I have been conducting oral challenges of products advertised as
"corn free" by the manufacturer. If I experience a corn
allergy reaction, I then file reports with the manufacturer, the FDA, and the
FTC.
WARNING:
I strongly recommend that you do not attempt any oral food
challenges unless you are in the presence of your physician. Although I
have not yet experienced an anaphylactic reaction to corn or my other
allergens, I did have epinephrine auto-injector pens available (prescribed for
my allergy to most antibiotics).
September 22, 2018 through September 28, 20181
Oral challenges of Windmill® Calcium Citrate Dietary Supplement,
100 Tablets
UPC Code 035046001551
Lot #0314C8
Exp. Date: 03/21
Directions: Take 2 tablets once or twice daily as a dietary supplement
or as directed by a healthcare professional.
Label states that this product is free of “sugar, yeast, corn,
milk, soy, artificial colors, flavors or preservatives.”
I have been taking this dietary supplement as directed on the
label since September 22, 2018, based on a recommendation by my primary care
physician that I consume more calcium. I
have physician-diagnosed allergies to corn, yeast, soy, dairy, etc.; and have
not experienced any allergic reaction to this product. Therefore, I have deemed this product “safe
for me.” However, please trial with caution in the event they change
their formulation or if ingredients are compromised due to
cross-contamination.
In the event you experience a corn allergy reaction to a product
that is labeled "corn free," refer to instructions for filing reports
in the following links:
Non-FDA-Compliant "Corn-Free" Claims (Revised
11/16/17); Title 21 U.S.C. - Section 343, Chapter 1 - Adulterated or Misbranded
Foods or Drugs
FTC Filing a Complaint to Report False and Misleading Labeling
FDA Warning Letter to
Windmill Health Products, LLC, October 7, 2014
“The
United States Food and Drug Administration (FDA) conducted an inspection of
your firm, Windmill Health Products, LLC, located at 6 Henderson Drive, West
Caldwell, NJ, from June 18 through July 17, 2013. The inspection revealed
serious violations of the Current Good Manufacturing Practice (CGMP)
regulations for Manufacturing, Packaging, Labeling, or Holding Operations for
Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR
111). These violations cause your dietary supplement products to be adulterated
within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic
Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)] in that the products
have been prepared, packed, or held under conditions that do not meet CGMP
requirements for dietary supplements. Our investigator's observations were
noted on form FDA-483, lnspectional Observations, which was issued on July 17,
2013.”
Diane H., Corn Allergy Advocate
