Life After Legalization: Stephen Goldner Leads the Way to FDA


When FDA barriers change, regulations deal fortune to some and hardship to others. On March 4, 2016, at the California Cannabis Business Expo in San Francisco, Stephen Goldner, Senior Forensic Toxicologist at Quantum 9, a cannabis consulting and technology firm, addressed the U.S. Food and Drug Administration’s role in regulating the cannabis industry in life after legalization.

Goldner learned early on how to work with FDA to create new companies and industries, a task that now faces market participants in legal cannabis.

Goldner was on the team that developed the first commercial laboratory chromatography tests for drugs, launching the drug screening industry in the 1970s. Goldner and his mentor John Broich, both from the famous Brookhaven Labs, developed the liquid dose form of methadone, gaining FDA approval, which then allowed them to start, grow and successfully exit a company manufacturing methadone.

Goldner has harnessed his expertise to create a clear direction for life after legalization, a direction that has also opened the door for intelligent minds to create highly profitable opportunities.

On March 4, investors and industry members at the CCBE in San Francisco listened as Goldner gave an overview of FDA, plus real life examples demonstrating FDA protocols and operating practices that would apply to regulating legal cannabis.

“FDA has a very simple way to regulate things. They fit into categories. They know how to regulate tobacco, they know how to regulate smokable products that can cause a great deal of harm. They certainly know how to regulate drugs, medical devices and foods. It’s all about what the label claims are and what’s the ingredients,” Goldner said.

According to Goldner, it isn’t merely a matter of protocol to have the FDA regulate the claims of medical cannabis labels.

“Someone who wants to have relief from glaucoma, I don’t think I want them dosing themselves; I’m pretty sure FDA doesn’t want them self-dosing or self-diagnosing, but their doc knows how to be able to write script, it’s actually a large part of his or her business line. So I think that these will all work together synergistically.”

Beyond the fact that regulating dosages would benefit patients, FDA approval would create opportunities for distributors. The current distribution methods mirror OTC drugs and OTC foods, where a consumer walks into a drug store and buys a product right from the shelf. FDA approval would open up a new channel of distribution.

According to Goldner, “FDA approval certainly benefits the products; for example, getting 10 mg of THC approved in a tablet or capsule form will allow me to ship that product across state lines, export it to nearly every other country in the world. I won’t have to worry about whether it needs to be sold in a medical dispensary or a retail dispensary; it’ll actually be sold through hospitals and doctors.”

While Goldner gave great insight into FDA in a life after legalization, his ability to reflect upon the past as a means of informing the future was priceless.

“Forty-five years ago I took a molecule and I added some tang and I added some Metamucil to it. It couldn’t be abused that way. The Metamucil expanded. It’s called Jello. It couldn’t go through a syringe. It took a drug and it added flavor, color, and it helped be a laxative for heroin addicts who are frequently constipated, and it wouldn’t go through a syringe. So that’s a product. FDA looked at it, very simply, saw a safety margin. DEA saw a safety margin,” Goldner said.

With a safety margin ultimately in sight for cannabis, “This is a magic money moment, opportunity, for all of us. I’ve not seen a revolution like this.”

Caroline Cahill is the Managing Editor of MJINews. She earned her BA in Communications from College of Charleston and her MFA in Creative Writing from Virginia Commonwealth University. She has previously worked in higher education, development and radio. You can follow her on Twitter @CtheresaC.

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