Curex and the FDA: the complete correspondence
Every letter the FDA has sent Curex, every response Curex has sent back, and the documents themselves — including the one where the regulator said the first fix was incomplete.
Curex has received three letters from the FDA and has answered each in writing. One, from 2021, concerns the allergy drops and says what this site says elsewhere: customized sublingual drops are not an FDA-approved product. Two, from 2025 and 2026, concern marketing of a separate compounded GLP-1 program; the second of those found Curex’s first response only partially adequate, and Curex responded with a site-wide remediation. None is a recall, a safety finding or a lawsuit. All six documents are below.
Medically reviewed by Dr. Chet Tharpe, M.D. · Last reviewed September 2026
Why this page exists
The whole exchange, not the easy half
Two of these letters are public on fda.gov, and a search for Curex will surface them. Rather than leave a reader to find a letter without its response — or the September 2025 response without the letter that called it incomplete — the whole exchange is here: every letter the FDA has sent, every response Curex made, the PDFs, and the wording the FDA used.
Two product lines are involved and the distinction matters. The 2021 letter is about the allergy drops. The 2025 and 2026 letters are about the compounded GLP-1 weight-loss program and make no finding about allergy care. Cards about the allergy drops are marked in pink below.
At a glance
The record in numbers
- letters from the FDA (2021, 2025, 2026)
- 3letters from the FDA (2021, 2025, 2026)
- written responses from Curex, published here
- 3written responses from Curex, published here
- FDA letters that concern the allergy drops
- 1 of 3FDA letters that concern the allergy drops
- recalls, seizures, injunctions or patient-harm findings
- 0recalls, seizures, injunctions or patient-harm findings
The documents
In order, with what each one said
Letters from the agency are shown on white; Curex’s responses on grey. Each card links to the document itself — our hosted PDF and, where the FDA publishes the letter, the copy on fda.gov.
- March 23, 2021From FDAUntitled letterAbout the allergy drops
Marketing of unapproved allergenic extract mixtures
FDA’s biologics center reviewed getcurex.com and objected to how the allergy drops were marketed. It quoted statements such as “Curex allergy drops (also known as sublingual immunotherapy) is an equally effective, much less invasive way to treat allergies from home” and “We use FDA-approved extracts in a clinically proven practice”.
The agency’s position: a customized mixture of allergenic extracts is a drug and a biological product, and a mixture of licensed extracts may only be marketed under an approved biologics license application (BLA). Curex had neither a BLA nor an investigational new drug application in effect, so marketing the mixtures “appears to violate the FD&C Act and the PHS Act”. The letter also noted that biological products are not eligible for the compounding exemptions in sections 503A and 503B.
This is the only FDA communication in the record that concerns the allergy drops. It is the regulatory expression of the fact stated throughout this site: customized multi-allergen sublingual drops are not an FDA-approved product and are prescribed off-label. The same position applies to every US provider of customized sublingual drops.
An untitled letter is FDA’s lower-tier communication, used for violations that do not meet the threshold for a warning letter. A written response was requested within 30 days.
“Your products are not the subject of an approved BLA nor is there an IND in effect for any of your products. Therefore, the marketing and distribution of such products appears to violate the FD&C Act and the PHS Act.”
Signed: Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research.
- What it was not
- Not a recall, seizure, injunction, or any finding of patient harm. Not a restriction on the service.
- Where it stands
- Answered on April 22, 2021. FDA does not routinely publish close-out letters for untitled letters; there has been no further FDA correspondence about the allergy product.
- April 22, 2021From CurexResponseAbout the allergy drops
Response to the March 23, 2021 letter
Curex responded through outside regulatory counsel within the 30-day window. The response states that Curex “has removed the statements identified in your letter and other similar statements promoting unlicensed products”.
The website was rewritten as “help-seeking” material: it describes allergies and allergy therapy generally and directs the reader to a clinician to discuss appropriate treatment, rather than promoting a specific unlicensed product. The response describes Curex as a telehealth platform giving patients access to licensed allergy clinicians.
