Is Lanluma FDA Approved – What’s the Status?

Dermal fillers must pass stringent FDA scrutiny—reviewing everything from clinical trial data to manufacturing quality—before earning the agency’s seal of approval for patient use. This rigorous process helps ensure that only devices meeting the highest standards for safety and efficacy reach U.S. aesthetic practices.

Lanluma, a poly-L-lactic acid (PLLA) injectable designed to stimulate collagen, has won CE mark clearance in Europe and MHRA approval in the U.K., but it remains unapproved by the FDA for cosmetic use in the United States. Until the FDA grants approval, no U.S. clinic can legally market or inject Lanluma.

In this article, we’ll unpack Lanluma’s current regulatory status, compare its standing across different regions, and outline what these approvals mean for practitioners and patients considering this treatment.

Key Takeaways

• The FDA has not approved Lanluma for cosmetic use in the United States, so no U.S. practitioner can legally market or use it.
• Lanluma holds CE mark clearance for use in the European Economic Area and MHRA approval in the U.K., reflecting different regulatory standards from the FDA.
• The active ingredient, poly-L-lactic acid (PLLA), stimulates collagen production. Results appear gradually over 6 to 12 weeks and last up to two years or more.
• In regions where it has approval, practitioners use Lanluma for facial rejuvenation, volume restoration, and body contouring, including popular treatments like the Lanluma bum lift.
• U.S. medical professionals must comply with FDA regulations to avoid legal and professional risks, including malpractice claims and disciplinary action.
• Providers should clearly communicate Lanluma’s regulatory status to patients, explain the difference between CE marking and FDA approval, and discuss safer FDA-approved alternatives.
• Transparent, compassionate patient discussions help build trust, ensure informed consent, and support ethical aesthetic practice.
• Ongoing vigilance about regulatory changes and patient education is essential for practitioners navigating global cosmetic product approvals.

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Lanluma’s CE Mark vs. FDA Approval

The CE mark confirms that Lanluma satisfies the EU’s rigorous health, safety, and environmental directives, enabling its use throughout the European Economic Area. Under this certification, many embrace Lanluma widely for the following:

• Facial rejuvenation and soft tissue augmentation
• Volume restoration in areas like cheeks and temples
• Body contouring procedures, such as the Lanluma bum lift

In contrast, the FDA demands an extensive approval pathway that includes:

• Phase I–III clinical trials assessing safety and efficacy
• Ongoing post-market surveillance plans
• Strict manufacturing and quality control standards

Because Lanluma lacks FDA approval, it cannot be legally marketed or injected in the U.S. This regulatory gap underscores the importance of exploring alternatives and setting clear expectations around treatment availability. For patients curious about how long Lanluma lasts, it’s vital to understand that U.S. providers must recommend FDA-cleared options.

Clinical Use of Lanluma in Non-FDA Regions

In countries where Lanluma is approved, it is commonly used for various aesthetic procedures, including facial rejuvenation, volume restoration, and body contouring. One of its most in-demand applications is the Lanluma bum lift, which provides subtle, natural-looking enhancement without surgery or implants.

The active ingredient in Lanluma, poly-L-lactic acid (PLLA), is a biocompatible substance that has safely served medical applications for over 30 years. Once injected, PLLA stimulates the body’s collagen production, gradually improving skin texture, firmness, and volume.

Results are not immediate but begin to appear within 6 to 12 weeks as collagen builds beneath the skin. With proper aftercare and occasional maintenance sessions, these improvements can last up to two years or more. 

Implications for U.S. Medical Professionals

Staying compliant with FDA regulations is essential to protect both patients and practitioners. Key considerations include the following:

Consideration	Details
Regulatory Compliance	Lanluma is not FDA-approved and cannot be legally marketed or administered in the U.S.
Legal Liability	Use of unapproved products may expose providers to malpractice claims and legal penalties.
Professional Risk	Practitioners may face disciplinary action from licensing boards for using off-label devices.
Patient Safety	FDA approval ensures rigorous testing for safety and efficacy, which is key to ethical practice.
Best Practice	Stick to FDA-approved injectables and disclose the approval status of any discussed treatments.

Staying updated on product regulations helps safeguard both clinical integrity and patient trust.

Patient Communication Regarding Lanluma’s Status

Practitioners should adopt a clear, compassionate approach when discussing Lanluma with patients. It’s vital to acknowledge that Lanluma, while CE-marked, is not FDA-approved in the U.S. and explain what this distinction means in everyday terms. This conversation not only informs patients about the legal availability of the treatment but also underscores a commitment to patient safety and informed consent.

Key discussion points include:

• Regulatory Status: Explain that Lanluma carries a CE mark but lacks FDA approval for cosmetic use in the U.S., preventing legal administration in American clinics.
• Safety and Efficacy: Compare the CE process with the FDA’s rigorous clinical trials and post-market surveillance, showing why FDA clearance remains the gold standard.
• Legal Implications: Outline the potential legal risks and liability concerns associated with using non-FDA-approved products, stressing the importance of adhering to U.S. regulations.
• Treatment Alternatives: Provide a curated list of FDA-approved injectables, highlighting their safety profiles, expected outcomes, and maintenance schedules to help patients weigh their options.
• Patient Involvement: Encourage questions and dialogue, offer evidence-based resources, and schedule follow-up consultations to address ongoing concerns.

By combining empathetic dialogue with detailed information, clinicians can foster patient trust, reinforce ethical practice, and guide individuals toward safe, effective aesthetic choices.

Conclusion

Lanluma’s CE approval underscores its safety and effectiveness for facial rejuvenation and body contouring outside the U.S., but its lack of FDA clearance means that American practitioners must continue to rely on approved injectables to uphold both legal standards and patient safety. Clear, honest communication about Lanluma’s regulatory status—and the availability of FDA-endorsed alternatives—empowers patients to make informed choices aligned with their health goals.

Looking ahead, staying informed on evolving regulations and maintaining open dialogue with patients will remain essential. By prioritizing compliance and patient-centered education, providers can navigate the complexities of global cosmetic product approvals while delivering ethical, effective, and satisfactory aesthetic care.

FAQs

1. Is Lanluma FDA-approved for use in the United States?

No, Lanluma does not have FDA approval for use in the U.S. right now.

2. What does CE marking mean for Lanluma?

CE marking indicates that Lanluma complies with European Union safety, health, and environmental protection standards, allowing its use within the European Economic Area.

3. How long do Lanluma results typically last?

Results typically begin to appear within 6–12 weeks and, with proper care and maintenance, can last up to 2 years or longer.

4. Can U.S. practitioners legally use Lanluma?

No one can legally market or use Lanluma in the U.S. without FDA approval.

References

Ballin AC, Brandt FS, Cazzaniga A. Dermal fillers: an update. Am J Clin Dermatol. 2015;16:271-283. https://doi.org/10.1007/s40257-015-0135-7

Amselem M, Fatsea D, Forte R, Hasenöhrl C, Haus A, Salaabian A. Safety and effectiveness results of an innovative injectable poly‐L‐lactic acid‐based collagen stimulator (Lanluma®)—Clinical outcomes at 9 months in a post‐market study. Journal of Cosmetic Dermatology. Published online September 4, 2024. doi:10.1111/jocd.16527