Content Operating System ROI one-pager · Reg. 0108
The business case

One system, one line item, and a compliance review you never have to explain after the fact.

You don't need to sell your own team on supplement compliance. You need three minutes and a page that makes the number obvious.

Download the one-page PDF PDF · one letter page · 61 KB

What getting it wrong costs

Every supplement or wellness brand runs this risk whether or not anyone has written it down: a claim your content team wrote goes out, and it draws attention it shouldn't.

Outcome 01
A warning letter

A structure/function claim crosses into disease territory, which makes the product an unapproved new drug under FDA rules. Separately, FTC governs whether the claim was substantiated in advertising.

Either way you have fifteen days to respond in writing. The letter is published on FDA's site and stays there. Close-out letters are posted far less reliably, so the letter routinely outlives the fix.

Outcome 02
A pulled listing

Platform enforcement runs on its own timeline and its own standard. Amazon monitors FDA's enforcement database and deactivates ASINs for brands that receive warning letters, and it also acts independently.

One seller documented losing an ASIN they had sold for more than ten years over the phrase “helps reduce occasional stress and anxiety,” a claim their own FDA/FTC counsel had confirmed as permissible.

Legal sign-off does not bind the platform. The copy layer is where it gets decided.

Outcome 03
A response engagement

Outside counsel to answer a warning letter, billed hourly, roughly $300 to $500 an hour for boutique FDA/FTC regulatory work. That is the bill for a problem that is already public.

Hourly rate, not a total. A response engagement runs as long as the letter takes to answer.

Why this system specifically

None of the above is a compliance failure in the usual sense. Each one starts as a sentence somebody wrote on a deadline, with no framework telling them where the line was.

12
Years in the category
250+
pieces personally run through this system
11
Brands built
0
FDA warning letters on content produced under my oversight

Built by Heather L. Makar. Not a course. A system your team keeps and reuses, not a lecture sat through once.

The investment

Tier Price What it gets you Tier 01The Book $247 Full written system: the manifesto and the framework, the nine claim categories with compliant and noncompliant examples, and the redline method worked end to end. Tier 02 · Most chosenThe Working System $597 Everything in Tier 1, plus the Customer Journey Map, Compliance Risk Audit and Marketing Materials Audit workbooks, the Compliance Quick-Reference Pack, the Notion + Claude Project Template (eight pillars), the Marketing AI Prompts Library, the 90-day implementation roadmap and the 30-day implementation drip. Tier 03The Operator's Edition $1,997 Everything in Tier 2, plus the 15-Week Guided Implementation, the Annotated Worked Examples Library, the AI Partnership Setup and Quarterly System Health Audit workbooks, and quarterly Compliance Update PDFs for three years.

Seven-day refund on all tiers.

One time, then ongoing

The math an approver will ask for

Tier 2 costs $597, one time. It does not replace a compliance review and is not built to.

What it changes is what arrives at review: claims already sorted by category, language already screened against structure/function limits, and a documented rationale attached to each piece. The review still happens. It has less to fix, and fewer rounds to fix it in.

This isn't insurance you hope not to use. It's the framework the content team applies to every claim going forward. The cost is one time, the use is ongoing.

See the three tiers → Read the full system
Take it with you

One page, letter size. Everything above, on a single sheet. The PDF is the file to attach to an email; the print sheet is the same page in the browser, if you would rather print it yourself.

Download the one-page PDF Or open the print sheet in the browser