FDA does not routinely publish close-out letters for untitled letters, and there is no further correspondence on the allergy product in the record. Curex has operated continuously since.
“Curex has removed the statements identified in your letter and other similar statements promoting unlicensed products.”
Signed: David L. Rosen, BS Pharm., JD, Foley & Lardner LLP, on behalf of Curex, Inc..
- What it was not
- Not a dispute of FDA’s position. Not a change to the treatment itself, which remains off-label.
- Where it stands
- No further correspondence on the allergy product in the record.
- September 9, 2025From FDAWarning letterNot about allergy
Misleading claims about compounded semaglutide and tirzepatide
FDA reviewed getcurex.com in August 2025 and found that claims about compounded GLP-1 weight-loss medications were false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The claims quoted were “Clinically proven success”, “Clinically proven weight loss treatments”, “The same active ingredients as Ozempic or Mounjaro”, “Prescription weight loss with the same active ingredients as Mounjaro & Zepbound”, and “While we don’t prescribe Ozempic, Wegovy, Zepbound, or Mounjaro directly, we may prescribe treatments containing the same active ingredients”.
The objection was that this wording implies a compounded preparation is the same as, or equivalent to, an FDA-approved drug. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety, effectiveness or quality.
The letter was part of a September 2025 enforcement wave in which FDA sent roughly 80 warning letters and 40 untitled letters to telehealth companies and compounders over GLP-1 marketing. It concerns a separate product line: it made no finding about sublingual immunotherapy, allergy drops or allergen extracts, and it is not a recall, a medication-safety finding or a lawsuit. A written response was required within 15 working days.
Signed: George Tidmarsh, M.D., Ph.D., Center for Drug Evaluation and Research (warning letter MARCS-CMS 716821).
- What it was not
- Not about allergy care. Not a recall, not a safety finding about any medication, not a lawsuit.
- Where it stands
- Answered on September 30, 2025 — a response FDA later found only partially adequate.
- September 30, 2025From CurexResponseNot about allergy
Response to the September 9, 2025 warning letter
Curex answered within the deadline. The response reports that every phrase quoted in the warning letter, “and any variants conveying the same message”, was removed from the site, and that comparative “same active ingredient” messaging and language implying equivalence to FDA-approved drugs was taken out. Exhibit A lists each edit, old wording against new.
It also describes new process: a Regulatory Pre-Publication Checklist for any web copy about compounded medications, a two-person Medical plus Regulatory/Compliance approval step for such content, staff training on FDA advertising rules for compounded drugs, and a change log recording each edit with URL, timestamp and approver.
This response turned out to be incomplete. FDA said so in May 2026 (next document), and Curex’s June 2026 response accepts the finding. Both are below.
Signed: Gene Kakaulin, CEO, Curex, Inc..
- What it was not
- Not the end of the matter. This response was incomplete, and FDA said so eight months later.
- Where it stands
- Found “partially adequate” by FDA on May 27, 2026.
- May 27, 2026From FDAFollow-up letterNot about allergy
The September 2025 response was “partially adequate”
FDA reviewed the site again in April 2026 and found that the September 2025 response “addresses some of FDA’s concerns” but had shortcomings that “preclude finding the response fully adequate”. This letter is not, as of this writing, published on fda.gov. We publish it here because a record that stopped at the previous document would be misleading.
Three findings. First, the response leaned on disclaimers: statements such as “Compounded medications have not been approved by the FDA” were added, but FDA’s position is that such statements “do not, in this context, mitigate the misleading impression” created by a comparative claim. Second, comparative claims were still on the site, including “Compounded Tirzepatide (same active ingredient as Mounjaro®*)” and “Curex offers the same active ingredient as Mounjaro”. Third, product images showed “Curex” on the label, suggesting Curex was the compounder when it is not.
