What are FDA and regulatory statuses of NeuroGold and its ingredients?
Executive summary
Available sources show multiple unrelated entities using the name “NeuroGold” — a Berlin CBD company (Tracxn) and at least one dietary supplement / Manuka-honey product site — but none of the provided documents state any FDA approvals, NDAs, GRAS letters, 510(k) clearances, PMAs, or specific regulatory filings for any “NeuroGold” product [1] [2]. FDA rules distinguish drugs, devices, and dietary supplements; supplements can be marketed without FDA pre-approval but cannot legally claim to treat disease, per DSHEA and FDA consumer guidance [3] [4].
1. Who is “NeuroGold” — multiple brands, multiple claims
The name “NeuroGold” appears in business directories as a Berlin company selling CBD oils (Tracxn profile) and separately as an online supplement product claiming nerve-regeneration benefits with Manuka honey (company site) and as a branded phosphatidylserine supplement on retail listings [1] [2] [5]. These are commercial listings and marketing pages; the available sources do not report any FDA marketing authorizations tied to these names [1] [2] [5].
2. Regulatory pathway depends on how the product is positioned — drug, supplement, or device
The FDA treats drugs, devices, and dietary supplements under different rules. Drugs require premarket approval (NDA/BLA) and evaluation of safety and effectiveness; devices may need 510(k) clearance or PMA depending on class; dietary supplements are regulated under DSHEA and may be marketed without FDA approval unless they contain a “new dietary ingredient” requiring notification [6] [7] [3]. The available reporting does not indicate any NeuroGold product has pursued NDAs, BLAs, PMAs, or 510(k)s in the cited materials [6] [7] [3].
3. Dietary supplement claims and FDA oversight — what we can and cannot infer
Manufacturers can market dietary supplements without FDA pre-approval but cannot make disease-treatment claims; labels must avoid claims that would reclassify a product as a drug [3] [4]. The NeuroGold supplement pages promote nerve support and “restores damaged nerves” language on their storefront, but the sources here are promotional pages — not FDA determinations — and there is no cited FDA letter or warning about those specific claims in the provided material [2] [5]. Available sources do not mention any FDA enforcement actions against NeuroGold brands.
4. Ingredients: CBD, Manuka honey, phosphatidylserine and how FDA treats them
CBD’s regulatory status is complex and context-dependent; the provided Tracxn profile only identifies Neurogold as a CBD product maker and does not provide FDA filings or GRAS status for CBD ingredients [1]. Manuka honey and phosphatidylserine are common supplement ingredients; FDA maintains that some food ingredients can be GRAS but GRAS is a voluntary notification process and is ingredient- and use-specific [4] [8]. The sources do not include GRAS notices or NDI submissions for any NeuroGold ingredient; therefore, available sources do not mention regulatory clearances for these specific ingredients as used by NeuroGold [1] [2] [5] [4] [8].
5. What to look for if you need definitive regulatory status
To confirm formal FDA status you should search FDA public databases: Orange Book for approved drugs, Drugs@FDA and CDER pages for NDAs/BLAs, CDRH databases for 510(k)/PMA device entries, and FDA GRAS/NDI lists for food and supplement ingredients [9] [6] [7] [4]. The materials provided do not include entries for NeuroGold on those FDA registries nor any FOIA logs or FDA letters tied to the brand [9] [10].
6. Competing perspectives and limitations in reporting
Manufacturer marketing pages portray efficacy claims; statutory FDA guidance explains supplements need not be pre‑approved yet cannot claim to treat disease [2] [3]. Independent business directories simply list company activity but do not document regulatory compliance [1]. The sources provided do not include FDA enforcement actions, GRAS letters, NDI notifications, or cleared/approved applications for NeuroGold or its named ingredients; therefore I cannot assert that regulatory approvals exist beyond the general regulatory principles cited [1] [2] [3] [4].
7. Practical takeaway for consumers and clinicians
If a NeuroGold product is marketed as a dietary supplement, FDA pre-approval is not required but the company must avoid disease claims and may be subject to postmarket adverse event reporting and enforcement [3] [4]. If the product is intended to treat, cure, or prevent disease, it would legally require drug approval — which the sources do not show has happened for any NeuroGold offering [6] [2].
Limitations: this analysis uses only the supplied documents; searches of FDA databases, GRAS notifications, 510(k)/PMA records, and NDI filings beyond the supplied sources were not available here and may contain additional information not reflected above [9] [4] [7].