A second lawsuit demands that FDA respond to a 2024 citizen petition to classify aging as a disease; the court dismissed the first suit by the same plaintiff a year ago over a missing signature, never reaching the merits
A second lawsuit demands that FDA respond to a 2024 citizen petition to classify aging as a disease; the court dismissed the first suit by the same plaintiff a year ago over a missing signature, never reaching the merits
On September 16, 2026, Ali Afshar filed a lawsuit against the FDA and its acting commissioner Kyle Diamantas in the United States District Court for the Southern District of New York. The suit seeks to compel the agency to finally issue a substantive response to a 2024 citizen petition asking it to classify aging as a disease, a question the FDA has left unanswered on the merits for over two years. Afshar filed on behalf of Age Reversal Unity, an initiative that has been pursuing this classification since 2024.
The case was docketed as 1:26-cv-08147; Afshar paid the $405 filing fee himself, and the court has already issued a summons. The court cannot itself classify aging as a disease, but under the Administrative Procedure Act it can compel the FDA to issue some kind of response to the petition Afshar filed on behalf of Age Reversal Unity on May 22, 2024: approval, denial, or a commitment with a specific deadline.
A citizen petition is a standard mechanism that allows any person in the United States to ask a federal agency to adopt or amend a regulation; under FDA rules, the agency must respond within 180 days. Afshar asked the FDA to declare aging a disease: it remains the shared underlying risk factor for heart attack, cancer, diabetes, and dementia, and such a classification would open a regulatory pathway for drugs targeting the aging process itself. The only substantive reply from the agency came nearly 10 months later, in a letter dated March 21, 2025, from an FDA assistant commissioner for policy: the matter requires further analysis, and the agency has plenty of other priorities as it is. Another year and a half has passed since then without a single new word from the FDA.
For geroscience, this is the impasse: the FDA approves drugs against individual diagnoses, not against the general process of aging that underlies them. The TAME trial with metformin worked around this impasse by using a composite endpoint spanning death, heart attack, stroke, cancer, and dementia. Afshar took the direct route: he wrote to the agency, filed an appeal, and ultimately went to court.
His first attempt came a year earlier, on September 8, 2025. The judge required him to either pay the filing fee or file an application to proceed in forma pauperis; Afshar chose the second option, and the case sat idle for five months. In March 2026, the judge demanded a page of the complaint bearing a wet signature or the case would be dismissed. The requirement was not met, and on April 23, 2026, the suit was dismissed for the missing signature. The court never considered whether the FDA was obligated to respond on the merits.
In the second lawsuit, Afshar paid the filing fee upfront rather than filing a poverty application.
"The $405 filing fee has been paid. Case No. 1:26-cv-08147-UA," he wrote on X a week later.
The case was again assigned to the same judge, Laura Taylor Swain, the chief judge of the Southern District of New York, who has simultaneously been overseeing Puerto Rico's multibillion-dollar government debt restructuring since 2017. She was assigned on September 24, the same day the Senate held a confirmation hearing for permanent FDA commissioner nominee Heidi Overton. The defendant named in the suit, Kyle Diamantas, is the first lawyer to serve as FDA commissioner; he has held the position in an acting capacity since May 2026.
Age Reversal Unity, on whose behalf Afshar has been pursuing all of this since 2024, is an X account with 1,158 followers and a website whose hosting has been suspended. The initiative has no office, no staff, and no attorney; Afshar represents himself. In over two years of letters, an appeal, and two lawsuits, the only substantive response from the FDA remains a single letter citing lack of time.