The Association of Food
and Drug Officials (AFDO)
155 West Market St., 3rd
Floor
York, PA 17401
https://www.afdo.org/
Email: afdo@afdo.org
(717) 757-2888
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
Additional
References
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
My December 3, 2021,
Email to the National Library of Medicine/FDA/PDR Re: Revision of PubChem CID
22814120 (Dextrose Monohydrate)
https://cornallergyadvocacyresources.blogspot.com/2021/12/my-december-3-2021-email-to-national.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
Nutritive
Sweeteners From Corn, Corn Refiners Association, 2006
https://corn.org/wp-content/uploads/2018/10/NSFC2006.pdf
Blog Post Reference:
My
March 28, 2022, Email to The Association of Food and Drug Officials (AFDO) for
the Protection of Corn-Allergic Citizens
https://cornallergyadvocacyresources.blogspot.com/2022/03/my-march-28-2022-email-to-association.html
