Fact check: Has Neurocept received FDA approval or emergency use authorization and what were the regulatory decisions and dates?

1. What advocates and critics are actually claiming about Neurocept — the headline dispute

Coverage alleging benefits for Neurocept principally comes from promotional materials and supplement marketing; independent watchdog reporting frames those claims as unsupported and emphasizes that consumers should trust FDA approval when evaluating medical effectiveness. One review explicitly labels Neurocept as a dietary supplement and states it is not evaluated or approved by the FDA for treating medical conditions, signaling that any therapeutic claims are not backed by FDA review ^[1]. Other consumer‑focused pieces that warn about false promises for Alzheimer’s and brain‑health products do not mention Neurocept directly but underline a broader pattern of unproven supplements making medical claims without regulatory oversight, which is the context in which Neurocept appears in the marketplace ^[4].

2. What federal records and filings show — the absence of formal FDA decisions

Searches of FDA filings and product clearances identified related device approvals and other company filings but do not list Neurocept as an FDA‑approved drug or device. A set of filings for a related company, Neurocatch Inc, and approvals for devices like the Neuroguard IEP System appear in FDA documentation, yet these records do not mention Neurocept by name and do not provide evidence of any FDA approval or EUA for a product called Neurocept ^{[2] [5]}. The absence of a public FDA approval notice, product code, or EUA announcement associated with the name Neurocept across the provided regulatory references is consistent with the conclusion that no formal FDA authorization exists for that product ^{[2] [5]}.

3. Timeline and dates — what the sources actually document

The most recent source that directly addresses Neurocept’s regulatory status is dated September 3, 2025, and states clearly that Neurocept is marketed as a dietary supplement and has not received FDA approval or emergency use authorization ^[1]. Earlier consumer‑education and watchdog pieces dating from 2021–2022 flagged the general problem of unproven Alzheimer’s products and do not show any intervening FDA action to change Neurocept’s standing ^{[4] [3]}. FDA actions noted in these sources concern other products — for example, approvals and regulatory shifts for Alzheimer’s drugs like Leqembi — but these are distinct from Neurocept and occurred on separate dates ^[6].

4. Competing explanations and possible reasons for confusion

Confusion arises because companies sometimes use clinical language or cite unrelated filings to imply regulatory legitimacy; marketing as a supplement lets a product be sold without FDA premarket approval, which can create a public impression of medical endorsement that does not exist. Some FDA filings tied to companies with similar names or to medical devices (Neurocatch Inc filings, Neuroguard IEP clearance) may be conflated with Neurocept in secondary reporting, producing mixed signals about regulatory status ^{[2] [5]}. Independent consumer alerts and watchdog reports consistently recommend verifying FDA approval when products claim disease treatment benefits, and those same alerts either omit Neurocept from FDA listings or explicitly state it lacks FDA evaluation ^{[4] [1]}.

5. Bottom line and what to watch next — verified actions to confirm status

Based on the available evidence, the verified bottom line is that Neurocept has not been granted FDA approval or an EUA as of the latest reviewed reporting (most recently 2025‑09‑03). To confirm any future change, check the FDA’s Drugs@FDA and Emergency Use Authorization web pages for formal notices and search FDA product databases for the exact product name; any official FDA authorization would be dated and documented there, unlike the current landscape where Neurocept is described as an unapproved supplement by multiple sources ^{[1] [2]}.