Introduction

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Curex. The letter—published by FDA’s Center for Drug Evaluation and Research (CDER)—focuses on misbranding claims related to the promotion of compounded semaglutide and tirzepatide products on Curex’s website. It is not an enforcement action about allergy drops per se, but it is an FDA notice requiring corrective action within 15 working days.

What FDA cited (and what it didn’t)

Issuing office and date: CDER Warning Letter dated September 9, 2025.
Core findings: FDA states Curex’s claims about compounded semaglutide and tirzepatide (e.g., implying sameness to branded, FDA‑approved products) are false or misleading; FDA classifies these compounded drugs as misbranded.
Required response: Curex is instructed to address violations within 15 working days or face potential further action (e.g., seizure or injunction).
Not about SLIT drops: This 2025 letter does not adjudicate on allergy drops; it addresses misbranding of compounded GLP‑1 products on Curex’s website.

Related 2021 FDA action (background)

In March 2021, CBER listed an Untitled Letter to Curex regarding allergen products; third‑party coverage at the time summarized FDA’s concerns about promotion of sublingual allergy drops without required approvals. Untitled Letters are advisory and precede (and are distinct from) Warning Letters.

Plain‑English summary for patients

What happened: FDA formally warned Curex (9/9/2025) that its marketing claims for compounded weight‑loss drugs (semaglutide/tirzepatide) were misleading and therefore “misbranded.” FDA asked for fixes within 15 business days. This letter does not directly decide the safety or effectiveness of Curex’s allergy drops.
Why this matters: When any telehealth company receives FDA enforcement correspondence, it’s a signal to check how that company markets, sources, and oversees medicines—especially compounded or customized therapies.
The SLIT landscape: In the U.S., only specific sublingual immunotherapy (SLIT) tablets (for defined allergens) are FDA‑approved; custom multi‑allergen SLIT “drops” are not FDA‑approved and are typically used off‑label under physician supervision. Patients should understand this regulatory distinction.

Key excerpts distilled from the FDA letter (interpreted)

“Compounded drug products are not FDA‑approved… Your claims imply that your products are the same as an FDA‑approved product when they are not.” (FDA characterization of misbranding risk.)
“Failure to adequately address any violations may result in legal action… including seizure and injunction.” (Potential consequences).

Patient checklist: how to vet a telehealth allergy provider

Use this quick screen before starting care with any at‑home allergy service:

Physician leadership and access
Is care overseen by U.S.‑licensed, board‑certified physicians? Can you reach a clinician 1:1 (not only chatbots or sales reps)?
Transparency on labeling and approvals
Do they clearly distinguish FDA‑approved SLIT tablets (limited allergens) from off‑label custom SLIT drops? Are promotion claims careful not to imply equivalence to FDA‑approved products?
Allergen extracts and sourcing
Are allergen extracts obtained from licensed U.S. manufacturers? Do they provide documentation on potency, sterility, and handling consistent with applicable standards?
Compounding and quality systems
If any products are compounded, is compounding performed by an appropriate pharmacy, with quality control (sterility, potency, stability) and a clear chain of custody? (FDA regularly inspects compounding firms; enforcement histories are public.)
Claims discipline
Are marketing claims strictly evidence‑based and compliant (no “same as FDA‑approved” language for unapproved products; no overstated efficacy)?
Outcome tracking and safety
Do they specify expected timelines for improvement, common side effects, and escalation protocols? Is there an option to report adverse events and get timely medical follow‑up?

Where to read the source documents

FDA Warning Letter to Curex (CDER), September 9, 2025.
CBER list noting an Untitled Letter to Curex, March 23, 2021.
Background explainer that only SLIT tablets (not custom drops) are FDA‑approved in the U.S.

How Wyndly addresses safety, labeling, and results

If you’re evaluating allergy care, review these resources:

Safety & Results hub (regulatory posture, clinical evidence, and care model). See: Does Wyndly Work?
FDA/label and clinical‑guideline basics for SLIT vs. shots: Sublingual Immunotherapy (SLIT) at Wyndly

Quick table: the 2025 Curex letter at a glance

Item	Detail
Issuer	FDA/CDER
Letter type	Warning Letter
Date	September 9, 2025
Topic	Misbranding claims for compounded semaglutide/tirzepatide
What FDA asked for	Correct violations; respond within 15 working days
Applies to allergy drops?	Not directly; letter addresses GLP‑1 promotion on website

FAQs

Does the 2025 FDA letter ban allergy drops? No. The September 9, 2025 Warning Letter concerns website claims for compounded semaglutide and tirzepatide. It does not directly adjudicate allergy drops.

Are custom SLIT drops FDA‑approved in the U.S.? No. Only certain SLIT tablets are FDA‑approved; custom multi‑allergen SLIT drops are typically used off‑label under physician oversight.

Has FDA contacted Curex about allergy products before? CBER lists an Untitled Letter to Curex dated March 23, 2021. Untitled Letters are advisory and distinct from Warning Letters.

What should patients do now? If you’re a Curex patient using any compounded medication, review FDA’s letter, ask your provider how they’ve remediated, and consider the checklist above to ensure safe, compliant care.

What the FDA’s 2025 Warning Letter to Curex Means for Patients