Saturday, February 10, 2018

Bluebonnet Nutritional Corporation Oral Challenge for Corn/Corn-Derived Ingredients


I have been conducting oral challenges of products advertised as "corn free" by the manufacturer.  If I experience a corn allergy reaction, I then file reports with the manufacturer, the FDA, and the FTC. 

January 31, 2018
Failed oral challenge of Bluebonnet B-Complex 50 Capsules
UPC Code 743715004122
Lot #70601201
EXP 0620

I took one capsule at 3:07 pm, and my corn allergy reaction began at 3:28 pm. Since this product was labeled as “free from corn,” I left a message with Bluebonnet Nutritional Corporation at 3:45 pm. My reaction to this product was a rapidly-expanding belly (very uncomfortable), with another "corn baby" developing.  I took an antihistamine at 4 pm. 

I received a call from Marilyn, Customer Service Manager for Bluebonnet Nutritional Corporation; and after conducting further research, they discovered that the inositol is grown on phytin which is derived from corn. Therefore, they are removing their corn-free claims from their website and packaging in the near future.  I thanked her for their efforts on behalf of the corn allergy community.


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:

Non-FDA-Compliant "Corn-Free" Claims (Revised 11/16/17); Title 21 U.S.C. - Section 343, Chapter 1 - Adulterated or Misbranded Foods or Drugs

FTC Filing a Complaint to Report False and Misleading Labeling


WARNING:
  I strongly recommend that you do not attempt any oral food challenges unless you are in the presence of your physician.


UPDATE JUNE 18, 2018:
I filed an adverse reaction report with the FDA.


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




Friday, February 9, 2018

free2b Oral Challenge for Corn/Corn-Derived Ingredients


I have been conducting oral challenges of products advertised as "corn free" by the manufacturer.  If I experience a corn allergy reaction, I then file reports with the manufacturer, the FDA, and the FTC. 

I conducted an oral challenge today of free2b "Snack Breaks, Cranberry Pumpkin Seed Dark Chocolate," and didn't experience any allergic reaction (pleasantly surprised!).  Although I have discovered this product is "safe for me," it may not be safe for everyone. 

For allergy comparison, my corn allergy tested at 1+ on skin-scratch testing in 2011; however, my reactions to corn/corn derivatives have significantly escalated in the last couple of years.


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:

Non-FDA-Compliant "Corn-Free" Claims (Revised 11/16/17); Title 21 U.S.C. - Section 343, Chapter 1 - Adulterated or Misbranded Foods or Drugs



FTC Filing a Complaint to Report False and Misleading Labeling



WARNING:
  I strongly recommend that you do not attempt any oral food challenges unless you are in the presence of your physician.



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

Sunday, February 4, 2018

ACAAI - My Rebuttal Concerning Cornstarch and High Fructose Corn Syrup


The American College of Allergy, Asthma and Immunology (ACAAI) posted the following statement on their website (Google "corn allergy and cornstarch").  I already filed a report with Google indicating that this statement can endanger the lives of the corn allergy population, and requested that the cached Google reference be removed immediately.

"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."  ACAAI

Since their statement is extremely dangerous, false, and misleading; I urge everyone to contact them (make sure you reference their statement when you contact them).  In addition, many physicians are accepting their statements as fact without questioning the validity of their claims.

Telephone number (Arlington Heights, IL):  (847) 427-1200.

Twitter:  @ACAAI

Facebook (they accept messages):

Email:  mail@acaai.org


My Rebuttal Tweets:

Wikipedia also mentions that cornstarch and corn syrup must be avoided with an allergy to corn.  For the safety of the corn allergy population, please remove your statement that these products are safe for consumption.

Mayo Clinic states that "Even a tiny amount of the allergy-causing food can trigger signs and symptoms . . ."  A few grains of iodized salt w/corn-derived dextrose or a minute amount of cornstarch or corn syrup causes me to have a severe reaction.

