Corn/Corn-Derived Ingredients are Required on Food Labels, FDA's FCIC/TAN

CRITICAL UPDATE, JUNE 16, 2020

FDA CONFIRMS THAT CORN IS EXEMPT FROM FDA LABELING REQUIREMENTS

https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-confirms-that-corn-is-exempt-from.html

(Revised June 20, 2018)

My First Inquiry to the FDA’s FCIC/TAN:

Corn-allergic patients are currently required to provide our own previously-prepared corn-free foods, liquids, and medications while hospitalized (the only corn-free product stocked by hospitals is straight, saline-only IV fluid). What would happen if our admissions were due to an emergency? Please let me know how to proceed with a request that hospitals be mandated to stock corn-free foods, fluids, and medications (compounded to exclude corn) for the safety of corn-allergic patients. After my surgery in March, 2017, the hospital could not comply with the surgeon-ordered, liquid-only diet; since all of the liquids they offered me contained corn even though my allergy to corn was clearly indicated in my medical records. The hospital failed in their responsibility to contact the manufacturers of each liquid to confirm if the products contained corn/corn derivatives.  Therefore, a corn allergy is potentially a life-threatening diagnosis; since hospitals are ill-equipped to treat/nourish us. Thank you!

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 00167188.

First Reply by the FDA’s FCIC/TAN, May 25, 2018:

Good afternoon, we are sorry to hear about your experience. We would like to offer a point of clarification: 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.]

Hospitals and other public health or medical facilities are not regulated by FDA. You may want to contact your state and local health officials to offer your suggestion regarding food service facilities in hospitals.

We hope this information is helpful.

Thank you for contacting FDA’s FCIC/TAN.

My Second Inquiry to the FDA’s FCIC/TAN:

Case 00167188: Food/Allergen [ ref:_00D60KbN0._500t0AfLBa:ref ]

The FDA representative responding to my inquiry does not understand that corn/corn derivatives, as of now, are EXEMPT from FDA labeling requirements. I have had a corn allergy for 10 years; and, as a result, I must contact manufacturers prior to consuming their products due to the fact that corn/corn derivatives do not have to be labeled; e.g., I experienced severe reactions to Mott's and Ocean Spray 100%-advertised "pure" fruit juices. When I contacted these companies, they explained that corn/corn-derived ingredients in their products (corn-derived ascorbic acid) were exempt from labeling requirements, since corn has not been declared an official allergen. The corn-derived ascorbic acid was "hidden" under "natural flavors." Another severe reaction was to Morton's iodized salt. Again, the company explained that their iodized salt contains corn-derived dextrose which is EXEMPT from FDA labeling requirements.

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 00167300.

Second Reply by the FDA’s FCIC/TAN, May 30, 2018:

Greetings. We are sorry to hear that you were unsatisfied with the response to case #00167188, but the answer provided to you was correct: products containing corn are not exempt from the FDA labeling requirements found in 21 CFR part 101. [Emphasis added.] However, as previously stated, corn is not one of the eight major allergens as defined by Federal law, namely the Food Allergen Labeling and Consumer Protection Act. If you feel that the legal definition of food allergens should be expanded to include corn, we encourage you to contact your elected officials.

Thank you for contacting FDA’s FCIC/TAN.

My Third Inquiry to the FDA’s FCIC/TAN:

Case 00167300: Complaint [ ref:_00D60KbN0._500t0AfRnX:ref ]

I called Mott's, Ocean Spray, and Morton's Salt companies on June 1, 2018. These companies (to which I experienced severe allergic reactions to the undeclared corn-derived ingredients in their products; e.g., corn-derived dextrose, corn-derived ascorbic acid) have explained to me over the last 10 years that due to the fact that corn has not been declared an official allergen, corn/corn derivatives are exempt from FDA labeling requirements. I explained to them that the FDA has stated to me, in writing, that corn/corn-derived ingredients must be labeled, and shared with them the FDA regulation you shared with me. I received a call from Morton's Salt on June 5, 2018; and, once again, they declared that they are not required to label corn in their products since corn has not been declared an official allergen (I cannot consume iodized salt due to corn-derived dextrose).

Every company I have contacted since I acquired an allergy to corn in 2008 (confirmed in 2011) have reiterated the same declaration. Only after corn is declared an official allergen will companies be required to label corn/corn-derived ingredients.

I have contacted all 535 members of Congress six times in the last 4 1/2 years. They, too, have confirmed that companies are exempt from labeling corn, because corn has not been declared an official allergen. 

My February 25, 2018, certified letter to the U.S. Department of Health & Human Services Re: mandate that hospitals stock corn-free foods, fluids, & medications for the safety of corn-allergic patients.
https://cornallergyadvocacyresources.blogspot.com/2018/02 

Third Reply by the FDA’s FCIC/TAN, June 20, 2018:

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 00168167. 

While we appreciate your interest in this subject, we cannot be of further assistance as the Federal laws and regulations are clear on the food labeling and allergen labeling requirements.  In hopes of clearing up your confusion, we will reiterate our previous explanations. We also encourage you to review our previous correspondence and the Federal regulations we have cited for further information.

Corn is not exempt from FDA labeling requirements. Per the Food, Drug, and Cosmetic Act (FD&C Act):

[A food shall be deemed to be misbranded] Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colors not required to be certified under section 721(c) 29 unless sold as spices, flavorings, or such colors, may be designated as spices, flavorings, and colorings without naming each. (Sec. 403(i))

This is further clarified in 21 CFR 101.4, which elaborates upon the requirements for ingredients to be listed on food labeling.

The FD&C Act also states that "The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded [is prohibited]" (Sec. 201(a)).

We hope this clarifies that foods containing corn must include that information in their ingredient lists.

Corn derivatives are not exempt from FDA labeling requirements.Contrary to your previous assertion, regardless of whether they are derived from corn or not, dextrose and ascorbic acid are not exempt from FDA's food labeling regulations as codified in 21 CFR part 101. They are NOT, however, subject to food allergen labeling requirements because corn is not one of the eight major allergens as defined by the Food Allergen Labeling and Consumer Protection Act. 

Dextrose and ascorbic acid must be identified as ingredients in foods that contain them as "dextrose" and "ascorbic acid."

Furthermore, ascorbic acid is typically used as a preservative or nutrient, not as a flavor. If it is included in a food or beverage as a preservative or nutrient, it cannot be "hidden" under natural flavors--it must be identified by name.

We hope this is helpful. 

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 ourwebsite.

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
@CornAllergy911