Grey-market peptides: what nurses need to know

With ‘grey-market’ peptide use rising and regulatory lines increasingly blurred, Cahal McQuillan looks at the what nurses need to know to navigate the safety, legal and ethical risks surrounding these unproven treatments.

Thinner, stronger, smarter… the promise of peptides seems endless, and the trend is picking up pace.

The past few months has seen media coverage of wellness peptides surge.

From the BBC to the New York Times, it’s the same story – people are purchasing lab-made peptides from online suppliers and injecting them in pursuit of a wide array of unproven health claims.

Peptides are not new to medicine – GLP-1 is a peptide – but the wider trend centres on compounds that have not undergone rigorous testing for safety or effectiveness.

These products are unlicensed and typically circumventing regulation through labelling that reads ‘for research purposes only’ or ‘not for human use.’

Professor Amira Guirguis, the Royal Pharmaceutical Society’s (RPS) chief scientist, said: ‘Peptides that affect hormones, metabolism or tissue repair can have powerful effects on the body, yet products sold online as “research use only” are not regulated in the same way as licensed medicines.’

A spokesperson from the British Association of Medical Aesthetic Nurses (BAMAN) added: ‘The rising usage [of grey-market peptides] raises clear issues around patient safety, product quality and authenticity, lack of clinical evidence and absence of regulatory oversight.’

Peptides are short chains of amino acids that play a role in regulating hormones, releasing neurotransmitters, and repairing tissue. Insulin and as mentioned, GLP-1 therapies, are both well-established peptide-based treatments used to manage diabetes and weight.

Unlicensed variants – known as grey-market peptides – often carry obscure alphanumeric names such as BPC-157, GHK-Cu, and TB-500, and are touted as doing everything from accelerating injury recovery to enhancing sleep quality.

Their rise coincides with the GLP-1 boom and a broader cultural normalisation of self-injection. Today, peptides are most visibly promoted by influencers in wellness, fitness, and biohacking communities, spreading largely through social media.

Tom Micklewright, medical director at Orcha Health, a digital health assessment company, expressed his concerns about recent trends: ‘I worry that the increasing consumerisation of healthcare has watered down the understanding and perception of medical risk amongst the general public.

‘That means more individuals than ever before are willing to take a DIY approach to their own health, guided by online influencers with no medical training or experience.’

But the compounds have also found a more prominent platform. On the Joe Rogan podcast – the most downloaded podcast globally, with an average of around 11 million listeners per episode – US Health Secretary Robert F Kennedy Jr has spoken favourably about peptide therapies.

During his appearance Mr Kennedy signalled that action from the US Food and Drug Administration may be imminent, suggesting it could move to make around 14 currently unlicensed peptides – which were banned in 2023 because of potentially significant safety risks – more accessible through domestic compounding pharmacies.

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Regulations

No equivalent deregulatory signals have emerged in the UK, yet grey-market peptides appear to be circulating just as freely. What’s more, given how easily labelling appears to circumvent existing rules, questions remain about how effectively current regulations are in containing these products.

When Nursing in Practice asked the Medicines and Healthcare products Regulatory Agency (MHRA) for comment on grey market peptides and current regulatory guidance, Lynda Scammell, head of Borderlines, MHRA, said: ‘Peptide products may be sold as cosmetics, supplements and medicines, and depending on their intended purpose, they fall under different regulatory frameworks.

‘We disregard claims that products are for “research purposes” if it is clear that such claims are being used as an attempt to avoid medicines regulations. If there is evidence within the promotional material that the products are in fact unauthorised medicines intended for human use, we will take appropriate regulatory action.

‘The MHRA determines whether a product is a medicine on a case-by-case basis. If a product is classified as a medicine and is not appropriately authorised, we take regulatory compliance action, including the removal of the product from the UK market where necessary.’

However, they added: ‘Not all peptides fall under MHRA’s remit, for example, many peptides are sold for body-building purposes and in the absence of medicinal claims, these would not be considered medicines.’

Following Nursing in Practice‘s initial enquiries, the MHRA has since confirmed that they are reviewing a number of websites, including those of several clinics, related to peptide products that have been brought to their attention through several channels, as well as their own monitoring.

An MHRA spokesperson said: ‘Where a breach of UK medicines legislation is identified, we will take appropriate regulatory action.’

When asked about the current regulatory framework for peptides in the UK, Dr Syed Omar Babar, director of a private clinic in Leicester that offers peptide therapy under medical supervision, said: ‘The unlicensed products framework does have a decent regulatory framework in the UK.

‘However, the framework is for medications [and the] majority of peptides sit in a space where they are not medications, but [instead] lean more towards supplements. This classification is where the confusion arises.’

In light of both Dr Omar and Ms Scammell’s comments, Nursing in Practice contacted the Food Standards Agency (FSA) about peptides that are considered supplements. While the FSA does indeed regulate these compounds, their jurisdiction is limited to peptides that are orally ingested and not those that are injected.

Additionally, Nursing in Practice contacted the Office for Product Safety and Standards (OPSS) in relation to injectable peptides that are defined as cosmetics. OPSS said that these products fell under the jurisdiction of the MHRA.

What is considered a medicine?

The Human Medicines Regulations 2012 offers two definitions of a ‘medicinal product’. The first covers ‘any substance or combination of substances presented as having properties of preventing or treating disease in human beings’.

The second definition is: ‘Any substance or combination of substances that may be used by, or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological immunological or metabolic action.’

While some grey-market peptides may fall under the first definition, David H Reissner, chair of the Pharmacy Law and Ethics Association, argues that most grey-market peptides should fall within the second broader definition.

‘It seems to me that medical claims – or the absence of medical claims – would be relevant to the first definition, but not to the second definition.