"Allergy Symptoms of High Fructose Corn Syrup," Aglaee Jacob, SFGATE
"If you have a corn allergy, a corn intolerance or fructose malabsorption problem, eating foods sweetened with HFCS can cause mild to serious symptoms."

I just reported your post to Google, requesting it be removed from "Google search" for the safety of the corn allergy population.  I also sent Google the following link which refutes your false and misleading claims.
"Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic"

"The lowdown on maize allergies," health24 Allergy, May 24, 2017

"Allergy Symptoms of High Fructose Corn Syrup, Diane Marks, October 3, 2017, LIVESTRONG.COM

This Google search post by the ACAAI contradicts your own narrative concerning corn allergies:

 "Anaphylaxis due to cornstarch surgical glove powder"

Some of our corn allergy group members have taken screen shots of this dangerous post on Google search.  We will continue to monitor it until it is removed for the safety of the corn allergy population.

I only tested at 1+ (skin-scratch testing) for my allergy to corn, and my reactions to cornstarch and high fructose corn syrup are SEVERE!  I must avoid these products for my own safety.

An allergy to corn (includes anything derived from corn) is just as dangerous as an allergy to the top 8 allergens, and MUST BE AVOIDED!  Please do NOT continue to espouse this potentially life-threatening narrative.

YOUR WEBSITE POST: "While any food can cause an adverse reaction . . ."  Please explain why you are discounting critical, potentially life-threatening reactions to corn/corn derivatives.

Due to false narratives such as yours, I just spent the last 3 yrs. contacting the majority of U.S. hospitals for the safety of corn-allergic patients.
United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients

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

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

“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

"Ingredients Derived From Corn - What to Avoid," By Sharon Rosen, Live Corn Free

"Corn-Free Diet," Golisano Children's Hospital, Pediatric Nutrition

Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman

I would like the ACAAI to advocate for strict avoidance (published articles support this) of a person's allergen for their own safety.  A corn allergy can be just as lethal as any other allergy.  Thank you!

February 5, 2018 Update:
The ACAAI will be reviewing and revising their statements related to corn allergies in the near future.

February 14, 2018 Update:
Since they have made the decision to maintain this false and misleading statement on their website, I filed the following petition today with MoveOn.org.  For the safety of the corn allergy population, please join us in demanding that the ACAAI remove this potentially life-threatening claim.

PETITION

Demand that the ACAAI Remove False Statement Re: Cornstarch/High Fructose Corn Syrup





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


Sunday, December 31, 2017

My December 4, 2017, Email to Scott H. Sicherer, MD, FAAAAI

Dear Dr. Sicherer:

I read your article (referenced below), and was pleased to read your recommendation that people with allergies should avoid consuming their particular allergens.  In fact, I have read many articles recommending the same avoidance policy.  It is for this reason that I was alarmed by your following statement as it relates to corn allergies; and, for the safety of the corn allergy population, I appreciate that this article has been removed from the AAAAI website.  

I read heartbreaking daily testimonies from the 7,000+ members of our corn allergy group (one of many); particularly from parents of corn-allergic infants, due to the lack of commercially-manufactured corn-free formulas.  These parents are resorting to goat's and camel's milk in an effort to nourish these suffering babies, many of whom have been diagnosed with "failure to thrive" as a result of their allergy to corn.  Other members struggle just to find safe sources of drinking water (corn-derived purification chemicals in tap water), and many are required to have their medications compounded to exclude corn (common filler).  It is not just corn, but everything derived from corn that can actually be fatal to the anaphylactic corn-allergic individual.  Please understand that removing the corn "protein" does not render corn hypoallergenic (per numerous personal testimonies); and, thus, all corn/corn derivatives must be strictly avoided for anyone suffering with a corn allergy (also includes corn starch, corn syrup, glucose syrup, dextrose, or high fructose corn syrup, all corn-derived acids, etc.). 

