FDA considers reversing restrictions on several peptides.

The US Food and Drug Administration (FDA) has recently announced that it is considering reversing restrictions on several peptide compounds.

This has sparked interest globally as an increasing number of social media influencers, celebrities and public figures have started to endorse their use for longevity and anti-aging.

Repeated pledges have been put forward by US Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger.

A particular peptide, BPC-157, is widely used in the US for inflammation and tissue healing, and is now gaining interest across multiple countries. Unlike pharmaceuticals, peptides on the market are not undergoing strict regulatory processes, including clinical trials.

Elizabeth Philp, CEO & Founder of the leading compounding pharmacy, Roseway Labs said: “The science is genuinely compelling, and clinicians are increasingly being asked about them. The issue is that demand has outpaced regulation, with many peptides on the market not undergoing the strict regulatory processes like those used in medications, including clinical trials.”

In the UK, peptides such as BPC-157 cannot be sold for use in humans. The MHRA will not permit them for human use because the active ingredients are not manufactured at sites regulated by a recognised authority such as the MHRA or FDA or equivalent.  Ingredients that are not approved for human use cannot be present in facilities that make human medication. 

Without that regulatory infrastructure, these ingredients cannot and should not move through legitimate pharmaceutical channels. What fills the void instead is a grey market, where products are labelled “for research use only,” sold with unknown purity, and consumed with no clinical oversight or industry-wide protocols.

Elizabeth comments, “Peptide molecules themselves are worth taking seriously. The issue is the absence of the infrastructure needed to use them safely.  There is no recognised analysis and quality control of the active pharmaceutical ingredient, no requirement to manage the temperature of the product during transit and storage, no adverse event tracking and ultimately, no way to verify what is in the vial. 

“For patients, this matters enormously. Purchasing peptides through grey market channels means you have no assurance of purity, dosage accuracy, or safety. Any UK clinician currently prescribing these compounds is taking on significant personal and professional risk.” 

Most consumers are aware of topical peptides, which have been around since the early 1970s^2,, but gained significant traction in the early 2000s with the introduction of palmitoyl pentapeptide-4 (Matrixyl) to specifically address ageing concerns.³ However, the medical application of injectable peptides began approximately a century ago with the advent of insulin therapy in the 1920s^4-5.

The latest surge in interest can be partly attributed to the continued popularity of topical peptides alongside an increased awareness of using peptides for therapeutic purposes such as weight-loss and injury recovery, as well as trends such as ‘biohacking’.  One class of peptides that consumers may have heard of without realising it are GLP-1 receptor agonists, such as semaglutide and tirzepatide, which are now widely prescribed for weight management and type 2 diabetes. 

References

¹https://www.independent.co.uk/news/uk/home-news/influencers-selling-peptides-tiktok-b2859168.html

² Pickart L, Vasquez-Soltero JM, Margolina A. GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration. Biomed Res Int. 2015;2015:648108. doi: 10.1155/2015/648108. 

³Robinson LR, Fitzgerald NC, Doughty DG, Dawes NC, Berge CA, Bissett DL. Topical palmitoyl pentapeptide provides improvement in photoaged human facial skin. Int J Cosmet Sci. 2005 Jun;27(3):155-60. doi: 10.1111/j.1467-2494.2005.00261.x.

⁴Almeida JR. The Century-Long Journey of Peptide-Based Drugs. Antibiotics (Basel). 2024 Feb 20;13(3):196. doi: 10.3390/antibiotics13030196.

⁵ Lau JL, Dunn MK. Therapeutic peptides: Historical perspectives, current development trends, and future directions. Bioorg Med Chem. 2018 Jun 1;26(10):2700-2707. doi: 10.1016/j.bmc.2017.06.052