Cannabinoid firms ready FDA ingredient notifications with eye on legalization

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(This is the sixth installment in an ongoing series offering tips and advice for marijuana and hemp extraction companies. The fifth installment is available here.)

Cannabis manufacturers with national ambitions for when the United States legalizes marijuana and CBD are plowing big money into telling the federal government exactly what they’re making – and being honest when their products elicit consumer complaints.

It can seem nonsensical to send the U.S. Food and Drug Administration detailed descriptions of a cannabis product for consideration for what the agency calls a New Dietary Ingredient, or NDI.

After all, cannabis isn’t new. And marijuana remains a Schedule 1, federally illegal drug, while hemp-derived CBD can’t legally be placed in food or dietary supplements outside pharmaceutical channels.

But a handful of companies are spending six figures and more preparing NDI notifications, all with an eye toward one day winning FDA clearance to market cannabis extracts when federal law changes.

NDI notifications – which involve a time-consuming approval process – give manufacturers an opportunity to show why their ingredients are safe and shouldn’t be considered adulterants.

NDIs are “dossiers that say, ‘This ingredient is safe for this intended use,’” said Johnel Imperio-Lagabon, an FDA compliance consultant with Burdock Group Consultants in Orlando, Florida.

And some see NDI notifications as the first step toward a future where regulators allow cannabinoids to be sold in foods and drinks.

“If you’re trying to sell your ingredient to a Fortune 100 company – the Coca-Colas and Pepsis of the world – they are likely going to require” FDA signoff, Imperio-Lagabon said during a recent webinar about NDI notifications hosted by Asa Waldstein’s Supplement Advisory Group.

How it works

The NDI process is for companies that want to sell substances in the U.S. that weren’t marketed as dietary supplements before 1994.

Notifications start with a requirement that companies describe the product they want approved. It sounds simple, but don’t be fooled.

The FDA will require a thorough ingredient and sourcing description, including solvents and extraction agents used in production, along with vetted dosage amounts and how the product is to be used. Many companies can’t complete that step.

“How are you going to get something approved if you can’t scientifically describe what it is?” Imperio-Lagabon said. “Characterize your ingredients. … If you can get that, you’re one step closer.”

Next, the manufacturer must show test results proving the ingredient is safe and how it should be safely dosed. Applicants must show:

  • Genetic toxicology studies.
  • Pharmacokinetic studies.
  • Animal toxicology studies.
  • Human clinical studies.

The studies can easily run into hundreds of thousands of dollars, Imperio-Lagabon said.

And the time they take explains why marijuana and hemp formulators are investing now in NDI notifications.

If all cannabis were legalized tomorrow, it would take years before cannabis ingredients would clear the FDA’s New Dietary Ingredient hurdles to bring cannabinoids such as CBD and THC-V to market without legal risk.

“Get your premarket safety information together now,” said Michael McGuffin, president of the Maryland-based American Herbal Products Association.

“And then, the day after (legalization) passes, you can put your ‘Forever’ stamp on it and mail it on in. It’s not too early.”

Rejection is OK

The process is so tricky that most initial NDI notifications are rejected by the FDA, even outside cannabis.

But those NDI rejections are valuable because they include insights into what federal regulators want to see before giving the green light to a dietary supplement. McGuffin recommends incorporating the insights and trying again.

“It’s not easy to get to the two-page letter that you want from the FDA,” McGuffin said. “Try, try again.”

For example, an NDI rejection can include questions about an ingredient’s origins, or how it was tested, giving manufacturers a road map for winning approval.

“They’re very detailed in their responses,” McGuffin said of FDA regulators. “They’ll give you almost a pathway to resubmit.”

Be upfront about complaints

Another counterintuitive aspect about the NDI process is called adverse-effect reporting, or reporting consumer complaints about your products from folks who had a bad experience.

Keeping track of those complaints shows a company is serious about safety and has plans to address adverse experiences. Older dietary-supplement manufacturers have been filing these kinds of reports for years.

“You’re going to have customer complaints. It happens in business,” McGuffin said. “You need to keep a file of those. …

“I don’t think there’s a problem with submitting those now. I don’t think the FDA is going to tell you you’re not allowed to submit it because you’re selling a product for which we haven’t yet created a pathway.”

Reports about consumer complaints underscore the entire reason why cannabis manufacturers are considering NDI notifications, he said.

“Act like you’re already regulated.”

Kristen Nichols can be reached at [email protected].