Curex and the FDA
Two separate matters: FDA letters about compounded GLP-1 marketing in 2025–2026, which did not concern the allergy drops, and a 2021 untitled letter about marketing allergenic extracts. What each was about, what Curex changed, and the documents themselves.
The FDA’s September 9, 2025 warning letter to Curex concerns the marketing of compounded GLP-1 products (semaglutide and tirzepatide), not the allergy drops; the only FDA letter about the allergy service was an untitled letter — the FDA’s lower-tier communication — dated March 23, 2021, about the marketing of allergenic extracts. Curex answered the 2021 letter on April 22, 2021 and changed its website; it answered the 2025 warning letter on September 30, 2025, and when the FDA requested additional changes on May 27, 2026, Curex implemented them and responded on June 22, 2026. The September 2025 letter was one of roughly 80 warning letters and 40 untitled letters the FDA sent to telehealth companies and compounders that month; every letter and response is published below. Curex believes it is in compliance with the FDA and with state pharmacy and medical boards.
Medically reviewed by Dr. Neeta Ogden, MD, FACAAI · Last reviewed September 2026
1 · Allergy drops
FDA correspondence about marketing allergy drops
- In 2021 the FDA had questions about how Curex marketed sublingual allergy drops. Because the drops are personalized for each patient and prepared by a licensed pharmacy, they are not reviewed or approved by the FDA. The language on Curex’s website at the time did not fully explain this.
- Curex responded and changed the website. It now states clearly what Curex provides: information about allergies and access to doctors and a pharmacy. Patients can consult board-certified allergists and licensed clinicians, who may prescribe sublingual allergy drops. The drops are prepared by a licensed pharmacy, and the site makes clear they are not reviewed by the FDA.
- Curex has not heard from the FDA about allergy drops since its 2021 response.
Personalized allergy drops are compounded for each individual patient. Such formulations are not reviewed by the FDA. However, they remain common practice for allergists and ENT allergists because they provide a convenient alternative to allergy shots. Allergy drops are the standard of care in many EU countries.
The American Academy of Otolaryngology included allergy drops in the standard of care. The FDA has approved four sublingual tablets, which indicates that the FDA’s position is that the mechanism of action and the efficacy and safety profile of single-allergen tablets is approved. Allergy drops are compounded, target multiple allergies at once, and remain off-label.
More on what this means for treatment: why personalized allergy drops are prescribed off-label and the evidence behind sublingual immunotherapy.
- March 23, 2021From FDAUntitled letterAllergy drops
Questions about the marketing of sublingual allergy drops
FDA’s biologics center reviewed getcurex.com and raised questions about how the website described Curex’s sublingual allergy drops, including statements comparing them with allergy shots and references to FDA-approved extracts.
The drops are personalized for each patient: a licensed clinician prescribes them and a licensed pharmacy prepares each mixture from FDA-licensed allergen extracts. Personalized mixtures like these are not reviewed or approved by the FDA — true of every US provider of customized allergy drops — and the website language at the time did not explain that clearly.
An untitled letter is FDA’s lower-tier communication, used for matters that do not meet the threshold for a warning letter. A written response was requested within 30 days.
Signed: Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research.
- Where it stands
- Answered by Curex on April 22, 2021.
- April 22, 2021From CurexResponseAllergy drops
Response to the March 23, 2021 letter
Curex responded through regulatory counsel within the 30-day window. It removed the statements FDA identified and similar statements, and rewrote the website to explain what Curex provides: information about allergies and access to licensed clinicians and a licensed pharmacy.
The site now makes clear that allergy drops are prescribed by a clinician when appropriate, prepared by a licensed pharmacy, and not reviewed or approved by the FDA.
Curex has not received further correspondence from the FDA about allergy drops since this response.
“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..
- Where it stands
- No further FDA correspondence about allergy drops since.
2 · GLP-1 products
FDA letters to Curex about GLP-1 product marketing
- In September 2025 the FDA launched a broad campaign on direct-to-consumer drug advertising, the same day a presidential memorandum directed stricter enforcement. That month it sent roughly 80 warning letters and 40 untitled letters to telehealth companies and compounding pharmacies, most about compounded GLP-1 products, followed by further rounds in March 2026 (30 warning letters) and June 2026 (25). Many of the best-known companies in the category received letters.
- The letter to Curex concerned marketing language for compounded GLP-1 products. These products are prescribed by licensed clinicians and prepared by licensed pharmacies; because they are compounded, the FDA does not review them for safety or effectiveness. The FDA took issue with how Curex’s marketing described them.
- Curex changed the language and responded to the FDA in September 2025.
- In May 2026 the FDA requested additional changes. Curex implemented them and responded in June 2026.
Industry context: FDA: warning letters to 30 telehealth companies (March 2026) · Sheppard Mullin: the September 2025, March 2026 and June 2026 waves · Holland & Knight: the September 9, 2025 initiative.
- September 9, 2025From FDAWarning letterGLP-1 program
Marketing claims for compounded GLP-1 products
The letter concerned marketing language for compounded semaglutide and tirzepatide. FDA objected to wording — such as references to the same active ingredients as Ozempic or Mounjaro — that it read as implying Curex’s compounded products were equivalent to FDA-approved brand-name drugs.
Compounded GLP-1 products are prescribed by licensed clinicians and prepared by state-licensed pharmacies. Because they are compounded, the FDA does not review them for safety or effectiveness.
The letter was one of roughly 80 warning letters and 40 untitled letters FDA sent to telehealth companies and compounders that month, on the day a presidential memorandum directed stricter enforcement of prescription-drug advertising. It concerned marketing language only, and made no finding about Curex’s allergy service.
