate the matter further. In Florida, where you reside (based on your zip code), you can speak with an FDA Consumer Complaint Coordinator at 866-337-6272 (toll free). Thank you.

Thank you for contacting FDA’s FCIC/TAN.

View popular Food Safety Modernization Act (FSMA) questions and answers identified by the Technical Assistance Network (TAN), on our website.”

[1] Corn products/derivatives to avoid if you are allergic to corn

[2] Title 21 U.S.C. - Section 343, Chapter 1 - Adulterated or Misbranded Foods or Drugs
https://www.law.cornell.edu/uscode/text/21/343



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



Sunday, May 5, 2019

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

            An allergy to corn should be considered a potentially life-threatening diagnosis since hospitals have not been mandated to stock corn-free foods, fluids, or medications for the safety of corn-allergic patients (corn is ubiquitous and exempt from FDA labeling requirements). We are currently required to supply our own previously-prepared corn-free products while hospitalized. My argument is: What if our admissions were due to an emergency? [I was denied care in 2018 when taken to a hospital via ambulance due to severe tachycardia. The hospital staff stated that they could not "touch me" due to my allergies. They only monitored me until my heart rate stabilized. The only guaranteed corn-free product on hospital premises is straight saline-only IV fluid.]

            It is a daily struggle to survive with an allergy to corn.  We can consume very few processed foods, and no commercially-manufactured non-organic meat, poultry, seafood, fruit, or produce due to FDA-mandated corn-derived acid washes. Due to corn cross-contamination, all organic foods must be soaked in a bath of filtered water, Bragg’s apple cider vinegar (white vinegar is derived from corn), and baking soda.  Many people allergic to corn struggle just to find safe drinking water due to corn-derived purification chemicals, and many are required to have their medications compounded to exclude corn (used as a common filler). Most insurance companies will not cover the cost of compounded drugs.  The testimonies from parents of corn-allergic infants (many of whom have been diagnosed with “failure to thrive”) are heartbreaking. There are no commercially-manufactured corn-free infant formulas, and hospitals are ill-equipped to treat/nourish these poor babies.

            The government removed safe, corn-free sources of foods, fluids, and medications from the corn allergy population without first establishing safe sources of these basic human requirements.

Reprinted with permission:  A mother’s desperate struggle to find safe water for her corn-allergic infant son.

M.R., Wausau, WI

“My corn allergic son (F.R.) cannot tolerate ingesting any bottled water or tap water. We had to purchase a ProPur Nomad with G2 filters. All food preparation and cooking or any oral contact (oral hygiene) has to be used with this safe water. I am breastfeeding him and I cannot ingest any other source of water either.

We also use a ProPur shower head filter for showering/bath due to his open skin/sores with eczema (reaction to corn).

Anytime we travel, we have to take both filters with us.”

Reference Documents:

My February 25, 2018, certified letter to the U.S. Department of Health & Human Services Re: mandate that hospitals stock corn-free foods, fluids, & drugs for the safety of corn-allergic patients.

My Submission to The Joint Commission on Behalf of Corn-Allergic Patients

Corn products/derivatives to avoid if you are allergic to corn

April, 2019, Month-End Corn Allergy Statistics: 799.0% Increase in 70 Months

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.)

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

"Corn: It's Everything," Iowa Corn



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

Friday, May 3, 2019

Pure Encapsulations® / Reported Corn Allergy Reactions


Over the last several years, there have been many reported corn allergy reactions to some of the Pure Encapsulations® supplements by members of our online corn allergy groups of over 11K members.  These supplements are manufactured by Atrium Innovations, Inc., and they list their other brands as Garden of Life®, Wobenzym®, AOV, Douglas Laboratories®, Genestra Brands, Klean Athlete®, Minami, Orthica, Pharmax, and Tropic

My April 30, 2019 Inquiry:

"Your products are often mentioned in our corn allergy groups of over 11K members. One of our members just mentioned that her physician contacted your company to inquire if any of your products contain corn (she should have asked if your products contain any ingredients DERIVED from corn). Her physician was told that none of your products contain corn; however, many of our members have reported corn allergy reactions to your products.

