Peptides are rapidly becoming one of the most talked-about areas of the aesthetics, wellness, and longevity markets.

While some peptide-based medicines have established clinical uses and have been through formal medicines licensing processes, a growing number of products are being promoted online for purposes including fat loss, tissue repair, muscle growth, tanning, recovery and anti-ageing.

Products such as BPC-157, CJC-1295, Ipamorelin and Melanotan II are increasingly visible on social media and within the wider wellness market. Their growing popularity presents commercial opportunities for businesses, but it also creates potentially significant regulatory and criminal risks.

For clinics and healthcare professionals, consumer demand does not necessarily mean that a product can lawfully be supplied, prescribed, advertised or administered.

A peptide is not automatically a licensed medicine

One of the most important distinctions for practitioners is between a peptide that forms part of an authorised medicinal product and a substance being marketed as a “research peptide”.

Medicines placed on the UK market generally require an appropriate marketing authorisation unless a specific exemption applies. The fact that a substance is readily available online, described as a peptide or labelled “for research use only” does not itself determine its regulatory status.

The Medicines and Healthcare products Regulatory Agency (MHRA) can consider both the characteristics of a product and the way in which it is presented when determining whether it falls within the definition of a medicinal product.

This creates an obvious risk where products ostensibly sold as research chemicals are simultaneously promoted, directly or indirectly, for effects such as healing injuries, losing weight, stimulating growth hormone or otherwise modifying physiological functions.

Clinics should therefore be extremely cautious about assuming that the terminology used by a manufacturer or supplier determines the legal position.

“Unlicensed” does not mean unregulated

There is also an important distinction between the lawful use of an unlicensed medicine in appropriate clinical circumstances and products which have never been authorised as medicines and may have an uncertain provenance.

UK law provides circumstances in which certain unlicensed medicinal products can be supplied to meet the special needs of an individual patient. That does not create a general route for clinics to obtain experimental peptides and offer them as routine wellness treatments.

Where a practitioner is considering prescribing or administering an unlicensed product, questions are likely to arise around clinical justification, sourcing, prescribing responsibility, informed consent and whether the treatment falls within the practitioner’s competence and professional scope of practice.

For regulated healthcare professionals, the consequences are not simply commercial. Their decisions may potentially attract scrutiny from their professional regulator as well as medicines regulators.

Advertising peptides

Peptide treatments also create potentially significant advertising risks.

Prescription-only medicines cannot lawfully be advertised to the general public in the same way as ordinary consumer products or cosmetic treatments.

Clinics therefore need to consider carefully what is being said on websites, Instagram, TikTok and other promotional channels.

Using terminology such as “research peptide”, “biohacking” or “wellness treatment” will not necessarily avoid medicines advertising rules if the substance concerned is a medicinal product.

Practitioners should also be cautious about making claims concerning benefits such as injury recovery, fat loss, muscle growth or anti-ageing where those claims cannot be adequately substantiated.

The substance of what is being promoted is more important than the label attached to it.

Sourcing and supply chains

The growth of peptides has been accompanied by a significant online market for products obtained outside conventional pharmaceutical supply chains.

That presents an obvious patient-safety and regulatory issue.

A practitioner considering administering an injectable product should know precisely what it contains, where it has originated, how it has been manufactured and stored, and whether appropriate quality assurance exists. With products obtained through grey-market or internet suppliers, there may be uncertainty over concentration, sterility, contamination, labelling and even whether the vial contains the substance it purports to contain. A clinic administering such a product could consequently expose both the patient and practitioner to substantial risk.

Professional regulation and indemnity

Doctors, nurses, pharmacists and other regulated healthcare professionals remain subject to their respective professional obligations regardless of how innovative or fashionable a treatment becomes.

Before providing peptide-based treatment, practitioners should be able to justify why it is clinically appropriate, demonstrate that they are competent to provide it, explain material risks and uncertainties to the patient, and maintain adequate clinical records.

There is also a separate question that can easily be overlooked: does the practitioner’s professional indemnity insurance actually cover the treatment? Where a product is experimental, unlicensed or being used outside conventional aesthetic practice, practitioners should not simply assume that their existing cosmetic-treatment cover extends to it. That question is much better answered before a complication or regulatory investigation occurs.

When a regulatory issue becomes a police investigation

The potential consequences do not necessarily end with the MHRA or a practitioner’s professional regulator.

Where there are concerns about the unlawful importation, supply or sale of medicinal products, businesses may also find themselves facing criminal investigation.

This can significantly change the nature of the problem facing a clinic.

An investigation may extend beyond the individual products being supplied and examine how the business operates, where its products originate, who supplies them, what representations have been made to customers and how much revenue has been generated from the activity.

Where investigators suspect that money has been obtained through unlawful conduct, the Proceeds of Crime Act 2002 (POCA) can also become relevant.

For aesthetics and wellness businesses, this is an increasingly important area to understand. What begins as a medicines-regulation issue can develop into a much wider criminal and potentially civil investigation.

Account Freezing Orders

One of the financial investigation tools available to law enforcement agencies is an Account Freezing Order (AFO).

