Medicines watchdog to investigate UK peptide clinics over health claims | Health

The medicines regulator is investigating whether UK clinics are breaking the law by making claims about the benefits of unregulated experimental peptide therapies, the Guardian can reveal.

Interest in experimental peptides has exploded in recent years. The substances are administered by injection and are touted by sellers, influencers and even some doctors as helping with everything from anti-aging to healing an injury.

There is little scientific evidence to support such health and wellness claims in humans. Where studies have been carried out, most involve animals or cells.

The Medicines and Healthcare products Regulatory Agency (MHRA) has said clinics are not allowed to make medicinal claims for peptide treatments offered through their service.

An MHRA spokesperson said: “If clinics offering peptide injections make medicinal claims for these treatments, the products will be considered medicines and subject to regulation under the Human Medicines Regulations 2012.

“The MHRA will take action against clinics identified as breaching legal requirements.”

However, a Guardian investigation found that a number of clinics operating in the UK offer a variety of unregulated experimental peptides and make numerous claims about their benefits on their websites.

The website for one of the top Google search results for peptide clinics in the UK states that Cortexin is “used for neuroprotection and cognitive enhancement”, that BPC-157 “helps with tissue repair and recovery from injury” and that Thymosin Alpha “boosts immune function”.

The MHRA confirmed that these websites were making medicinal claims for the peptide treatments offered, which were not permitted. After the Guardian contacted the clinic for comment, it removed the claims from its site.

Another top clinic in Google search results states on its website that peptides lack large-scale clinical trials and emphasizes that human evidence is limited, but it advertises seven named peptides and gives a “duration of results” and price for each, although it labels them as “research only.”

The clinic said its peptides cost £350 a month for a single peptide and £450 a month for two, with the treatment provided either in a vial with a disposable syringe or, for an additional fee, in pre-loaded injector pens.

When a Guardian reporter conducted a free consultation with the clinic, he was told that most peptide research was preclinical and that some peptides were still very experimental.

The clinician also said there was a lack of multicenter, randomized clinical trials of peptides to provide information on their long-term effects. They said the clinic advised taking four to eight weeks off between two to three month periods of using a peptide to reduce any risk.

However, the clinician recommended that the reporter consider taking two peptides to help with recovery from exercise and fatigue.

They said the first, BPC-157, was one of the most commonly used peptides.

“It helps with cell repair and recovery. So if someone comes to us and says I want to be fitter, lift heavier weights, have bigger muscles, I’m still going to recommend BPC-157, even if it doesn’t directly affect any of those things. That’s because it helps your recovery after those workouts,” the clinician said.

“This helps provide more blood flow and nutrients to different tissues that need repair… [and] promotes faster recovery from any physical activity you have performed.

The clinician said BPC-157 was not advised for people who smoke or have a family history of cancer because there was concern that the peptide could increase blood supply to these tissues and help fuel the cancer.

The second peptide recommended to the reporter was MOTS-C.

The clinician said: “MOTS-C is something that helps provide more stress resilience and better health to your mitochondria to be able to produce more energy cells…so the direct net effect for you would be a reduction in insulin resistance, better energy production in the form of [the energy molecule] ATP, and the net result of that is basically to reduce visceral fat.

The MHRA said it was investigating whether the clinician’s claims were medicinal.

The clinic said it had “clearly explained that the peptides discussed are not approved drugs and that the current evidence base is largely preclinical, with an absence of large-scale randomized controlled trials evaluating long-term outcomes.”

It said its consultations encouraged “shared decision-making, where individuals receive balanced information about potential mechanisms, theoretical benefits and uncertainties.”

A spokesperson said it was “important to recognize the current reality: a significant number of people in the UK already access peptide products through unregulated channels (including informal online networks such as messaging platforms), where there is little or no clinical oversight, quality assurance or safety checks.”

Peptides are short chains of amino acids. Some occur naturally in the body and have specific functions, for example the hormone insulin which helps regulate blood sugar levels.

But in recent years, there has been a surge of interest in using peptides for therapeutic purposes, from weight loss to anti-aging and wound healing.

These include approved prescription weight loss drugs made from synthetic peptides that mimic natural hormones, such as semaglutide and tirzepatide, found in weight loss drugs such as Wegovy and Mounjaro, respectively. But many other peptides on the market have not undergone the strict regulatory treatment that those used in drugs have and remain experimental.

According to the MHRA, a medicinal product includes “any substance or combination of substances claimed to have properties for preventing or treating disease in humans”. Illness includes “any injury, illness, or adverse condition, whether physical or mental.”

A medicine can also be “any substance or combination of substances capable of being used by or administered to humans with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis”.

Lynda Scammell, Head of Borderline Products at the MHRA, said: “Peptide products can be sold as cosmetics, supplements and medicines, and depending on their purpose they fall under different regulatory frameworks.

“The MHRA determines on a case-by-case basis whether a product is a medicinal product. This includes consideration of a number of factors, including the effect of the product on the body, how it is used, and takes into account all available evidence and relevant legal precedents.

“We ignore claims that products are intended for ‘research purposes’ if it is clear that these claims are being used to attempt to circumvent drug regulations. If there is evidence in promotional materials that the products are in fact unauthorized drugs intended for human use, we will take appropriate regulatory action.”