I have recently shared other "Ask the Expert" articles with our corn allergy group that appear to approve the ingestion of corn/corn derivatives for corn-allergic patients.  As with any allergen, this advice can result in a life-threatening reaction; and it is my hope that the no further "Ask the Expert" articles reflect this recommendation.

Statements by Dr. Sicherer, “Avoidance of Corn Allergen," AAAAI, Ask the Expert, 2012
"From a clinical perspective, we use formulas that contain corn syrup and corn syrup solids without difficulty for patients who are allergic to corn. We therefore do not restrict a formula with these ingredients for a patient with corn allergy. However, we are not aware of specific allergenicity studies on these ingredients.

Corn starch is an ingredient that may have a very trace amount of corn protein (which probably has no clinical relevance for most people with a corn allergy). Baking powder contains corn starch, but the amount of baking powder ever used in a product is so small that the amount of corn starch would be even smaller, and, therefore, the amount of corn protein would be extremely miniscule- almost surely undetectable in a serving of such a product.

Corn starch (already with only very trace protein) is the starting material for corn syrup. The final products of corn syrup, glucose syrup, dextrose (granular) or high fructose corn syrup should have undetectable corn protein."

"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."

Thursday, December 14, 2017

Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman

WARNING:  NEVER ATTEMPT AN ORAL CHALLENGE IF
YOU ARE ANAPHYLACTIC TO YOUR ALLERGEN, WHICH SHOULD ONLY
BE CONDUCTED IN THE PRESENCE OF YOUR PHYSICIAN

December 14, 2017, Oral Challenge of Mazola Corn Oil
Since I am not anaphylactic* to corn, I conducted this oral challenge today to test the hypothesis presented by Dr. Phil Lieberman in the "Ask the Expert" article that appeared on the American Academy of Asthma Allergy & Immunology (AAAAI) website.  Thankfully, for the safety of the corn allergy population this article has since been removed from their website.

“Avoidance of Corn Allergen," AAAAI, Ask the Expert, 2012
https://www.aaaai.org/ask-the-expert/avoidance-corn-allergen

Statement by Phil Lieberman, MD
". . . the issue is complex because some products, such as corn oils, are labeled as having corn, but actually do not contain corn allergen."

Before conducting this oral challenge, I called ACH Food Companies, Inc. (manufacturer of Mazola corn oil), and read them Dr. Lieberman's statement.  They told me that Mazola corn oil contains corn; and, therefore, should be avoided by anyone with an allergy to corn.

My 12/14/17 email to Dr. Lieberman:
Dear Dr. Lieberman:
Per my email to you yesterday, I conducted an oral challenge today of Mazola corn oil.
Results prior to consuming corn oil:
Resting pulse rate: 56 bpm
BP: 96/65
Reactions after consuming Mazola corn oil (2 teaspoons):
Pounding heart with increased pulse rate (101 bpm) within 25 minutes of consumption. Two hours later, still experienced pounding heart w/increased pulse rate (92 bpm). I didn't experience any significant increase/decrease in my BP. Since I also experienced acute abdominal swelling, I took an antihistamine.
Conclusion:
Corn oil should be avoided by anyone with an allergy and/or intolerance to corn.

*Since I have never experienced an anaphylactic reaction to corn, I felt safe conducting this test since I had epinephrine auto-injector pens available (prescribed for my allergy to most antibiotics).  I strongly recommend that you do not attempt any oral challenge unless you are in the presence of your physician.

American College of Allergy, Asthma & Immunology (ACAAI)
"Because of the possibility of a severe reaction, an oral food challenge should be conducted only by experienced allergists in a doctor’s office or at a food challenge center, with emergency medication and equipment on hand."
http://acaai.org/allergies/types/food-allergy


Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

Wednesday, December 13, 2017

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

(Updated March 26, 2021)

I have read far too many personal testimonies in our corn allergy group of over 7,000 members [now 12K+ members] which confirm that the removal of corn "protein" does not guarantee corn hypoallergenic.  The next time a medical professional or manufacturing company declares to you that a particular product should be safe since the corn "protein" has been removed, please request that they produce the documentation to confirm their claim.  From the articles I have researched on this subject, it appears that this claim is false or misleading.

