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: Mike's Mix "Tapioca Dextrose"
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, 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:
1. "Dextrose is synonymous with D-glucose or simply glucose . . ."
Dextrose is, in fact, D-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
2. "This product is gluten free and contains no corn [emphasis added] or wheat and is vegetarian and vegan. No artificial sweeteners or colorings of any sort. Only one ingredient: Pure Tapioca Dextrose." [emphasis added]
https://mikesmixture.com/products/tapioca-dextrose
This product does, in fact, contain corn sugar produced from cornstarch (dextrose/D-glucose) that can prove fatal to anyone with an IgE-mediated allergy to corn.
I have personally provided this company with indisputable documentation that their product is not free from corn; however, they refuse to correct these false statements.
Dr. Califf, for the safety of corn-allergic citizens, I am appealing to you to investigate this company's false and misleading claims with a demand that they immediately correct these false statements.
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
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