Signed: George Tidmarsh, M.D., Ph.D., Center for Drug Evaluation and Research (warning letter MARCS-CMS 716821).
- Where it stands
- Answered by Curex on September 30, 2025.
- September 30, 2025From CurexResponseGLP-1 program
Response to the September 9, 2025 warning letter
Curex responded within the deadline. The phrases FDA cited, and variants conveying the same message, were removed from the site, along with comparative “same active ingredient” messaging. Exhibit A lists each edit, old wording against new.
Curex also introduced a pre-publication checklist for any content about compounded medications, a two-person medical and compliance review, staff training on FDA advertising rules, and a change log of every edit.
Signed: Gene Kakaulin, CEO, Curex, Inc..
- Where it stands
- FDA requested additional changes on May 27, 2026.
- May 27, 2026From FDAFollow-up letterGLP-1 program
Request for additional changes
After a further review of the website, FDA acknowledged that the September 2025 response addressed some of its concerns and requested additional changes to the GLP-1 marketing, including remaining comparative wording and product images. It also asked Curex to identify the pharmacies that compound the products.
Signed: Matthew J. Lash, Acting Director, Office of Compounding Quality and Compliance, Center for Drug Evaluation and Research.
- Where it stands
- Answered by Curex on June 22, 2026, with the changes implemented.
- June 22, 2026From CurexResponseGLP-1 program
Response to the May 27, 2026 letter
Curex implemented the requested changes and went beyond the specific examples with a site-wide review, including page titles, search descriptions and social previews. Comparative wording was removed, the legacy /weightloss/ pages were retired, and product images now show the compounding pharmacy on the label.
Curex named the state-licensed 503A pharmacies that compound its GLP-1 products — Innovation Compounding Pharmacy, Boothwyn Pharmacy, RPC2B and Vios Compounding Pharmacy — and introduced a monthly review of every GLP-1 page, with a change log.
Signed: Gene Kakaulin, CEO, Curex, Inc..
- Where it stands
- Curex implemented the changes FDA requested and responded on June 22, 2026. As of September 29, 2026, that response is the most recent document. Any further correspondence will be added here.
Curex’s position
Where Curex stands
Curex believes it is in compliance with the FDA, the boards of pharmacy and medical boards in all 50 states, and other relevant regulators. It continues to improve its processes, disclaimers and information so that patients are well informed about everything it offers.
Curex responded in April 2021. There has been no further FDA correspondence about allergy drops since. Curex implemented the changes FDA requested and responded on June 22, 2026. As of September 29, 2026, that response is the most recent document. Any further correspondence will be added here.
For the wider picture — what Curex is and the evidence behind the treatment — see Is Curex legit?
❓Frequently Asked Questions
Two separate matters. In September 2025 the FDA’s drug center sent a warning letter about marketing language for compounded GLP-1 products — not the allergy drops — and in May 2026 requested additional changes; Curex responded in September 2025 and June 2026. In March 2021 the FDA’s biologics center sent an untitled letter about the marketing of allergenic extracts; Curex responded in April 2021. All of the documents are on this page.
In 2021 the FDA had questions about how the website described the drops. Allergy drops are personalized for each patient and prepared by a licensed pharmacy, so they are not reviewed or approved by the FDA, and the website language at the time did not fully explain this. Curex removed the statements the FDA identified and rewrote the site to make clear that Curex provides information and access to board-certified allergists, licensed clinicians and a licensed pharmacy, and that the drops are not FDA-reviewed. Curex has not heard from the FDA about allergy drops since.
Marketing language for compounded semaglutide and tirzepatide. These products are prescribed by licensed clinicians and prepared by state-licensed pharmacies; because they are compounded, the FDA does not review them for safety or effectiveness, and it objected to wording it read as implying equivalence to FDA-approved brand-name drugs. The September 2025 letter was part of an industry-wide campaign on direct-to-consumer drug advertising in which the FDA sent roughly 80 warning letters and 40 untitled letters to telehealth companies and compounders, followed by further rounds in March and June 2026.
In September 2025 Curex removed the cited phrases and similar wording, and introduced a pre-publication checklist, a two-person medical and compliance review, staff training and a change log. When the FDA requested additional changes in May 2026, Curex carried out a site-wide review that included page titles, search descriptions and social previews, retired the legacy /weightloss/ pages, changed product images to show the compounding pharmacy, named the four state-licensed 503A pharmacies that compound its GLP-1 products, and introduced a monthly review of every GLP-1 page.
No. The 2025 and 2026 letters concerned marketing of compounded GLP-1 products only and made no finding about sublingual immunotherapy, allergy drops or allergen extracts.
Curex responded in April 2021. There has been no further FDA correspondence about allergy drops since. Curex implemented the changes FDA requested and responded on June 22, 2026. As of September 29, 2026, that response is the most recent document. Any further correspondence will be added here. Curex believes it is in compliance with the FDA, the boards of pharmacy and medical boards in all 50 states, and other relevant regulators. It continues to improve its processes, disclaimers and information so that patients are well informed about everything it offers.
Record current as of September 29, 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.
Keep reading
- How Curex worksThe treatment process end to end, from at-home testing to daily drops.Read
- Curex reviewsWhat patients actually report — both clusters, including the complaints.Read
- Is Curex worth the money?Plan pricing against allergy-shot costs, and who Curex is worth it for.Read
- Evidence & guidelinesThe AAO guideline, the four FDA-approved tablets, the trial evidence and the 2,897-patient study.Read
- Providers comparedCurex, Wyndly, Nectar, Aspire, Allergychoices and United Allergy Services on offering, price, testing, studies and reviews.Read
- Drops vs shotsThe trial evidence, costs with and without insurance, the visit burden, and who each route fits — including when shots are the better choice.Read