Personal Testimony (reprinted with permission by C.P.)
"I had a doctor prescribe a cream with refined peanut oil (dermasmoothe) knowing my daughter was anaphylactic to them. Guaranteed it would be safe. Put a little on her leg and she went into full body hives. I reported it and she still tried to prescribe it again! I refuse everything now and do my own research."

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

Pastorello EA, Pompei C, Pravettoni V, Farioli L, Calamari AM, Scibilia J, Robino AM, Conti A, Iametti S, Fortunato D, Bonomi S, Ortolani C. Lipid-transfer protein is the major maize allergen maintaining IgE-binding activity after cooking at 100 degrees C, as demonstrated in anaphylactic patients and patients with positive double-blind, placebo-controlled food challenge results. J Allergy Clin Immunol. 2003 Oct;112(4):775-83. doi: 10.1016/s0091-6749(03)01942-0. PMID: 14564361.

"CONCLUSIONS:  Maize LTP maintains its IgE-binding capacity after heat treatment, thus being the most eligible candidate for a causative role in severe anaphylactic reactions to both raw and cooked maize."
https://pubmed.ncbi.nlm.nih.gov/14564361/

"In general, allergenic foods are resistant to processes commonly used in food manufacturing. Nearly all the causative proteins (allergens) retain their allergenicity after treatment by heat and/or proteolysis. Notable exceptions exist . . ."
https://link.springer.com/chapter/10.1007/978-1-4615-4853-9_8

"Processing may influence, but does not abolish, the allergenic potential of proteins."
https://www.sciencedirect.com/science/article/pii/S0278691515000848

"A number of thermal and nonthermal food processing interventions have been tested on various allergenic foods to reduce their allergenicity. However, complicated food matrices and varied detection methods make it very challenging to apply a particular technology for reducing allergenicity."
https://www.researchgate.net/publication/319295806_Removal_of_Allergens_in_Some_Food_Products_Using_Ultrasound

"James R. Baker, Jr., MD and CEO and Chief Medical Officer of Food Allergy Research and Education, an advocacy group for people with food allergies, cautions, “we still have much to learn about the biology of an allergic response to a food protein. At this point, there are too many unanswered questions in the field of food allergy and in the specific research on hypoallergenic peanuts [or corn] to be able to foresee all of the challenges and implications that such a product would bring."
https://blogs.scientificamerican.com/guest-blog/allergy-free-peanuts-not-so-fast/

"10.4 Future Trends
Newer technologies, such as genetic modification, are being developed to reduce allergenicity by removing, silencing, or modifying the genes for specific allergenic proteins within foods . . . To date, however, there is no example of a food allergen that has been rendered completely devoid of allergenic activity using these methods.  This is due to the fact that each food contains a number of allergenic proteins, each with multiple allergenic epitopes.  Unless these methods can eliminate all of these proteins, or modify all allergenic epitopes, the remaining proteins or epitopes could still elicit a reaction in sensitive individuals (FDA, 2005)."
https://books.google.com/books?id=muZRAwAAQBAJ&pg=PA170&lpg=PA170&dq=does+removing+protein+from+an+allergen+render+it+hypoallergenic&source=bl&ots=xSF2FN7Yao&sig=yXmZyqzQ0YDSz_DMV7Bn55K8svo&hl=en&sa=X&ved=0ahUKEwiBiP6fsobYAhWF7yYKHTLUAoc4ChDoAQgmMAA#v=onepage&q=does%20removing%20protein%20from%20an%20allergen%20render%20it%20hypoallergenic&f=false

