National Institute of
Standards and Technology
U.S. Department of Commerce
100 Bureau Drive
Gaithersburg, MD 20899
https://www.nist.gov/
Re: Protection of Corn-Allergic Citizens
The FDA has applied the
incorrect molecular formula (C6H12O6) to 21CFR184.1857, which defines corn
sugar produced from allergenic cornstarch, a/k/a dextrose/D-glucose. The molecular formula should be C6H14O7 to be
consistent with all other corn-derived sweeteners.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
Why is this of critical importance?
Based on personal testimonies
from the 16K+ members in our corn allergy support groups, clinicians are
telling corn-allergic patients:
"You cannot be allergic to dextrose, since dextrose is naturally
present in humans." Dextrose is the
chemical name for corn sugar produced from allergenic cornstarch/D-glucose,
which can prove fatal to anyone with an IgE-mediated allergy to corn. It is for this reason that corn sugar
(dextrose/D-glucose)-containing IV fluids are contraindicated for administration
to corn-allergic patients in the package insert. Corn-allergic
patients should not be required to educate our clinicians to guarantee our
safety.
Glucose:
blood sugar (lifeblood of all living organisms)
D-Glucose:
synthetic glucose (lab-created from cornstarch); analog/enantiomer of glucose
(NOT identical)
L-Glucose:
synthetic glucose (lab-created), analog/enantiomer of glucose (NOT identical)
Corn sugar from allergenic cornstarch:
Corn sugar = dextrose =
D-glucose
Corn sugar = D-glucose =
dextrose
Dextrose = corn sugar =
D-glucose
Dextrose = D-glucose = corn
sugar
D-glucose = corn sugar =
dextrose
D-glucose = dextrose = corn
sugar
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
"Solutions containing
dextrose should be used with caution, if at all, in patients with known allergy
to corn or corn products. D-Glucopyranose
monohydrate"
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf
"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
"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
I need to mail a certified letter to the appropriate agency addressing this critical matter. Please advise.
Thank you.
Diane H., Corn Allergy
Advocate
Corn Allergy
Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyinitiative@gmail.com
Twitter: @CornAllergy911
Blog Post Reference:
My March 28, 2022, Inquiry to
the National Institute of Standards and Technology for the Protection of
Corn-Allergic Citizens
https://cornallergyadvocacyresources.blogspot.com/2022/03/my-march-28-2022-inquiry-to-national.html