The letter also states that FDA “has received complaints regarding your promotional materials for compounded drug products disseminated across multiple platforms”, that the agency “is generally aware of adverse event reports associated with compounded drug products” as a category, and that its evaluation of Curex “remains ongoing and is not limited to your website”. It required Curex to reassess all promotional material, including social media, within 15 working days, and to supply the names of the pharmacies that compound the products and representative labeling. Failure to address violations “may result in legal action without further notice, including, without limitation, seizure and injunction”.
Like the 2025 warning letter, this concerns the compounded GLP-1 program only. It makes no finding about the allergy service.
“Your response is partially adequate. Your response addresses some of FDA’s concerns.”
“Such statements do not, in this context, mitigate the misleading impression.”
“FDA’s evaluation of your operation remains ongoing and is not limited to your website.”
Signed: Matthew J. Lash, Acting Director, Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research.
- What it was not
- Not about allergy care. Not a recall, not a safety finding about a Curex product, not a lawsuit — though it warns one is possible if violations are not corrected.
- Where it stands
- Answered on June 22, 2026.
- June 22, 2026From CurexResponseNot about allergy
Response to the May 27, 2026 letter
Curex accepted FDA’s findings and treated them “as a directive to conduct a comprehensive, site-wide reassessment rather than to address only the specific examples cited”. The re-audit found the gap: several residual claims lived in page metadata — titles, meta descriptions and Open Graph tags that appear in search results and social previews — which the September 2025 clean-up had not covered. Paid search, social advertising and email/SMS templates were reviewed as well.
Corrections listed with a page-level log: the “same active ingredient as Mounjaro/Zepbound” constructions removed from product-page titles and copy; “more effective” superiority framing removed; “weight loss” promotional framing replaced with neutral “GLP-1” and “compounded semaglutide or tirzepatide” descriptors; all metadata updated; the legacy /weightloss/ URL path retired; product imagery changed so labels identify the compounding pharmacy rather than Curex. On disclaimers, the response says the approach is now “to remove the misleading claims themselves rather than to rely on added disclaimer text”.
Process changes: pre-publication review now expressly covers metadata; the checklist was re-issued with an explicit prohibition on sameness, equivalence, interchangeability and comparative-efficacy claims; and a recurring monthly review of every GLP-1 and compounded-medication page, content and metadata, is recorded in a change log.
As FDA requested, the response names the state-licensed 503A pharmacies that compound the products — Innovation Compounding Pharmacy, LLC; Boothwyn Pharmacy, LLC; RPC2B, LLC; and Vios Compounding Pharmacy — and attaches representative labels (Exhibit A) showing the pharmacy, not Curex, as the compounder.
“We note FDA’s point that disclaimers do not cure an otherwise misleading comparative claim. Accordingly, our approach has been to remove the misleading claims themselves rather than to rely on added disclaimer text to contextualize them.”
Signed: Gene Kakaulin, CEO, Curex, Inc..
- What it was not
- Not a close-out. FDA has not issued one, and its May letter described the evaluation as ongoing.
- Where it stands
- As of September 21, 2026, the June 22, 2026 response is the most recent document in the record. FDA has not issued a close-out letter for either matter; its May 2026 letter described the GLP-1 evaluation as ongoing. This page will be updated when there is further correspondence, in either direction.
Status
Where it stands
As of September 21, 2026, the June 22, 2026 response is the most recent document in the record. FDA has not issued a close-out letter for either matter; its May 2026 letter described the GLP-1 evaluation as ongoing. This page will be updated when there is further correspondence, in either direction.
For patients
What this means if you are considering allergy treatment
The only letter about the allergy drops is the 2021 one, and what it says is what this site says elsewhere: customized sublingual drops are not an FDA-approved product and are prescribed off-label, under the same regulatory position as every other US provider of customized drops. The evidence for the treatment itself, and its limits, are on the evidence and guidelines page.