The AFO regime, introduced into POCA by the Criminal Finances Act 2017, allows an enforcement officer to apply to the Magistrates’ Court for an order freezing money held in a bank or building society account where the statutory conditions are met.

Broadly, the court must be satisfied that there are reasonable grounds for suspecting that money held in the account is recoverable property – property obtained through unlawful conduct – or is intended for use in unlawful conduct.

Crucially, an AFO does not depend upon the account holder first being convicted of a criminal offence.

That is particularly significant for businesses. A company may find access to substantial funds restricted while the underlying criminal allegations remain under investigation and before anyone has been charged, let alone convicted.

What does an AFO mean for an aesthetics business?

The practical impact of an account being frozen can be considerable.

A business account may contain money required to pay employees, suppliers, rent, tax liabilities and other ordinary operating expenses. Restricting access to working capital can therefore create immediate operational difficulties, regardless of whether the underlying allegations are ultimately established.

An AFO may also form part of a broader financial investigation into the provenance of money entering an account.

For an aesthetics or wellness business, that could mean scrutiny of payments received from patients, treatment records, invoices, suppliers, stock purchases and other transactions as investigators attempt to establish whether particular funds can be connected to suspected unlawful activity.

The terms of the order are important. POCA makes provision for exclusions from an AFO in certain circumstances, including for reasonable living expenses, legal expenses and to enable a person to carry on a trade, business, profession or occupation.

Businesses faced with an AFO should therefore obtain specialist advice promptly rather than simply waiting for the underlying investigation to conclude.

From freezing an account to forfeiting the money

An AFO should not be regarded simply as a temporary inconvenience.  An AFO can be in place for up to two years. 

POCA also contains an account forfeiture regime. Where an enforcement agency has concluded its investigation and considers money held in an account to represent recoverable property or property intended for use in unlawful conduct, it may then seek forfeiture of those funds.

The issue can therefore move from whether a business can temporarily access its money to whether it is entitled to retain the money at all.

The evidential and legal issues in such proceedings can be complex. They may include the alleged unlawful conduct, the connection between that conduct and the money in the account, the source of particular funds and whether the statutory requirements for continued freezing or forfeiture have been established.

Why does this matter for businesses supplying peptides?

This is where medicines regulation and financial investigation can intersect.

If investigators allege that particular peptides or other medicinal products have been unlawfully imported, supplied or sold, they may also examine the revenue generated by those activities.

In appropriate circumstances, an enforcement agency may contend that money generated through unlawful sales represents the proceeds of unlawful conduct.

An investigation that initially appears to concern the regulatory status of a particular product can therefore potentially expand into scrutiny of the business’s finances and the implementation of civil powers under POCA 2002.

Where suspected unlawful activity generates revenue, investigators may follow the money.

For clinic owners, this makes regulatory due diligence particularly important. Understanding what a product is, how it is regulated and whether it can lawfully be supplied is not simply a question of clinical governance. Getting that analysis wrong can have consequences for the wider business, and advice should be sought.

Due diligence before offering peptide treatments

The peptide market is developing considerably faster than many practitioners’ understanding of its regulatory framework.

Before adding a peptide treatment to a clinic’s services, businesses should establish:

• precisely what product is being supplied and its regulatory status;
• whether its proposed importation, supply, prescription and administration are lawful;
• whether it falls within the practitioner’s professional competence and scope of practice;
• whether advertising and social-media content comply with applicable medicines and advertising requirements;
• whether the supplier and supply chain can be properly verified;
• what evidence supports the treatment and any claims made about it;
• whether the consent process properly addresses known risks and areas of uncertainty; and
• whether the treatment is covered by appropriate professional indemnity insurance.

The fact that other clinics are offering a treatment is not evidence that they are doing so lawfully.

A developing enforcement landscape

Peptides sit at the intersection of several rapidly expanding markets: aesthetics, weight management, performance, longevity and preventative healthcare.

At the same time, aesthetics and wellness businesses are increasingly moving into areas traditionally associated with regulated healthcare, including prescription medicines, weight-management medication, hormone therapies and other novel treatments. That brings with it a much wider regulatory footprint. Depending upon the circumstances, a business could potentially attract the attention of the MHRA, professional healthcare regulators and law enforcement agencies. Where suspected unlawful activity has generated significant revenue, investigators may also turn their attention to bank accounts and assets.

For responsible practitioners, innovation does not need to be avoided. It does, however, need to be accompanied by proper governance and careful consideration of the regulatory framework.

Before introducing a new peptide treatment, the starting question should not simply be, “Can we offer this?”

It should be: “What exactly is this product, what is its regulatory status, and can we lawfully and safely provide it?”

For businesses operating at the rapidly developing intersection of aesthetics, medicine and wellness, the consequences of getting that question wrong can extend well beyond professional regulation. They can include criminal investigation, frozen bank accounts and proceedings seeking the forfeiture of funds alleged to represent the proceeds of unlawful activity.

Jonathon Enston is a Partner specialising in healthcare and aesthetics regulation. Lauren Bowkett is a Partner specialising in financial crime and proceeds of crime matters, including Account Freezing Orders.