"Food allergens are proteins that are usually very resistant to heat, digestion, acid, and alkali.  Some food allergens have remarkable tenacity, and most food processing treatments do nothing to reduce their allergenicity."
https://books.google.com/books?id=U6LaBwAAQBAJ&pg=PA107&lpg=PA107&dq=does+removing+protein+from+an+allergen+render+it+hypoallergenic&source=bl&ots=jSkCyiKhtQ&sig=5tyJ8QI9zMSyKBJrqfSQihQCqJY&hl=en&sa=X&ved=0ahUKEwiihMOP_IXYAhXLSiYKHeDmDqEQ6AEIQzAE#v=onepage&q=does%20removing%20protein%20from%20an%20allergen%20render%20it%20hypoallergenic&f=false

"Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food," U.S. Food & Drug Administration, March 2006 

"3. Cross-Contact
[Note:  Since corn is ubiquitous and is currently exempt from FDA labeling requirements, cross-contact is a major cause of allergic reactions to the corn allergy population.]

Allergens, or proteins derived from allergenic foods, may be present in foods as the result of cross-contact during processing and handling. The term "cross-contact" describes the inadvertent introduction of an allergen into a product that would not intentionally contain that allergen as an ingredient. Cross-contact may occur when a residue or other trace amount of a food allergen is present on food contact surfaces, production machinery, or is air-borne, and unintentionally becomes incorporated into a product not intended to contain, and not labeled as containing, the allergen. Cross-contact may also result when multiple foods are produced in the same facility or on the same processing line, through the misuse of rework, as the result of ineffective cleaning, or may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment. Cross-contact of foods with allergens has been shown to lead to allergic reactions in consumers on numerous occasions (Gern et al., 1991; Jones et al., 1992; Yunginger et al., 1983). Much cross-contact can be avoided by controlling the production environment."
https://www.fda.gov/media/78205/download

CLEANING STRATEGIES TO REMOVE FOOD ALLERGENS AND TOOLS FOR DETERMINING EFFICACY
http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-712-49%252FPresentations%252FCleaning_for_Controlling_Allergens_CCFH.pdf

 

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

Additional References:

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

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

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

 

Blog Post Link:

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html


Council for Responsible Nutrition (CRN)

"The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers. CRN companies produce a large portion of the dietary supplements marketed in the United States and globally. Our member companies manufacture popular national brands as well as the store brands marketed by major supermarkets, drug stores and discount chains. These products also include those marketed through natural food stores and mainstream direct selling companies. CRN represents more than 150 companies that manufacture dietary ingredients and/or dietary supplements, or supply services to those suppliers and manufacturers. Our member companies are expected to comply with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety. Our supplier and manufacturer member companies also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics."

I contacted the CRN via Twitter, and explained to them that some of their members may not be complying with "federal and state regulations governing dietary supplements" with their corn-free claims.  Since corn is not yet an official allergen, thereby subject to FDA labeling requirements, they are not required to declare any corn/corn derivatives in their products; however, if their products contain corn/corn derivatives, they are prohibited from making corn-free claims.  If you suspect any dietary supplement and functional food manufacturers and ingredient suppliers are in violation of the following U.S.C. regulation, please contact the CRN immediately.

Council for Responsible Nutrition (CRN)
1828 L Street, NW, Suite 510
Washington, DC, 20036 - 5114
(202) 204 - 7700   Fax (202) 204 - 7701
Online Contact Form:  https://www.crnusa.org/contact-us
Twitter:  @CRN_Supplements

Non-FDA-Compliant "Corn-Free" Claims (Revised 11/16/17); Title 21 U.S.C. - Section 343, Chapter 1 - Adulterated or Misbranded Foods or Drugs

Clinicians: Protect Yourself From A Potential Medical Malpractice Lawsuit

  Pursuant to 21CFR184.1857, if a clinician injects any of the named substances listed in this CFR into a patient with a confirmed IgE-media...