The GLP-1 letters do not bear on the allergy service. They do show how the company handles a regulator: the first fix was incomplete, the FDA said so, and the second fix went wider than what was cited. Readers can weigh that however they see fit; the documents are here so that they can.
❓Frequently Asked Questions
Three: an untitled letter dated March 23, 2021 from the Center for Biologics Evaluation and Research about the allergy drops; a warning letter dated September 9, 2025 from the Center for Drug Evaluation and Research about compounded GLP-1 marketing; and a follow-up letter dated May 27, 2026 from the same office finding the 2025 response partially adequate. Curex responded in writing to each, on April 22, 2021, September 30, 2025 and June 22, 2026. All six documents are on this page.
Only the March 23, 2021 untitled letter. FDA’s biologics center took the position that a customized mixture of allergenic extracts is a biological product that would need an approved biologics license to be marketed, and that Curex had neither a license nor an investigational application. That is the regulatory form of a fact stated across this site: customized multi-allergen sublingual drops are not an FDA-approved product and are prescribed off-label, by every US provider of them. Curex’s response removed the cited claims and rewrote the site as general, help-seeking material. The 2025 and 2026 letters concern the compounded GLP-1 program and made no finding about the allergy service.
In its May 27, 2026 letter FDA said the September 2025 response was “partially adequate”. An April 2026 review of the website still found comparative claims — “Compounded Tirzepatide (same active ingredient as Mounjaro®*)” and “Curex offers the same active ingredient as Mounjaro” — and product images with “Curex” on the label, suggesting Curex was the compounder when it is not. FDA also rejected the approach of adding disclaimers: statements that compounded drugs are not FDA-approved “do not, in this context, mitigate the misleading impression” created by a comparative claim. The letter noted complaints received about Curex’s promotional materials, said the agency’s evaluation was ongoing and not limited to the website, and warned that failure to address violations could result in legal action including seizure and injunction.
A site-wide re-audit found that most residual claims sat in page metadata — titles, meta descriptions and Open Graph tags that surface in search results and social previews — which the September 2025 clean-up had not covered. Curex removed the “same active ingredient” constructions from product-page titles and copy, removed “more effective” framing, replaced “weight loss” promotional wording with neutral GLP-1 descriptors, updated all metadata, retired the legacy /weightloss/ URL path, changed product imagery so labels identify the compounding pharmacy, and reviewed paid search, social ads and email/SMS templates. It named the four state-licensed 503A pharmacies that compound the products — Innovation Compounding Pharmacy, Boothwyn Pharmacy, RPC2B and Vios Compounding Pharmacy — and instituted a monthly review of every GLP-1 page with a change log. The response states the approach is now to remove misleading claims rather than to contextualize them with disclaimers.
Because the alternative is a record that stops at the September 2025 response and implies the matter was closed, which is not what happened. The 2021 and 2025 letters are already public on fda.gov; anyone researching Curex will find them. Publishing the May 2026 letter and the June 2026 response alongside them lets a reader see the whole exchange, including the part where the regulator said the first fix was incomplete, and judge for themselves how it was handled.
No. All three letters concern how products were described in marketing. None is a recall, a seizure, an injunction, a finding of patient harm or a lawsuit. The May 2026 letter does state that FDA is “generally aware of adverse event reports associated with compounded drug products” — a statement about compounded drugs as a category, not a finding about a Curex product — and that failure to correct violations could lead to legal action. That is the standard language of FDA compliance correspondence, and it is reproduced here rather than omitted.
As of September 21, 2026, the June 22, 2026 response is the most recent document in the record. FDA has not issued a close-out letter for either matter; its May 2026 letter described the GLP-1 evaluation as ongoing. This page will be updated when there is further correspondence, in either direction.
Record current as of September 21, 2026. Documents are added when correspondence is sent or received, in either direction, and the status section is updated at the same time.
This content is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider with questions about a medical condition. Content reviewed by board-certified allergists at Curex.
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