Letter to FDA sent

[gothchiq]

I've finally got it all compiled and sent out. Here is the letter and list of sources:

January 4, 2021

Food and Drug Administration

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

To all whom it may concern:

More and more prescriptions, personal care products, cleansers, and other medical products are manufactured with propylene or polyethylene glycol, or other glycols. This is an increasing problem as at least 6% of the population is now shown to have a glycol allergy. Because glycol-free medicines are usually unavailable, we cannot take the medications our doctors prescribe for us, putting our health and our lives in grave danger. Most of us cannot afford to go to a compounding pharmacy, as insurance will not pay. Some of the affected people experience anaphylaxis upon the slightest exposure. Others "merely" have a skin rash with hives and painful redness similar to a chemical burn. Yet, for some reason, the FDA still has these glycols on the Generally Recognized As Safe list, and in many instances, product labels are not required to disclose glycol ingredients, so that no amount of due diligence protects us.

It has also come to my attention that the two approved vaccines against COVID-19 both contain polyethylene glycol, which leaves people with glycol allergies no recourse against this pandemic. The severity of this issue cannot be overstated.

Thousands of Americans' health is at risk from the inclusion of glycols into almost all medication and personal care products. Even in the hospital or on an ambulance we are not safe and may lose our lives from exposure to these substances. Many healthcare practitioners are unaware of the risk and of our lack of access to safe medications. This situation must be rectified as quickly as possible.

Enclosed is authoritative evidence proving that glycols are dangerous to a considerable portion of the population and should be taken off of the GRAS list.

Thank you for your attention to this matter.

Regards,

(redacted)

GLYCLOL ALLERGY ARTICLES

PRACTICE PEARLS| VOLUME 6, ISSUE 6, P2173, NOVEMBER 01, 2018

Polyethylene Glycol: Not Just a Harmless Excipient

Lucinda Kennard, MD, Krzysztof Rutkowski, MD, Rita Mirakian, MD, Annette Wagner, MD

Published: October 03, 2018 DOI:doi.org/10.1016/j.jaip.2018...

jaci-inpractice.org/article...

The Journal of Allergy and Clinical Immunology: In Practice Vol. 7 Issue 7. Polyethylene glycols and polysorbates: Two still neglected ingredients causing true IgE-mediated reactions. Gianfranco Calogiuri, MD, PhD, Caterina Foti, MD, Eustachio Nettis, MD, Elisabetta Di Leo, MD, PhD, Luigi Macchia, MD, Angelo Vacca, MD. DOI: doi.org/10.1016/j.jaip.2019... jaci-inpractice.org/article...

The Journal of Allergy and Clinical Immunology: In Practice. Vol. 7. Issue 6. Polyethylene Glycol Is a Cause of IgE-Mediated Anaphylaxis. Pedro Giavina-Bianchi, MD, PhD, Jorge Kalil, MD, PhD. DOI: doi.org/10.1016/j.jaip.2019... jaci-inpractice.org/article...

The Journal of Allergy and Clinical Immunology: In Practice. Vol. 8, Issue 4. Anaphylaxis to PEGylated liposomal echocardiogram contrast in a patient with IgE-mediated macrogol allergy. Matthew S. Krantz, MD, Yiwei Liu, PhD, Elizabeth J. Phillips, MD, Cosby A. Stone Jr., MD, MPH. Published: January 16, 2020 DOI: doi.org/10.1016/j.jaip.2019... jaci-inpractice.org/article...

The Journal of Allergy and Clinical Immunology: In Practice. Vol. 2 Issue 3. Macrogol hypersensitivity reactions during cleansing preparation for colon endoscopy. Stefano Pizzimenti, MD, Enrico Heffler, MD, Elena Gentilcore, MD, Claudia Bussolino, MD, Franco Nebiolo, MD, Giovanni Rolla, MD. Published:March 31, 2014. DOI: doi.org/10.1016/j.jaip.2014... jaci-inpractice.org/article...

The Journal of Allergy and Clinical Immunology: In Practice. VOLUME 7, ISSUE 5, P1533-1540.E8, MAY 01, 2019. Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized. Cosby A. Stone Jr., MD, MPH, Yiwei Liu, PhD, Mary V. Relling, PharmD, Andrew Abreo, MD, Jonathan A. Hemler, MD, Elizabeth J. Phillips, MD. Published: December 14, 2018. DOI: doi.org/10.1016/j.jaip.2018... jaci-inpractice.org/article...

Jover Cerdá, V., Rodríguez Pacheco, R., Doménech Witek, J. et al. Immediate hypersensitivity to polyethylene glycols in unrelated products: when standardization in the nomenclature of the components of drugs, cosmetics, and food becomes necessary. Allergy Asthma Clin Immunol 15, 9 (2019). doi.org/10.1186/s13223-019-... aacijournal.biomedcentral.c...

