Peptides Law and Compliance

Lengea’s National Leadership in Peptide Regulation, Enforcement, and Risk Strategy

Peptides have rapidly moved from niche clinical use into mainstream medical aesthetics, wellness, and longevity practices across the United States. With that growth has come heightened scrutiny from federal and state regulators.

At Lengea Law, we are a national leader in peptide-related legal strategy. We advise med spas, wellness clinics, physicians, pharmacies, and healthcare entrepreneurs on how peptide products and services are regulated in practice, not just in theory.

As enforcement increases across the United States, our role is to help clients understand real regulatory risk, structure their businesses compliantly, and respond strategically when regulators get involved.

Why Peptides Are Under Increased Scrutiny

Peptides raise complex legal issues because they often sit at the intersection of multiple regulatory regimes, including FDA oversight, state pharmacy laws, medical and nursing board rules, and consumer protection statutes. As a result, regulatory authority may arise at both the federal and state levels, often simultaneously.

Regulators are focused on:

Use of non-FDA-approved peptide products
Compounding and sourcing practices
Interstate shipment and nonresident pharmacy activity
Scope of practice and supervision
Marketing and advertising claims
Unlicensed administration and improper delegation

What was once treated as a gray area is now an active enforcement priority.

How Lengea Law Helps Peptide-Focused Businesses

We work with clients at every stage of the peptide lifecycle, from early planning to active enforcement matters.

Compliance and Risk Assessment

Peptide compliance audits
Review of sourcing and compounding arrangements
State-by-state regulatory risk analyses
Scope of practice and supervision review
Consent forms and patient disclosures

Business Structure and CPOM Strategy:

Physician and non-physician ownership analysis
MSO and management services agreement structuring
Fee-splitting and revenue-flow review
Corporate practice of medicine compliance
Multi-state expansion planning

Marketing and Advertising Review:

Website and social media compliance
Review of peptide-related claims
Influencer and testimonial risk analysis
FTC and state consumer protection compliance

Investigations and Enforcement Response:

Pharmacy board investigations
Medical board investigations
Department of health and consumer protection inquiries
FDA- and FTC-related issues
Response strategy, negotiations, and settlements

We do not just draft documents. We help clients navigate regulatory pressure with clarity and confidence

Med Spas and Peptides

Peptides offered in med spa and aesthetic settings carry heightened regulatory risk. Regulators are closely examining:

Whether peptide services constitute the practice of medicine
Who is prescribing and supervising
Who is administering peptide therapies
Whether non-medical staff are involved
Whether business structures are compliant

We help med spas align peptide offerings with licensing, supervision, and corporate-structure requirements before problems arise.

Enforcement Informed Advice

What sets Lengea apart is that we advise based on enforcement patterns we are actively seeing across the country.

Our team regularly handles:

Board inquiries in multiple jurisdictions
Subpoenas and document requests
Cease-and-desist demands
Settlement negotiations
Ongoing monitoring obligations

This experience allows us to give clients realistic guidance grounded in how regulators are actually acting today.

Who We Work With

Our peptide practice serves:

Med spas and aesthetic practices
Wellness and longevity clinics
Physicians and physician groups
Pharmacies and compounding partners
Healthcare entrepreneurs and investors
Multi-state healthcare platforms
Healthcare influencers

Whether you are launching a peptide offering or reassessing an existing one, we tailor our advice to your business model and risk tolerance.

Why Lengea Law

Clients choose Lengea Law because:

We focus exclusively on medical aesthetics, wellness, and regenerative medicine health law
We understand peptides from a regulatory and operational perspective
We stay ahead of enforcement trends
We provide clear, practical guidance
We help our clients act early, not react late

Peptide compliance is not one size fits all. We help you make informed decisions in a rapidly evolving regulatory environment.

Frequently Asked Questions About Peptides and Compliance

Are peptides legal in the United States?

Some peptides may be lawful in limited contexts, but many commonly marketed peptides are not FDA-approved drugs and raise significant regulatory issues. Legality depends on the specific peptide, how it is sourced or compounded, how it is marketed, who prescribes it, and how it is administered.

Can med spas legally offer peptides?

In many cases, offering peptides in a med spa setting creates heightened regulatory risk. Regulators often view peptide therapies as medical services that require proper licensure, physician involvement, and compliant business structures. Whether peptides may be offered depends on state law and scope-of-practice rules.

Are peptides considered drugs by the FDA?

The FDA generally treats peptides marketed for therapeutic use as drugs. If a peptide is intended to diagnose, cure, mitigate, treat, or prevent disease, it is subject to FDA oversight. Many peptides marketed in the wellness and aesthetics space have not been approved by the FDA. Some have been approved, but their use in aesthetics, longevity, or wellness is considered off-label.

Can peptides be compounded by pharmacies?

Only certain peptides may be lawfully compounded, and only under strict conditions. Compounding must comply with federal law and state pharmacy regulations, including prescription standards, sourcing requirements, and patient-specific limitations.

Are peptide marketing claims regulated?

Yes. Marketing is one of the most common triggers for investigations. Claims related to healing, antiaging, weight loss, sexual performance, or disease treatment often attract scrutiny from regulators. “Wellness” language and disclaimers do not eliminate risk.

Who can prescribe peptides?

In most states, peptides treated as drugs may only be prescribed by licensed medical professionals acting within their scope of practice (e.g., physicians and advanced practice licensees). Regulators closely examine whether prescribing and supervision are legitimate and documented.

Can non-medical staff administer peptides?

This depends on state law and the nature of the peptide therapy. In many jurisdictions, peptide administration is considered a medical act requiring licensed personnel and appropriate supervision.

Why is peptide enforcement increasing in 2026?

Enforcement is increasing due to safety concerns, aggressive marketing, lack of FDA approval, and rapid growth of popularity in the aesthetics and wellness industries. Regulators are coordinating across agencies and states, leading to more investigations and public enforcement actions.

What agencies regulate peptides?

Peptides may be regulated by the FDA, FTC, state pharmacy boards, state medical boards, and state departments of health. In many cases, multiple agencies are involved in a single investigation.

What should I do if my business is contacted by a regulator about peptides?

Do not respond without legal guidance. Early responses often shape the outcome of an investigation. It is critical to understand the scope of the inquiry and develop a response strategy before engaging. You have the right to politely decline an investigator’s initial requests if you intend to be represented by counsel and instead provide your attorney’s contact information to the investigator.

How can Lengea Law help with peptide compliance?

Lengea Law advises peptide-focused businesses nationwide on compliance, business structuring, marketing review, and enforcement response. We help clients understand real regulatory risk and navigate scrutiny strategically.