Regenerative Medicine Compliance:
Exosomes and Polynucleotides
Helping You Safely Incorporate Innovation Into Your Practice
The fields of aesthetics, wellness, and functional medicine are evolving rapidly, and regenerative therapies like exosomes and polynucleotides are at the forefront of patient demand.
However, incorporating these products into your practice without proper compliance can expose you to FDA action, medical board discipline, and malpractice liability.
At Lengea Law, we help practices understand the legal landscape—and stay ahead of it—so you can offer cutting-edge treatments while protecting your license, business, and reputation.
Exosomes: Know the Legal Risks Before You Inject
- Current Status: As of 2025, no exosome product has FDA approval for injection, IV use, or implantation.
- FDA Classification: Exosomes intended for systemic use are regulated as biological drugs under Section 351 of the Public Health Service Act.
- Legal Use: Exosomes may only be injected as part of an FDA-authorized clinical trial (under an Investigational New Drug, or IND, authorization).
- Risks: Using or marketing exosomes for injection outside of an IND setting is illegal and can result in:
- FDA Warning Letters
- Regulatory investigations
- License suspension or revocation
- Increased malpractice exposure
Important: Topical application (e.g., microneedling with topical exosomes) may fall into a regulatory gray zone, but even this use must be approached cautiously with clear patient consents and risk disclosures.
Polynucleotides: A New Frontier, But Still Regulated
- What They Are: Polynucleotides (PNs) are DNA fragments or chains derived from salmon or other biological sources, believed to support skin regeneration, hydration, and repair.
- Regulatory Status:
- Polynucleotide-based injectables are regulated as drugs or biological products by the FDA if intended for systemic administration (injection).
- Some polynucleotide serums used topically may avoid drug classification if marketed properly for cosmetic (not therapeutic) purposes.
- Risks:
- Injecting polynucleotide products without FDA approval is risky and can be considered the administration of an unapproved drug.
- Marketing these products as treatments for disease (e.g., “healing,” “DNA repair,” “tissue regeneration”) could trigger regulatory enforcement actions.
How Lengea Helps
We advise practices nationwide on how to legally integrate exosomes, polynucleotides, and other regenerative therapies, including:
- Vendor Due Diligence: We review biological product sourcing, Certificates of Analysis (COAs), and compliance documents so you know exactly what you’re buying and using.
- Clinical Protocols: We help you structure your procedures to minimize regulatory risks—whether you’re using these products topically or under a research framework.
- Patient Consent Forms: We draft customized informed consents that explain off-label, investigational, or non-FDA-approved status, protecting you from potential liability and risks.
- Marketing Compliance: We review and refine your marketing materials to avoid illegal and untruthful claims that could trigger FDA or FTC enforcement.
- Ongoing Compliance Support: With the regulatory environment constantly shifting, we offer regular compliance updates and legal guidance so your practice stays protected.
Why Compliance Matters
In today’s environment, “I didn’t know” is not a defense.
Patients are more informed than ever, regulators are more aggressive than ever, and practices that do not take compliance seriously are increasingly vulnerable to disciplinary action and liabilities.
At Lengea Law, our mission is simple:
Help you innovate safely, grow confidently, and protect everything you’ve built.
Frequently Asked Questions About Exosomes and Polynucleotides
Are exosomes legal to inject into patients?
No. As of 2025, no exosome product has FDA approval for injection, IV, or implantation. Exosomes intended for systemic use must be regulated as drugs or biologics under a 351(a) designation. Using or injecting exosomes outside of an FDA-authorized clinical trial (IND) is illegal and puts your license, business, and patients at serious risk.
Can I microneedle exosomes into the skin?
Microneedling with topical exosomes is a regulatory gray area. While topical application (without systemic injection) carries somewhat less risk, it still requires proper patient consent and clear disclaimers. Marketing these treatments as “medical” or “healing” rather than purely cosmetic can also trigger FDA or state board scrutiny.
Are polynucleotides (PNs) legal to inject for skin rejuvenation?
Only if the product is FDA-approved for that specific use—which currently, most polynucleotide products in the U.S. are not. Injecting unapproved polynucleotide products could be considered the unauthorized use of an unapproved drug, exposing you to FDA enforcement and professional liability.
Can I use polynucleotide serums topically in my practice?
In some cases, yes. If a polynucleotide serum is marketed strictly for cosmetic purposes (e.g., improving the appearance of skin) and is applied topically without systemic effects, it may not require FDA drug approval. However, claims must be carefully worded to avoid triggering drug classification.
What happens if my practice uses non-compliant products?
You could face:
- FDA inspections and warning letters
- State medical board investigations
- Insurance liability and malpractice claims
- Loss of medical license
- Lawsuits from injured patients
- Financial penalties
Regenerative medicine offers immense potential but comes with significant risks. Working with a legal partner like Lengea will help you navigate these challenges and operate confidently.
Ready to Safely Add Regenerative Treatments to Your Practice?
Contact Lengea Law today to schedule a Regenerative Medicine Compliance Consultation and find out how to protect your business while safely offering the latest innovations.