‘Peptides used for body-building purposes, [for example], are a substance that may be used by human beings with a view to modifying a physiological function by exerting a metabolic action.’

An MHRA spokesperson pushed back on this interpretation, stating: ‘Case law has established that products which have the effect of modifying physiological function while having no beneficial effect on human health do not meet the definition of a medicinal product.’

Michael Saul, partner at Cosmetic Surgery Solicitors, expressed serious concerns over what he described as a ‘deliberately ambiguous space’ and a ‘regulatory middle zone’ that has formed in relation to injectable peptides.

Importantly, Reissner noted that: ‘If peptides are a medicinal product, then they are automatically a prescription only medicine because they are injectable – because [without the supervision of a doctor] their use is likely to present a direct or indirect danger to human health, even when used correctly’.

This designation, according to Reissner, would have significant consequences for the industry as ‘it is not lawful to advertise prescription only medicines to the public and it is not lawful to sell or supply them except in accordance with a prescription.’

An MHRA spokesperson said: ‘The definition of a medicine does not allow us to consider the mode of administration in isolation so… while injectable medicines are automatically prescription only medicines, injectable products are not automatically medicines.’

Mr Saul concluded: ‘Suppliers appear to be structuring their businesses in a way that avoids falling squarely within medicines legislation, whilst still reaching a consumer audience.’

Availability for purchase

Despite regulatory ambiguity, mainstream media reports, market prediction websites, and Google trends data indicate that the grey-market peptide industry and the public’s interest in it is growing in the UK.

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Given that numerous peptide wholesalers are selling products online without customer vetting and health clinics around the country are increasingly offering peptide therapies, the issue is gaining prominence.

Some private clinics appear to be navigating this uncertainty through the use of patient disclaimers. Dr Micklewright said: ‘I am seeing more private businesses operating that offer these ‘research-only’ peptides to patients and justify their practice by asking patients to sign disclaimers, accepting the risks and consenting to the treatment.’

Private clinic owner Dr Omar acknowledged this, saying: ‘The key thing for users to understand is that these products are unlicensed and we make clear during the consenting process as to the implications of this – informed consent is vital.’

In terms of delivering unlicensed peptide therapies safely, he added: ‘We have a decent amount of information on how certain peptides work, some peptides are already licensed, and we have detailed information on dosing and side effects.’

‘At [our clinic], we have experience using peptides for various use scenarios and have access to a network of doctors across UK and the US where we can share data and knowledge on how to best use peptides, their side effects, and how to best dose them.’

Suppliers, meanwhile, maintain that they operate within current guidance. UK Peptides told Nursing in Practice that it supplies ‘strictly on a research-use-only basis’ and its terms ‘explicitly prohibit human application.’

When pressed on the issue of individuals buying for personal use, however, the company told Nursing in Practice: ‘there is no practical or established framework for suppliers to verify end-use at point of sale. These materials have legitimate applications within appropriate settings, and responsibility for their correct use rests with the purchaser.’

Nevertheless, UK Peptides also acknowledged wider concerns about standards across the sector, stating that ‘greater clarity and consistency across the sector would be beneficial in supporting both public safety and industry accountability, particularly where it helps distinguish responsible suppliers from those operating without appropriate standards.’

UK Peptides emphasised that they ‘place a strong emphasis on quality, consistency and traceability, [and] maintaining these standards is resource-intensive and represents a key distinction between established operators and lower-cost entrants.’

Dr Omar added: ‘Banning the use of peptides would be a disservice to the public, but tighter controls on their sales may be an area that can be explored by regulators.’

For practitioners offering peptide therapies under medical supervision, the question of liability is not straightforward. Mr Saul warned that professional obligations remain enforceable regardless of where a product sits in the regulatory landscape: ‘People in that position do not get a free pass because the product sits in a grey market. The professional obligations of those administering it are far clearer and enforceable.’

‘If [medical professionals] provide treatments that are not supported by a responsible body of medical opinion, or fail to obtain properly informed consent, they may be exposed to clinical negligence claims’

Mr Reissner noted that, ‘The General Medical Council may interest itself in whether [a healthcare provider] can be satisfied that there is sufficient evidence of the use of peptides for a clinical purpose’.

What nurses need to know

For nurses being asked to offer grey-market peptides, a spokesperson from BAMAN said: ‘BAMAN’s Code of Professional Conduct emphasises that nurses must prioritise patient safety, evidence-based practice, and adherence to legal and regulatory frameworks at all times. The use of unlicensed substances obtained outside regulated supply chains is fundamentally misaligned with these principles.’

Their position was clear: ‘Nurses should not offer or administer unlicensed peptide therapies that lack appropriate regulatory approval, robust evidence, and clear legal frameworks. Nurses must practise within their scope of competence and adhere to all relevant medicines legislation and MHRA guidance.’

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They concluded: ‘Promoting or offering treatments with unproven claims would breach ethical advertising and professional standards.’

For nurses who encounter patients who are using grey-market peptide therapies, or are considering doing so, BAMAN advises taking the opportunity to educate them by clearly ‘explaining the lack of regulation and evidence and highlighting potential risks, including contamination, dosing uncertainty, and unknown side effects.’

BAMAN also said nurses should ‘advise against unregulated products based on safety concerns, and signpost to regulated care where appropriate.’

In light of the news that the MHRA is investigating several clinics offering peptide therapies, we asked BAMAN what nurses at such clinics should do if asked to administer them.

‘BAMAN Code is clear that nurses must act where there is a risk to the public or a breach of statutory guidance, and that responsibility cannot be transferred to an employer or organisation. Do not proceed if the treatment is not compliant with medicines legislation. Escalate the issue and seek external advice if needed,’ it said.

A version of this article was first published on our sister title, The Pharmacist.