August 5, 2022
Robert M. Califf, M.D. (CERTIFIED)
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Ciranda "Tapioca Dextrose" (Acute Allergic Reaction Reported to the FDA)
Dear Dr. Califf:
As you are aware, dextrose is corn sugar produced from cornstarch pursuant to 21CFR184.1857 [1] that can prove fatal to anyone with an IgE-mediated allergy to corn. It is for this reason that corn sugar produced from cornstarch (dextrose/D-glucose)-containing IV fluids are contraindicated for administration to corn-allergic patients in the package insert due to the presence of allergenic corn proteins. [2] Therefore, there is no such thing as "tapioca dextrose." It is tapioca starch to which corn sugar produced from cornstarch (dextrose/D-glucose) has been added to the product, since it is impossible to derive corn sugar produced from cornstarch (dextrose/D-glucose) from the tapioca plant.
Following is the false advertising of this product that endangers the lives of corn-allergic consumers:
"Tapioca Dextrose, Organic tapioca dextrose (glucose) . . ." [emphasis added]
https://www.ciranda.com/ingredients/syrups-sweeteners/tapioca-dextrose/tapioca-dextrose
Dextrose is D-glucose — not glucose; however, they are equating D-glucose (corn sugar produced from cornstarch/dextrose) with glucose (blood sugar essential for the survival of all living organisms). Humans do not have corn sugar produced from cornstarch (dextrose/D-glucose) naturally present in our bodies.
Glucose = blood sugar essential for the survival of all living organisms
D-Glucose = laboratory-created form of sugar produced from cornstarch (dextrose)
L-Glucose = laboratory-created form of sugar
Acute Allergic Reaction to this Product:
After I was made aware that some companies were selling "tapioca dextrose," I elected to conduct an oral challenge of the subject product for the safety of corn-allergic consumers, and suffered an acute allergic reaction.
[I strongly recommend against conducting an oral food challenge unless the patient is in the presence of their physician. Although I have not yet experienced an anaphylactic reaction to corn, I did have epinephrine auto-injector pens available.]
November 19, 2020: Oral challenge requiring 2 antihistamines and 2 prednisone tablets.
After reporting my acute, 8-hour allergic reaction (consumed 1 level tsp.) of this mislabeled food product to my FDA state consumer complaint coordinator with indisputable documentation this product was mislabeled, they told me they sent my complaint back to the FDA's Center for Food Safety and Applied Nutrition; even though I supplied them with the requisite documentation of my severe allergic reaction to "Organic Tapioca Dextrose" from a complimentary sample sent to me by Ciranda. It was actually tapioca starch to which corn sugar produced from cornstarch (dextrose/D-glucose) was added. The FDA has done nothing to address this critical issue.
NOTE: I still have the product available for inspection and testing by the FDA (one package remains unopened), and Ciranda continues to falsely advertise "Tapioca Dextrose."
Dr. Califf, I have personally forwarded indisputable documentation to all companies advertising "tapioca dextrose." Since this is false and misleading, several companies removed their deceptive advertising; however, for the safety of corn-allergic consumers, I believe the FDA should forward an industry-wide notification confirming that dextrose (corn sugar produced from cornstarch/D-glucose) cannot be derived from the tapioca plant or any other food product other than corn.
On behalf of corn-allergic citizens, I thank you for investigating this critical matter.
Sincerely,
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyiniitiative@gmail.com
Twitter: @CornAllergy911
References:
[1] Code of Federal Regulation 21CFR184.1857
Sec. 184.1857 Corn sugar.
"(a) Corn sugar (C6H12O6, CAS Reg. No. 50-99-7), commonly called D-glucose or dextrose, is the chemical [alpha]-D-glucopyranose. It occurs as the anhydrous or the monohydrate form and is produced by the complete hydrolysis of corn starch with safe and suitable acids or enzymes, followed by refinement and crystallization from the resulting hydrolysate."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
[2] "Dextrose-containing solutions pose a significant risk to patients allergic to corn. Dextrose used for IV fluids is prepared by the simple hydrolysis of cornstarch."
https://journals.lww.com/anesthesia-analgesia/Fulltext/2019/05000/Excipients_in_Anesthesia_Medications.11.aspx
Additional References:
"Corn must first be converted to corn sugar (dextrose, the common commercial name for D-glucose) . . ."
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/
Over a period of many decades, the "D-" modifier has been shortened to "glucose" for convenience purposes. Dextrose (D-glucose/corn sugar) is not naturally present in humans, and can prove fatal to individuals with an IgE-mediated allergy to corn.
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf
"Pharmacists are requested to use caution and be aware that many drugs and medications contain undisclosed potential allergens in the form of sugars, starches, and celluloses. Share the corn allergy example with prescribers . . ."
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf
The European Medicines Agency also confirms dextrose is ONLY derived from corn.
"Dextrose a sugar that is obtained from corn starch"
"Dextrans come from corn and potato starch; dextrose comes from corn."
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf
Wikipedia is intentionally endangering the lives of corn-allergic citizens; e.g. if you reference "dextrose" (corn sugar produced from cornstarch), you will be redirected to "glucose" (blood sugar). Dextrose (corn sugar) is not naturally present in humans.
https://en.wikipedia.org/wiki/Glucose
“Dextrose is an ALL-American sugar, derived from American corn, refined in American factories, distributed by American companies.”
FACT: Dextrose can prove FATAL to anyone w/an IgE-mediated allergy to corn.
https://candyprofessor.wordpress.com/2010/09/29/dextrose-all-american-corn-sugar/
My December 14, 2021, Email to the Board of Trustees, American Medical Association (AMA) Re: Dextrose (Corn Sugar) / Conflicting Molecular Formulas
https://cornallergyadvocacyresources.blogspot.com/2021/12/my-december-14-2021-email-to-board-of.html
Guidelines for reporting clinicians who administer corn sugar (dextrose/D-glucose)-containing IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html
My September 29, 2020, Email to Baxter Healthcare Ltd Re: Dextrose IV Fluid
https://cornallergyadvocacyresources.blogspot.com/2020/09/my-september-29-2020-email-to-baxter.html
Peer Review: A Direct Threat to the Safety of Corn-Allergic Citizens [DOCUMENTED]
https://cornallergyadvocacyresources.blogspot.com/2022/03/peer-review-direct-threat-to-safety-of.html
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