The US Food and Drug Administration (FDA) has continued its clampdown on the illegal trade of black-market peptides by issuing a string of warnings to online sellers, as non-approved drugs within this class generate a significant interest amongst the public on social media.
The five warning letters, which were issued to US-headquartered Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations LLC dba Tex Peptides, all detail violations in FDA regulations related to the sale of new peptide-based drugs, which remain unapproved and unregulated.
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The FDA’s issues primarily centre around each company’s attempts to sell illicit weight loss products, with all five websites flagged in this crackdown advertising their own versions of Eli Lilly’s obesity candidate, retatrutide – a drug that is yet to secure approval within any global market. This comes a little after Lilly itself sounded the alarm on the drug’s burgeoning black market, which has begun to take off as some patients look to secure cheaper alternatives to branded weight loss medications.
All these companies are also offering illegal variations of Novo Nordisk’s blockbuster glucagon-like peptide 1 receptor agonist (GLP-1RA), semaglutide, which is marketed in the US as Wegovy for obesity and Ozempic for type 2 diabetes.
Weight loss drugs are not the only focus for these black market sellers, however, as the implicated companies have a variety of growth hormone release-stimulating, muscle-boosting and libido-enhancing therapeutics on their roster – including copycat versions of Theratechnologies’ recently approved abdominal fat-reducing drug, Egrifta (tesamorelin), Mighty Therapeutics’ muscle strength-boosting Barth syndrome peptide, Forzinity (elamipretide) and Cosette Pharmaceuticals’ hypoactive sexual desire disorder therapy, Vyleesi (bremelanotide).
From a review of each website, Pharmaceutical Technology found that all the companies in question are selling these peptides under the pretence that their use is strictly for laboratory research and development purposes only, and that they are “not for veterinary or human use”. However, the FDA refutes these claims, noting that evidence obtained from each website establishes that these products are intended for human use.
The letters also detail the potential public health dangers linked to unregulated injectable products, which the FDA says “can pose risks of serious harm to users” due to their capacity to directly enter the bloodstream and bypass the body’s natural defences against toxins and pathogens.
Black market peptide industry gains steam
The FDA cracks down on the illegal peptide trade as consumers increasingly turn to unapproved medicines for their potential to improve aesthetics such as muscle tone and fat distribution.
While the agency may be clamping down on some peptide sellers, its advisory board recently voted to relax peptide restrictions. This means specialised pharmacies could now secure the green light to provide multiple peptides without them having to go through full clinical testing.
In conversation with Pharmaceutical Technology, Karsten Eastman, CEO of regulated peptide developer Sethera, noted that there is a dire need for greater clarity of understanding around peptides and their potential amongst the public.
