On September 22, 2025, an FDA action set off a tidal wave: tens of thousands of parents flooded a Facebook group overnight seeking dosing tips, video testimonials, and doctors willing to prescribe leucovorin for their autistic children. The result was a chaotic mix of earnest hope, medical ambiguity, and opportunistic commerce.

Why this matters now: a federal health agency moved to authorize leucovorin calcium tablets for cerebral folate deficiency while also framing the drug as promising for some autism symptoms. That partial endorsement—built, according to agency notes, on a “systematic analysis of literature published between 2009–2024”—left clinicians without clear dosing guidance and families scrambling for answers.

A social-media vacuum that filled overnight

The stakes are high. Autism affects an estimated 1 in 36 US children; the promise of a pharmacological intervention triggers desperate demand, commercial pressure, and the risk of harm from off-label use. The episode exposes gaps in regulatory communication, platform moderation, and clinical governance at a moment when trust in health institutions is frayed.

A social-media vacuum that filled overnight

What the approval actually was — and what it wasn’t

The FDA announcement on September 22 sent a deluge of parents into one Facebook group created in May. Membership jumped from about 8,000 to nearly 60,000 in days, according to group founder Keith Joyce, turning a support space into an informal triage center for medical advice and supplier links. “Within days I started seeing a difference,” Joyce told reporters about his own grandson—an anecdote that circulated widely and amplified the group’s reach.

With no central clinical guidance, the group rapidly layered conflicting information: parents posting observed benefits and adverse reactions, self-described nurses debating appropriateness, and affiliate marketers pushing folinic acid supplements. The online scramble was predictable: when regulators signal hope but stop short of specifics, social media becomes the de facto advisory body—and that advisory body is unvetted, uneven, and monetized.

Misinformation, marketplace harms and clinical friction

What the approval actually was—and what it wasn’t

The FDA’s action cleared leucovorin calcium tablets for a recognized indication, cerebral folate deficiency, and described evidence that suggests potential benefit for “some symptoms of autism.” Crucially, the agency’s decision rested on a literature synthesis rather than large randomized controlled trials—an unusual path for an authorization tied to neurodevelopmental outcomes. Experts caution that the body of evidence is small and heterogeneous, with key questions about which subgroups might benefit.

Policy prescriptions: where governance must act next

That scientific uncertainty matters because autism is not a single biological condition. Recent genomic and developmental research shows meaningful differences between early- and later-diagnosed autism, implying different underlying pathways and treatment responses. A one-size-fits-all message—that a pill can broadly treat autism—misreads the data and fuels unrealistic expectations among families searching for a clear answer.

Misinformation, marketplace harms and clinical friction

The informational void created by an ambiguous regulatory message was quickly filled by actors with commercial incentives. Group posts catalogued affiliate links, supplement sellers, and lists of clinicians alleged to be willing to prescribe off-label. Some parents reported rapid improvements; others reported worsening behavior—reports that cannot substitute for controlled safety data.

Clinicians also felt the strain. Reporting captured instances of providers refusing to prescribe despite the FDA action, leaving families stranded and forcing some to seek less reliable substitutes sold online. Danielle Hall of the Autism Society warned that announcing a putative treatment without robust, practically applicable guidance “fuels stigma and harms families who are left with more confusion than clarity.” The pattern is familiar: partial regulatory signals plus porous social media moderation equals a commercialized information ecosystem with real medical risk.

Policy prescriptions: where governance must act next

Sources

• Wired — Chaos, Confusion, and Conspiracies: Inside a Facebook Group for RFK Jr.’s Autism ‘Cure’ (2025-10-07)

• Wired — Autism Is Not a Single Condition and Has No Single Cause, Scientists Conclude (2025-10-06)

• U.S. Food and Drug Administration — FDA press release: Approval and labeling update for leucovorin calcium tablets (2025-09-22)