On Sept. 22, 2025, the U.S. Food and Drug Administration quietly expanded the labeled use of leucovorin calcium for cerebral folate deficiency — an arcane metabolic diagnosis — and a tidal wave of parents, sellers, and pundits crashed into the space between approval and practical guidance. A Facebook group swelled from a few thousand to roughly 60,000, trading dosing tips, conspiracy theories, and affiliate links.

Why this flare-up matters now is twofold. First, the FDA’s decision rested on a literature synthesis rather than large randomized trials; the agency acknowledged potential promise but left clinicians without standardized dosing or monitoring protocols. That gap has turned social platforms into a de facto clinical forum, where anecdote displaces evidence and commercial actors target vulnerable families (Wired: "Chaos, Confusion, and Conspiracies").

An approval from evidence assembled, not produced

Second, autism itself is heterogeneous — recent analyses argue it is a collection of conditions with different genetic and developmental profiles — which means a single pharmacologic "answer" risks overgeneralization and harm if policy and research do not follow fast (Wired summary of a Nature study: "Autism Is Not a Single Condition"). The next months will test whether regulators, clinicians, and platforms can close an information and safety gap before impulsive off-label prescribing and profiteering produce avoidable harms.

An approval from evidence assembled, not produced

From anecdote to marketplace: how social media filled the void

The FDA’s Sept. 22 announcement authorized leucovorin calcium for a specific indication: treating documented cerebral folate deficiency. But the agency’s decision diverged from the archetypal pathway of multiple-phase randomized clinical trials. Instead it leaned heavily on a systematic review of the literature spanning 2009–2024 — a patchwork of small studies, case series, and off-label experience that suggested benefit for subsets of patients.

That approach matters because it leaves crucial clinical parameters unspecified. The agency provided no universal pediatric or adolescent dosing algorithm, no standardized duration of therapy, and only limited guidance on monitoring for adverse events. In everyday practice, that vacuum forces physicians to decide on dose titration and safety thresholds without consensus, increasing variability in care and legal exposure for prescribers.

Ethics, heterogeneity, and who wins or loses

From anecdote to marketplace: how social media filled the void

Within days of the FDA notice, a grassroots Facebook group originally created in May exploded in membership, reportedly jumping from roughly 8,000 to nearly 60,000 people. Parents posted spreadsheets of willing prescribers, argued over appropriate folinic acid substitutes, and shared vivid accounts of rapid gains and severe adverse reactions alike. One parent described two-and-a-half weeks of marked behavioral change; another reported escalating agitation after starting the drug (Wired: "Chaos, Confusion, and Conspiracies").

Policy fixes that can be deployed fast

That mixture — ecstatic anecdotes, genuine safety concerns, and a flood of marketers pushing supplements and affiliate links — creates a high-risk ecosystem. Clinicians who feel rushed or pressured may prescribe off-label in ways that depart from best practice. Families desperate for improvement may self-medicate with over-the-counter folinic acid or buy products of variable potency and purity. The result: potential harm to children and fragmented data that regulators can’t easily analyze.

Ethics, heterogeneity, and who wins or loses

Platform governance and community engagement

The ethical stakes are square. Autism is not a single disease; genetic analyses show early-diagnosed and later-diagnosed autistic individuals often have different biological profiles. A pharmacologic intervention that helps a tiny, biologically defined subgroup risks being marketed, politically amplified, and imagined as a universal cure — a dangerous mismatch between scientific nuance and social desire (Wired summary of Nature study: "Autism Is Not a Single Condition").

Winners in this scramble are likely to be supplement sellers, clinic-based cash practices, and platform algorithms that amplify engagement. Losers will be lower-income families without access to careful specialist care, clinicians practicing in legally conservative health systems reluctant to prescribe, and, most importantly, children who may suffer adverse effects or miss out on supportive therapies while families chase a quick fix.

Policy fixes that can be deployed fast

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 & Drug Administration — Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices (2018-01-01)