Wylon, K., Dölle, S. & Worm, M. Polyethylene glycol as a cause of anaphylaxis. Allergy Asthma Clin Immunol 12, 67 (2016). doi.org/10.1186/s13223-016-... aacijournal.biomedcentral.c...

Polyethylene Glycol Allergy Implicated in Lubricant Intolerance. Leroy, Kyley DO; Farrell, Ronan MD; Kerner, Caroline MD, MSC. American Journal of Gastroenterology: October 2017 - Volume 112 - Issue - p S974. journals.lww.com/ajg/Fullte...

Physician's Weekly. Hypersensitivity to Polyethylene Glycols & Polysorbates. Posted by Rebecca Rice | Dec 30, 2019. physiciansweekly.com/hypers...

And the Allergen Winner Is: Propylene Glycol! Jeannette Y. Wick, RPh, MBA, FASCP. Published Online: Friday, January 19th, 2018. contemporaryclinic.pharmacy...

Contact Allergy to Propylene Glycol and Cross-Reactions. Scheman, Andrew MD; Roszko, Karolina BS. Dermatitis: 11/12 2018 - Volume 29 - Issue 6 - p 350-351. doi: 10.1097/DER.0000000000000416 journals.lww.com/dermatitis...

Dermatologist. Focus on Propylene Glycol. Volume 21 - Issue 8 - August 2013. the-dermatologist.com/conte...

Three cases of anaphylaxis following injection of a depot corticosteroid with evidence of IgE sensitization to macrogols rather than the active steroid. Clinical and Translational Allergy, 2017; 7: 2 ncbi.nlm.nih.gov/pmc/articl...

Poly(ethylene glycol) in Drug Delivery: Pros and Cons as Well as Potential Alternatives. Angewandte Chemie, International Edition, Vol 49, Issue 36. onlinelibrary.wiley.com/doi...

Allergy to Macrogols (Polyethylene Glycol). From Ask the Expert: American Academy of Allergy Asthma & Immunology, 3/6/2013. aaaai.org/ask-the-expert/pr...

Anaphylaxis following a transvaginal ultrasound. From Allergy Asthma and Clinical Immunology 12(1) · December 2016. researchgate.net/publicatio...

Two cases of anaphylaxis to macrogol 6000 after ingestion of drug tablets. Allergy: European Journal of Allergy and Clinical Immunology Volume 61, Issue 8, August 2006. onlinelibrary.wiley.com/doi...

Propylene Glycol: An Often Unrecognized Cause of Allergic Contact Dermatitis in Patients Using Topical Corticosteroids. Skin Therapy Letter, Volume 16 Number 5, May 1, 2011. skintherapyletter.com/aller...

Clin Exp Allergy. 2016 Jul;46(7):907-22. doi: 10.1111/cea.12760. Immediate-type hypersensitivity to polyethylene glycols: a review. Wenande E1, Garvey LH1. ncbi.nlm.nih.gov/pubmed/271...

[missleb1281]

Thank you for doing this! I will write a letter as well. The more people that speak up the better.

[gothchiq in reply to missleb1281]

Please do! I forgot to mention, the source for knowing there's PEG in the vaccines is ConsumerLab, an independent testing site.

[Lynne0762 in reply to gothchiq]

I called a pharmacist at the FDA and she told me PEG was in both vaccines and polysorbate 80 is in J&J. I've read effects were similiar...I don't recall the words. Check it out for yourself.....

[gothchiq in reply to Lynne0762]

Thus far I have not reacted to polysorbates. Let's hope that lasts, lol.

[Jacquie7]

Thank You for doing this!

[findtheanswernow]

This is great. Well written, to the point. A resource for many. And some day... it will bring about change.

[sickofitt]

I thought I was the only one allergic to this additive. Thank you for doing this.

[Shiloh1]

I just joined this site. I too am highly allergic to PEG, with all the attendant problems it causes. Listen, send your letter, but don’t expect much action. I have been trying for years. That said, I finally got a team behind my effort with resources and contacts to make people listen - childrenshealthdefense.org. They have amplified my message. They have done additional research and published my letters and theirs on their Defender health news publication. They have gotten me on radio shows to tell my story. I would love to share your letter with my contacts at Childrens Health Defense and your contact information. We continue to build momentum on this issue, and others. They have their lawyers looking into the best way forward to get a reclassification of PEG. They are also looking into how they might stop an emergency rollout to Georgia and Tennessee of a virucide to be spread through building and public transportation HVAC systems which uses triethylene glycol as the active ingredient. I have finally gotten my congressman’s office engaged with the FDA on the need for reclassification. Here is my contact info: LtCol Harold R. Gielow USMC (ret), [e-mail], 434-917-1519. You can google my name and childrens health defense and see some of our articles on this subject. Great to find more like myself who are not going to sit idle and do nothing when they know this condition affects so many people in a big way. Thanks!

[gothchiq in reply to Shiloh1]

The more ppl who make noise, the better chance we have to make a difference. I sent a letter to the EPA about that same thing. People could die by inhaling it! I responded to ur message.