CPS Faculty Expert Steve Kates Warns of Safety Gaps in Booming Peptide Industry
by CPS Communications
CPS adjunct faculty member and pharmaceutical executive Steve Kates weighs in on the safety gaps behind the booming peptide industry in a recent Newsweek article, alongside other researchers and industry experts.
The July 30 feature looks at the explosive growth of the peptide and longevity industry — now part of a combined $6.8 trillion wellness market — and the regulatory debate unfolding as the FDA’s Pharmacy Compounding Advisory Committee weighs loosening restrictions on several previously banned peptide compounds, a shift championed by HHS Secretary Robert F. Kennedy Jr.
The article draws on perspectives from across the field, including a pharmacy founder and a longevity-company medical officer who argue a regulated pathway is safer than the unregulated gray market, as well as academic voices urging more caution.
Safety Standards Have Not Kept Pace with Demand
Kates — who teaches at CPS and brings nearly three decades of pharmaceutical R&D experience, including senior regulatory affairs roles at Takeda and Dicerna Pharmaceuticals, and authorship of more than 100 papers, patents, and reviews on peptide chemistry — told Newsweek that peptide products flooding the wellness market haven’t cleared the standard bar required for drug approval: demonstrated efficacy, validated manufacturing, and toxicology testing.
He also pointed out that peptides’ inherently complex manufacturing process has historically made them difficult to produce reliably at scale, a structural factor behind the safety data lagging demand.
His comments echoed fellow Northeastern professor Mansoor Amiji of the Bouvé College of Health Sciences, who told Newsweek that outside a handful of FDA-approved exceptions like GLP-1 drugs, there is no clinical evidence establishing the safety of the “hyped” peptides now flooding the market.
