This is a founder- and funder-facing deep dive into what you need to know right now to operate responsibly in psychedelics and adjacent categories. It's not legal advice—it’s operational survival strategy.

1. What You Think You Know (That Could Get You in Trouble)

• Why decriminalization ≠ legalization—and why approval ≠ commercial viability

• The problem with “research” that’s poorly designed, undocumented, or off the books

• The rise of backdoor IRBs, freelance scientists, and bad actors

• How ethical grey zones turn into regulatory disasters

You’ll gain: A grounded understanding of where things really stand—and why so many new ventures are misreading the map
 
2. The Claims, Language & Actions That Invite Scrutiny

• What actually triggers the FDA, FTC, or DEA—plus what investors often overlook

• How founders undermine credibility with language in pitch decks, websites, and marketing

• The specific claims and data types that suggest clinical activity—even if you don’t say “treat”

• Real examples of language that raised red flags—and how to avoid making the same mistakes

You’ll gain: A list of the most common mistakes—and a checklist to audit your own materials
 
3. How to Operate Responsibly—Without Losing Momentum

• What to document, disclose, and protect—even preclinical

• How to set up credible pilot programs without crossing into unauthorized research

• When and how to consult with regulatory, clinical, or scientific
  advisors (and what questions to ask)

• How to show funders and partners you’re serious—without
  overstepping what’s allowed

You’ll gain: A clear, practical path to build credibility and traction while
staying on the right side of regulation