Longevity drugs need endpoints that predict clinical benefit

Clinical takeaway: Off-label prescribing of already approved drugs for longevity stands on the strongest legal footing short of a longevity approval, the authors argue, though manufacturers generally cannot promote those uses. 

Longevity companies are drawing billions of dollars in US investment. Their products reach consumers through clinics and direct sales, promoted for muscle strength, cognition, and tissue repair. None of the widely marketed ones is FDA approved for an anti-aging indication, though some carry approval for unrelated uses such as diabetes or organ transplant, and many have never been approved for any use. 

Some commentators argue that longevity products sit in a regulatory gray area in part because FDA doesn't recognize aging as a disease. Others accept that an approval pathway exists but fault the lack of one built for longevity, saying the ambiguity keeps products from legally reaching the market. At a July 2026 meeting, an FDA advisory committee weighed whether compounded peptides, including some used for longevity, could be sold without FDA approval. A policy commentary by three authors answers both positions under the Federal Food, Drug, and Cosmetic Act and turns to the evidence longevity trials would need. 

The authors conclude that most longevity products clearly meet the federal drug definition, which reaches any product intended to affect the body's structure or function, not only those meant to treat disease. How FDA views aging therefore doesn't decide whether it can regulate or approve them. The authors point to hair growth products and onabotulinumtoxinA for facial lines, both approved as drugs without a targeted disease, and to two canine drugs that FDA has recently shown willingness to approve for longevity indications without a disease claim. 

The harder obstacle, they write, is largely scientific. Approval often rests on surrogate endpoints, and the field has no consensus on which ones to use for longevity trials. Candidate measures that could be linked to the biology of aging were discussed at a May 2026 public meeting convened by the Reagan-Udall Foundation for the FDA with the Advanced Research Projects Agency for Health. The authors aren't sure aging itself qualifies for accelerated approval, which is limited to serious or life-threatening conditions with unmet need, though specific age-related diseases could. Classifying aging as a disease wouldn't necessarily make approval clearer or faster either, they add, because the difficulty lies in measuring long-term clinical benefit. 

Labels and workarounds don't change the legal status, in their account. Injectable, topical, transdermal, and nasal products can't be dietary supplements because they aren't ingested, and neither can products aimed at age-related diseases. Companies that sell unapproved drugs as research chemicals without an Investigational New Drug application generally violate US law, and state right-to-try expansions generally can't exempt them from federal requirements. Off-label prescribing applies only to drugs already approved for another use, and many products popular for longevity aren't approved for any use. Such products stay widespread, the authors say, because FDA has enforced these requirements inconsistently and the financial incentives to market them are substantial, not because the requirements don't apply. 

The authors call on FDA, regulatory counterparts abroad, and research funders to work with longevity researchers on which study designs and evidence would be both feasible and sufficient for a rigorous standard. They name several routes to endpoint validation: the National Institute on Aging's Translational Geroscience Network, which has more than 80 affiliated trials, formal meetings with FDA and the Biomarker Qualification Program, and the XPRIZE Foundation's healthspan competition, which awarded funds in August 2026 to teams running clinical trials. Enforcement carries its own constraint, the authors add, since without a budget increase FDA may have to redirect considerable resources from other priorities. 

"Rather than leaning into deregulation, dedicating resources to validating endpoints and to enforcing existing regulation is what will best serve the public, advance science, and promote innovation," the authors conclude. 

Source: Strassle C, et al. (2026 Oct 1) Science. Longevity products: Innovation through regulation