A Warning to the Beauty Industry! FDA Issues Warning to Unapproved Botox Sales Sites: The Safety Standards of "Online Beauty Medicine" Under Scrutiny

A Warning to the Beauty Industry! FDA Issues Warning to Unapproved Botox Sales Sites: The Safety Standards of "Online Beauty Medicine" Under Scrutiny

2025年11月07日 00:32

"Cheaper than clinics" and "Easy through personal import"—such claims have spread the concept of "online injections (DIY tox)," which the U.S. Food and Drug Administration (FDA) has decisively halted. On November 5, 2025 (U.S. time), the FDA sent warning letters to 18 websites selling counterfeit or unapproved botulinum toxin products (commonly known as Botox-like products). This action was taken following reports of adverse events and botulinum symptoms, and was widely reported by various media via the U.S. AP【U.S. Food and Drug Administration】.


What Happened: Details of the Simultaneous Warning to 18 Sites

In the FDA's announcement, domains such as acecosm.com, maypharm.net, koreanfiller.com, glamderma.com, meamoshop.com, and mjsmedicals.com were specifically listed among 18 domains. The illegal sale of **"unapproved, misbranded, and prescription drugs"** was highlighted as a concern, with the seriousness of potential botulinum symptoms (such as swallowing and breathing difficulties, muscle weakness) being repeatedly emphasized【U.S. Food and Drug Administration】.


The actual warning letters also exemplified specific unapproved products in the U.S., such as Innotox and Wondertox【U.S. Food and Drug Administration】.

The FDA clearly recommended that "injections should be performed by licensed healthcare professionals using approved products from legitimate distribution channels." They urged immediate medical consultation if symptoms appear【U.S. Food and Drug Administration】.


Background: Why "Unapproved" is Dangerous

  • Variations and Counterfeits in Active Ingredient Amounts: Unapproved/counterfeit products may have different contents or ingredients, posing risks of being ineffective or overly effective【U.S. Food and Drug Administration】.

  • Cold Chain Failure: Temperature control is crucial for botulinum toxin. Improper shipping and storage can lead to inactivation or decreased safety.

  • Incompatibility of Dosage Units: Each product has different units of biological potency, making easy substitution dosing a trigger for overdose or toxicity.

  • Self-Injection Issues with Prescription Drugs: Prescription drugs require adequate diagnosis, suitability assessment, and aseptic technique. Self-injection can lead to infections, embolism, and nerve damage.

The FDA warning letter exemplified approved drugs such as Botox (onabotulinumtoxinA), Daxxify (daxibotulinumtoxinA-lanm), and **Myobloc (rimabotulinumtoxinB)**, reiterating the presence of a **strong "black box warning"**【U.S. Food and Drug Administration】.


Wider Impact: Not Just a U.S. Issue

In the summer of 2025, 41 cases of suspected botulism related to "fake Botox" were reported in the UK, prompting the regulatory authority (MHRA) to suggest severe penalties, including up to two years of imprisonment. Thousands of vials, mainly unapproved vials from Korea, were reportedly seized【The Guardian】. U.S. media reports also frequently mentioned injuries and toxic symptoms【CBS News】.

Furthermore, warnings have also been issued for counterfeit and unapproved distribution of

GLP-1 drugs (weight loss drugs)
, which is part of a broader trend towards strengthening the crackdown on "online pharmaceuticals"【Reuters】.


SNS Reactions: Polarization into Praise, Caution, and Opposition

This measure has generated

three streams

on social media.

  1. Praise from the Medical Community

    Dermatologists and others praised the move as "necessary for patient safety" and noted that awareness of the botulism risk from unapproved products
    has advanced. Dermatology Times posts and Instagram reels by U.S. dermatologist Heather Rogers strongly emphasized the trio of legitimate products, legitimate channels, and qualified professionals【Facebook】.

  2. Consumer Caution and Self-Examination

    The mood of self-examination
    spread, with questions like "Which sites are dangerous?" and "What about the store I've been buying from?" The FDA's official Threads post was widely shared, reminding consumers to check purchase sources, lot numbers, and seek medical attention if symptoms occur【Threads】.

    Opposition Regarding Price and Access
  3. Complaints about

    high clinic prices leading to personal imports and opposition to what some see as a "monopoly on healthcare" were also observed. Meanwhile, healthcare professionals pointed out the **"uncertainty behind the low prices"** and argued that the cost of treatment failures or sequelae is actually higher (Summary: Trend analysis based on media reports and social media posts【
    CBS News】).

    Self-Checks Consumers Can Do Now

Review Purchase and Booking Sources

: Avoid using the 18 sites

specifically named
    in this announcement. If applicable, organize
  • medical records, receipts, and lot numbers

    【U.S. Food and Drug Administration】. Monitor Symptoms: Seek immediate medical attention if symptoms such as

    swallowing and breathing difficulties, speech disorders, or muscle weakness
    • appear. Consider reporting to
  • MedWatch

    【U.S. Food and Drug Administration】. Check for "Legitimate x Licensed x Clinical Environment": Confirm in advance whether approved products are being used by

    qualified professionals in a medical environment
    • .

  • Be Cautious of Advertising Expressions: Be wary of

    excessive or misleading claims
    • such as "no need for storage," "self-injection OK," or "unit compatibility."



  • Tasks for the Industry and Platforms

Strengthening Marketplace Review

: Enhance

listing review and logistics audits
    for pharmaceuticals and medical devices categories.

  • Responsibility Sharing in Cross-Border E-Commerce: Ensure

    visibility
    • in shipping locations, temperature control, and customs clearance.

  • Counterfeit Label Measures in the Age of Generative AI: The introduction of

    forensic examination of label images
    • and
  • lot matching APIs

    will be key in the future.

    Summary

    The FDA's simultaneous warning is a clear red card against the new norm of "injections available cheaply, quickly, and online." Amid the fierce tug-of-war between
    • price
and
safety

, it is also a time to return to the very reasonable reality that **the cheapest option is "not failing."**

References and Sources

FDA News Release (November 5, 2025):
Official List of 18 Sites / Medical Consultation Encouragement / MedWatch

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