For the safety of the corn allergy community, we would like to finally resolve this issue. Do your products contain any corn-derived ingredients?

Thank you!"

Their May 1, 2019 Reply:

"Hello Diane,

Many of our ingredients, including vitamin C, B12 and B2 are derived from corn dextrose fermentation. This process starts with isolating dextrose from corn (a sugar, so does not contain allergenic corn protein), which is then fed to micro-organisms. The micro-organisms produce these nutrients, and the nutrients are then isolated and purified away from the starting materials.  While no corn proteins or sugar remain in the final product (and we have tested with negative results), we do not routinely test for corn allergens and therefore we would not be able to guarantee its safety for someone with a corn allergy.  I would add if you have a specific product in mind, please ask and I can investigate further."


My Personal Recommendation:

If you are allergic to corn, I would personally avoid consuming any of their products (including products from their other noted brands).  I have previously contacted Garden of Life® and Douglas Laboratories®.  Both companies confirmed that many of their products contain corn-derived ingredients; and, therefore, recommended that they be avoided by the corn allergy community.

I am concerned with their comment that dextrose [the sugar derived from corn] "does not contain allergenic corn protein."  If this were true, dextrose IV fluid would not contain a warning that dextrose IV fluid should not be administered to corn-allergic patients.  In addition, one of my most critical corn allergy reactions was to Morton's iodized salt.  Morton's confirmed that iodized salt contains corn-derived dextrose.   

Reference Documents:

After reading disturbing testimonies by members of our corn allergy groups that physicians insisted upon administering dextrose IV fluid to corn-allergic patients requiring immediate intervention with an antihistamine, it took me three years to forward the following product information sheet from Baxter Labs to our nation’s hospitals and colleges of medicine for the safety of corn-allergic patients.  One physician actually told a patient that “no one can be allergic to dextrose.”  Their lack of knowledge can endanger patients’ lives.  

After a compounding pharmacist told a corn-allergic patient that “cornstarch is not really corn,” I contacted the majority of world-wide pharmaceutical companies and our nation’s colleges of pharmacy.

Baxter Labs specifically warns about administering dextrose IV fluids to corn-allergic patients.
"Solutions containing dextrose should be used with caution, if at all, in patients with known allergy to corn or corn products." - Page 3

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

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

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

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

Pharmaceutical Companies 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

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



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

April, 2019, Month-End Corn Allergy Statistics


In one corn allergy group of 8,990 members (170* of whom are anaphylactic to corn), there has been a 799.0% increase in corn allergies in the last 70 months, with an average of 114.1 new members/month.

*Poll taken in May, 2017:  Members prescribed epinephrine auto-injector pens as a result of their allergy to corn.



Corn Allergy Symptoms:
American College of Allegy, Asthma & Immunology

WebMD

Healthline


Corn products/derivatives to avoid if you are allergic to corn


Data Collection Methods:



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


Source:
“Corn Allergy,” Wikipedia
“External Links: Corn Allergy and Intolerance Online support group for corn allergy and intolerance.”



Saturday, March 30, 2019

March, 2019, Month-End Corn Allergy Statistics


In one corn allergy group of 8,931 members (170* of whom are anaphylactic to corn), there has been a 793.1% increase in corn allergies in the last 69 months, with an average of 114.9 new members/month.

*Poll taken in May, 2017:  Members prescribed epinephrine auto-injector pens as a result of their allergy to corn.


Corn Allergy Symptoms:
American College of Allegy, Asthma & Immunology

WebMD

Healthline


Corn products/derivatives to avoid if you are allergic to corn


Data Collection Methods:



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


Source:
“Corn Allergy,” Wikipedia
“External Links: Corn Allergy and Intolerance Online support group for corn allergy and intolerance.”