In response to my inquiries to
the FDA in 2018 addressing corn labeling in food products (Case #00167188, #00167300,
and #00168167), the FDA specifically stated that: “. . . while corn is not one of the eight major
allergens, it still must be listed as an ingredient in foods that contain corn.
Corn is not exempt from FDA labeling requirements.” (emphasis added) [1]
Since the FDA made this
declaration in 2018, I have been contesting their reply due to testimonies from
the 12K+ members in our corn allergy support groups. If corn is, in fact, NOT exempt from FDA
labeling requirements, it would not be a daily struggle for survival for the
corn allergy community. [2-6]
THE FDA CONFIRMS THAT CORN IS EXEMPT FROM FDA
LABELING REQUIREMENTS
The FDA did not address the exemption of corn labeling in
other products regulated by their agency; however, based on our personal
experiences, we can assume that corn is also exempt from these products as
well; e.g., “The FDA regulates a wide range of products, including foods
(except for aspects of some meat, poultry and egg products, which are regulated
by the U.S. Department of Agriculture); human and veterinary drugs; vaccines
and other biological products; medical devices intended for human use;
radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products.” [7, 8-15]
My
June 8, 2020, Inquiry to the FDA Re: Conflicting Statements by the FDA
Addressing Corn Labeling Requirements, Case #236408
“Based on the prior response by the FDA (Case #00167188,
#00167300, and #00168167), which stated that “Corn is not exempt from FDA
labeling requirements;” for the safety of corn-allergic consumers, we are
appealing to the FDA to respond to this inquiry. The following products contain
corn, so please explain why these manufacturers are not in violation of FDA
labeling requirements.
1. Ingredients:
Vegetable Oil (Soybean and/or Canola), Water, Sugar, Salt, Nonfat Buttermilk,
Egg Yolk, Natural Flavors, Less Than 1% of: Spices, Garlic*, Onion*, Vinegar,
Phosphoric Acid, Xanthan Gum, Modified Food Starch, Monosodium Glutamate,
Artificial Flavors, Disodium Phosphate, Sorbic Acid and Calcium Disodium EDTA
Added to Preserve Freshness, Disodium Inosinate & Guanylate.
*Dried
Contains: Milk, Soy, Egg.
[WHERE'S THE CORN?]
2. INGREDIENTS:
Cranberry Juice (water, cranberry juice concentrate), Grape Juice (water, grape
juice concentrate), Apple Juice (water, apple juice concentrate), Pear Juice
(water, pear juice concentrate), Natural Flavor, Pectin, Ascorbic Acid (vitamin
C).
[WHERE'S THE CORN?]
3. Ingredients:
TOMATO PUREE (WATER, TOMATO PASTE), DICED TOMATOES IN TOMATO
JUICE, SUGAR, GARLIC, DRIED ONION, SEA SALT, BASIL, EXTRA VIRGIN OLIVE OIL,
CITRIC ACID (ACIDITY REGULATOR), OREGANO.
[WHERE'S THE CORN?]
4. INGREDIENTS.
Filtered Water, Coconut Oil, Food Starch-Modified (Potato & Tapioca), Sea
Salt, Calcium Citrate, Cheddar Flavor (Vegan Sources), Sorbic Acid and/or Olive
Extract (as a preservative), Beta Carotene & Paprika Extract (Color)
[WHERE'S THE CORN?]
Since corn is not labeled on these product labels, it could
prove fatal to anaphylactic corn-allergic consumers.
POSSIBLE
LIFE-THREATENING SCENARIO DUE TO THE LACK OF CORN LABELING:
"A 17-year-old girl was diagnosed with an IgE-mediated
allergy to corn, and was prescribed an epinephrine pen. The girl and her
parents thought this meant just eliminating corn kernels from her diet, since
her allergist didn't advise them of any other products to avoid. The teenager
went shopping with her girlfriends, fully aware that she must avoid corn. However, she suffered an anaphylactic
reaction after drinking a bottle of 100% pure fruit juice; and died in the
presence of her friends, and before the paramedics could treat her. Sadly, she didn't have her epinephrine pen
readily available, because she didn't suspect that she was consuming corn. Her parents discovered that this particular
brand of fruit juice contained ascorbic acid (confirmed that this was the
source of the corn in this product).""
June 9, 2020,
Response from the FDA, Case #236408
“The Food
and Drug Administration’s (FDA) Food and Cosmetic Information Center
(FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 236408.
Response:
Thank you for your inquiry.
