The public record

My testimony at the FDA

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs

· FDA public hearing

Watch Dr. Lakisha®'s testimony in the FDA's full hearing recording, beginning at 1:22:04.

Watch from my testimony on YouTube

The player connects to the full YouTube hearing recording, beginning at the starting point identified by Dr. Lakisha®. It is not an edited clip or a transcript. The FDA's official agenda lists Lakisha Jenkins-Samuels of Kiona Foundation as a public commenter in the session on provider training, credentialing and patient safety.

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Official FDA record

FDA public comments: Product identity, patient safety and community governance

The public record now contains two linked submissions from Dr. Lakisha Jenkins-Samuels concerning her September 14, 2026 hearing testimony. Comment FDA-2026-N-7542-0170 records the oral testimony and one-page prepared statement. Comment FDA-2026-N-7542-0209 publishes the fuller written comment filed on September 24, 2026.

The fuller comment draws on lessons from more than 25 years in botanical medicine to make a basic distinction: a botanical genus is not a specific therapeutic product. It asks FDA to carry product identity from clinical investigation into post-approval care and real-world evidence. Its recommendations center on three priorities:

  1. Identify each product by regulatory or manufacturing category, source material, preparation, composition, dosage form, dose, route, manufacturer or sponsor, and batch or lot.
  2. Train every care-team member, address amplified power imbalance and protocol-permitted physical contact in informed consent, and provide an independent pathway for reporting harm and boundary violations.
  3. Compensate community partners for governance work, measure access and screening exclusions, and preserve harmonized identity fields so trial and real-world data can be interpreted together.

Her central conclusion was direct: Community governance is safety infrastructure.

Read the fuller written comment
Download the fuller written comment PDF
Read the oral-testimony submission
Download the oral-testimony PDF
View FDA docket FDA-2026-N-7542

Prepared written statement

Regulations.gov publishes both official submissions: Comment FDA-2026-N-7542-0170 documents the oral testimony and its one-page statement, while Comment FDA-2026-N-7542-0209 carries the fuller six-page written comment. The text below reproduces the prepared statement provided by Dr. Lakisha® for the September 14, 2026 hearing. It is not a word-for-word transcript of the video. The recording above is the record of what was spoken.

Good afternoon. I am Dr. Lakisha Jenkins-Samuels, a botanical research scientist and public policy strategist. I chair the Community Steering Committee of the University of Miami's Global Cannabis and Psychedelics Research Collaboratory, directed by Dr. Denise C. Vidot, and I am Founder and President of the Kiona Foundation, a 501(c)(3) nonprofit focused on novel botanical drug discovery and cancer research.

I speak for myself today. I have no financial relationship with any psychedelic drug developer, manufacturer, or service provider.

I have personally witnessed what we are experiencing in this season before in the field of cannabis as therapeutics. Years of records still cannot answer basic questions and patients lack clear answers on the best formulations for their health needs. Some say standardize later. I beg to differ.

Three things that can be done now to not follow the same failed path toward ambiguity:

Name the medicine. Record details of the psychedelic or compound, the preparation, dose, route, and lot, consistent with the Agency's own botanical drug development guidance. And show profiles of who benefits, who is left out, and who is harmed in an open, transparent format.

Train the entire care team, from administration and study design, to screening and follow-up. Include traditional and community practitioners. Teach everyone on the team what the medicine is before they are involved in giving it. Create a platform where patients have a way to report harm that does not run through their provider.

Bring the community in as partners and compensate them. There are existing successful models that do this now, such as the University of Miami’s Global Cannabis and Psychedelics Research Collaboratory. Keep space for the people who have traditionally held this medicine, they belong in the room where the rules are written. Measure access in cost, travel, language, disability, and time away from work when creating budgets for research, development, implementation, and dissemination.

Community governance is safety infrastructure. Those are the simple facts. Thank you.