Do you lead or write?
Both. I’m a Director/Head-level player-coach who owns strategy, approvals, Final MLR, and hands-on copy.

What qualifies as acceptable substantiation?
Peer-reviewed human data preferred (ideally RCTs); I tier evidence claims and map to FDA/FTC/DSHEA and platform policies with required disclosures.

Who approves substantiation and signs off?
build and lock the per SKU Claims & Substantiation Bank and sign Final MLR for copy/claims within scope. Legal is consulted and/or signs when policy requires or a material risk trigger is present.

How do you work with Legal/MLR?
I own MLR for copy/claims and loop Legal only for statutory or material-risk exceptions (e.g., disease adjacency; quantified or time bound efficacy not in the Bank; comparative claims; new jurisdictions; high risk ingredients; endorsements/UGC typicality; pricing/guarantees; sensitive audiences; prior denials; claims exceeding the mapped evidence tier).

What’s in the risk screen?
Category/SKU red flag terms, restricted phrasing/imagery, a quick contraindications/safety scan, required disclosures, and per channel watchlists (Meta/Google/Amazon, etc.).

Is label risk screening included?
Optional upstream add on. When engaged end to end, I complete label risk screening before we build the Bank.

When can the copy team start?
After Steps 1–3 are complete — no exceptions.

1. Bank v1 created and substantiation locked (per-SKU Claims & Substantiation Bank)

2. Outline/brief drafted by me (claim IDs + disclosures mapped, pre-brainstorm)

3. Guided brainstorm → ideas tied to valid claim IDs (or tagged Research). I then greenlight.

Timelines?
On average (business days): T+3 risk screen; T+7–10 Bank v1 delivered (MOA→USP claims, disclosures, initial ); T+17–20 first draft bundle from the copy team.

Which channels are covered?
Meta, Google, TikTok, Taboola/Outbrain/Yahoo, Amazon, ClickBank, DTC email/SMS, on-site — policy aware with documented guardrails updates tracked quarterly.

Who owns IP?
You do — all deliverables and the per SKU Claims & Substantiation Bank. Exceptions apply only to third party/licensed assets you provide or we mutually license. Mutual licenses are documented in the SOW.