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: Source of Ascorbic Acid (Synthetic, Laboratory-Created Vitamin C)
Dear Dr. Califf:
During my hospitalization, I suffered a severe hypoglycemic episode due to the fact that I have an IgE-mediated allergy to corn; therefore, straight saline-only IV fluids were administered to me. I was then given orange juice to drink; however, this required an antihistamine to be injected through my IV, since the orange juice contained corn-derived ascorbic acid (synthetic, laboratory-created Vitamin C). My allergy to corn was clearly documented in my medical records; however, the hospital staff still gave me orange juice which contained my allergen (corn). Why did my attending clinicians not know that ascorbic acid is synthetic Vitamin C that is usually derived from corn? If I was anaphylactic to corn, this oversight could have proven fatal to me.
In an effort to protect the lives of corn-allergic citizens, I would recommend that the FDA correct the following Food Additive Status List reference. In addition, it is of critical importance that the source of the synthetic Vitamin C be clearly indicated within the FDA's Codes of Federal Regulation.
From: Vitamin C - See Ascorbic Acid
To: Vitamin C - See Ascorbic Acid (synthetic Vitamin C)
Documentation:
1. Code of Federal Regulation 21CFR182.3013
Subpart D - Chemical Preservatives [emphasis added]
Sec. 182.3013 Ascorbic acid.
(a) Product. Ascorbic acid.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.3013
2. Name of Material: "Ascorbic Acid"
Is this substance Natural or Synthetic? Explain (if appropriate)
"Synthetic compound because of its extraction and purification using synthetic acidulants."
https://www.ams.usda.gov/sites/default/files/media/Ascorbic%20Acid%20TR.pdf
3. Code of Federal Regulation 21CFR184.8013
"Subpart 1 - Nutrients [emphasis added]
Sec. 182.8013 Ascorbic acid.
(a) Product. Ascorbic acid."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.8013
4. All About Where Vitamin Supplements Come From, By Ryan Andrews, MS, MA, RD, RYT, CSCS
"When a vitamin is marked “natural”, it only has to include 10% of actual natural plant-derived ingredients. The other 90% could be synthetic.
Most vitamin C currently manufactured is synthetic, coming from China. Vitamin C is a weak acid. Many supplements use salt forms (sodium ascorbate, calcium ascorbate, magnesium ascorbate) to decrease acidity.
The most popular form of synthetic vitamin C is ascorbic acid. [emphasis added] Naturally occurring vitamin C is the same molecule as synthetic ascorbic acid. But in food, ascorbic acid is found within the vitamin C complex among other compounds. The ascorbic acid in supplements is often derived from corn starch, corn sugar, or rice starch, and is chemically dependent upon volatile acids." [emphasis added]
https://www.precisionnutrition.com/all-about-vitamin-supplements?fbclid=IwAR2LLGs6-KnEfVL-7vqcSQrnIs1987pz-CtePo5B57qLJP66gqaG3N1Yhzs
5. "According to an article in The Healthy Home Economist, ascorbic acid is actually synthetic vitamin C, usually derived from GMO corn. [emphasis added] And, there is a growing body of evidence that those consuming high doses of ascorbic acid should have reason to worry."
https://www.northcoast.organic/beware-ascorbic-acid-synthetic-vitamin-c/?
6. "Over 90% of ascorbic acid in this country is manufactured at a facility in Nutley, New Jersey, owned by Hoffman-LaRoche, one of the world’s biggest drug manufacturers (1 800 526 0189). Here ascorbic acid is made from a process involving cornstarch and volatile acids. [emphasis acid] Most U.S. vitamin companies then buy the bulk ascorbic acid from this single facility. After that, marketing takes over. Each company makes its own labels, its own claims, and its own formulations, each one claiming to have the superior form of vitamin C, even though it all came from the same place, and it’s really not vitamin C at all."
https://www.justlivewell.com/whole-food-vitamins-ascorbic-acid-is-not-vitamin-c/
Dr. Califf, since my acute hypoglycemic episode caused delirium, I was unable to alert the attending clinicians that they must first verify the source of each and every ingredient in any juice and/or food product with the manufacturer to verify the presence of corn-derived ingredients due to the fact that corn is exempt from FDA labeling requirements.
This is a common complaint by the 17K+ members in our corn allergy support groups (more than double the membership in sesame seed allergy support groups). We would like an explanation as to why we are frequently offered foods, fluids, and drug/biologic products containing corn-derived ingredients when our IgE-mediated allergy to corn is clearly documented in our medical records.
On behalf of corn-allergic citizens, we would appreciate your reply to this critical concern. Corn-allergic patients should not be required to educate our clinicians that ascorbic acid is synthetic Vitamin C that is usually derived from corn (our allergen).
Sincerely,
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email: cornallergyiniitiative@gmail.com
Twitter: @CornAllergy911
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