The Impact of Reclassifying 7-OH Products

On Aug. 14, 2025, Florida Attorney General James Uthmeier issued an emergency rule filing to classify certain 7-hydroxymitragynine (7-OH) products as Schedule 1 controlled substances in Florida, making it illegal to sell, possess, or distribute certain 7-OH drugs in the state (1). This action follows FDA’s July 2025 recommendations to control concentrated 7-OH products under the Controlled Substances Act. Those recommendations now head to the Drug Enforcement Agency for review (2).

To find out how these government actions may impact the pharmaceutical industry, Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council. White sees the actions as helping pharmaceutical manufacturers combat those companies wishing to circumvent regulations.

“Pharmaceutical companies have to spend a billion or more dollars in order to be able to bring their drugs to market and have to be able to prove the benefits and the risks of those products. Here, you don't have to do any of that. All you have to do is take a product, put it in a well-marketed form, and then just put it out on the shelves and see what happens. And that's not a good way to be able to have a healthcare system,” White says. “So, I think [FDA’s and Florida’s decision] is going to be good, because it helps to underscore that there should be one way that these chemicals are coming out onto the market and that it's the same level playing field for everyone.”

Click the video above to watch the interview.

References

1. Makary, M.A. Statement from FDA Commissioner Marty Makary, MD, MPH, on Florida Restriction of 7-OH Opioid Products. FDA.gov. Aug. 13, 2025. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products
2. FDA. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. Press Release. July 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

About the interviewee

C. Michael White is Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy. He is also the Chair of the Kratom Consumer Advisory Council. He has been a clinical pharmacology and evidence synthesist researcher for more than 27 years and focuses on reducing drug, dietary supplement, device, and procedure-induced diseases.