Congress designated eight
foods or food groups as "major food allergens." These foods or food
groups account for 90 percent of all food allergies. Although there are other
foods to which sensitive individuals may react, the labels of packaged foods
containing these other allergens are not required to be in compliance with Food
Allergen Labeling Consumer Protection Act. If you feel that the products you
have mentioned in your email are improperly labeled, please submit a complaint
with the
FDA
Consumer Complaint Coordinator designated to serve your state.
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.
This
communication is intended for the exclusive use of the inquirer and does not
constitute an advisory opinion (21 CFR 10.85(k)). Also note that this
response is not intended to be a comprehensive list of all applicable
requirements. Please check FDA’s web page (
www.fda.gov) regularly for guidance reflecting our current thinking.
Additional information on FSMA can be found on FDA’s FSMA web page (
www.fda.gov/fsma).”
My June 13, 2020, Inquiry
to the FDA to Request Final Determination Re: Corn Labeling in Foods, Case
#236854
“Re: Case #00167188, #00167300, #00168167, #236408
We
would appreciate a final determination from the FDA for the above-referenced
case numbers, since there appears to be a discrepancy with the answers we
received from the FDA. Please note that
we are aware that since corn is not an "official allergen," corn
allergen warnings are exempt from FDA labeling requirements.
Based
on the FDA's most recent response to our inquiry, Case #236408, it appears that
the FDA has made a final determination that "Corn is, in fact, exempt from
FDA labeling requirements."
Is this
correct?”
June 14, 2020, Response from the
FDA, Case #236854
“The Food
and Drug Administration’s (FDA) Food and Cosmetic Information Center
(FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 236854.
Response:
Thank you for your inquires
[sic] regarding food allergen labeling.
The best information I can
point you to regarding the labeling of allergens on FDA regulated food products
can be found on the FDA webpage:
Please see question #6
which states:
Are there food allergens
other than those directly addressed by FALCPA?
Congress designated eight
foods or food groups as "major food allergens." These foods or food
groups account for 90 percent of all food allergies. Although there are other foods to which sensitive individuals may
react, the labels of packaged foods containing these other allergens are not
required to be in compliance with FALCPA.
(emphasis added)
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.
This communication is
intended for the exclusive use of the inquirer and does not constitute an
advisory opinion (21 CFR 10.85(k)). Also
note that this response is not intended to be a comprehensive list of all
applicable requirements. Please check
FDA’s web page (www.fda.gov) regularly for guidance reflecting our current
thinking. Additional information on FSMA
can be found on FDA’s FSMA web page (www.fda.gov/fsma)."
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter: @CornAllergy911
References:
[1] Corn/Corn-Derived
Ingredients are Required on Food Labels, FDA's FCIC/TAN
[2] FDA ADDRESSED MY INQUIRY RE: ABSORBENT PADS
USED FOR FRESH FOOD PRODUCTS
[3] FDA ADDRESSED MY INQUIRY RE: FALSE
CORN-FREE CLAIMS BY COMPANIES WHOSE PRODUCTS CONTAIN INGREDIENTS DERIVED FROM
CORN
[4] FDA CONFIRMS CORNSTARCH USED IN PACKAGING
MATERIALS IS EXEMPT FROM PUBLIC DISCLOSURE
[5] FDA CONFIRMS STARCHES IN FOOD PRODUCTS MUST
BE IDENTIFIED BY THEIR COMMON OR USUAL NAME
[6] 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
[7] FDA Regulated Products
[8] PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE
UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
[9] My May 11, 2020, Email to the FDA Re:
Corn-Derived Excipients in Vaccines
[10] My March 5, 2020, Email to the FDA Re:
Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose
(Blood Sugar)
[11] My June 2, 2020, Email to the World Allergy Organization (WAO) Re: Prescribing
Drugs/Biologics for Patients with IgE-Mediated Allergies to Excipients
[12] 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"
[13] My June 8, 2020, Appeal to My State
Congressional Representatives Requesting Contraindication Warnings for
Drug/Biologic Products Based on the “Source of Excipients”
[14] My June 16, 2020, Email to the FDA Re:
Corn Labeling in Drug/Biologic Products
[15] PHARMACISTS CONFIRM THE STUDY OF NMIs
(NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
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.)
Corn Allergy: A Potentially Life-Threatening
Diagnosis
Corn Allergy Statistics (Monthly)
Corn Products/Derivatives to Avoid with a Corn
Allergy
[Imagine if this article was entitled:
"Sesame Seed: It's Everything"]
Corn: It's Everything, Iowa Corn
