(This is the sixth installment in an on-going series of tips and advice for marijuana and hemp mining businesses. The fifth installment can be found here.)
Cannabis makers with national ambitions for the US to legalize marijuana and CBD are investing large sums of money telling the federal government exactly what they’re doing – and being honest if their products cause consumer complaints.
It may seem nonsensical to send detailed descriptions of a cannabis product to the U.S. Food and Drug Administration to look into what the agency calls a New Dietary Ingredient (NDI).
After all, cannabis isn’t new. And marijuana remains a Schedule 1, a nationwide illegal drug, while hemp-derived CBD cannot legally be placed in foods or supplements outside of pharmaceutical channels.
But a handful of companies are spending six-digit or more digits on NDI filing preparation, all with the aim of one day getting FDA approval to market cannabis extracts if federal law changes.
NDI notifications, which include a time-consuming approval process, give manufacturers the opportunity to show why their ingredients are safe and should not be viewed as adulterants.
NDIs are “dossiers that say,” This ingredient is safe for this use, “said Johnel Imperio-Lagabon, FDA compliance advisor at Burdock Group Consultants in Orlando, Florida.
Some see NDI reports as the first step into a future in which regulators allow cannabinoids to be sold in food and beverages.
“If you’re trying to sell your ingredient to a Fortune 100 company – the Coca-Colas and Pepsis of the world – you will likely need FDA approval,” Imperio-Lagabon said during a recent webinar on NDI hosted by Asa -Notifications Waldstein’s Supplement Advisory Group.
How it works
The NDI process is aimed at companies looking to sell substances in the United States that were not marketed as dietary supplements prior to 1994.
Notifications begin with a requirement that companies describe the product they want to approve. It sounds simple, but don’t be fooled.
The FDA requires a thorough description of the ingredients and sourcing, including the solvents and extractants used in production, as well as the dosage levels verified and how the product will be used. Many companies cannot take this step.
“How can you get something approved if you can’t scientifically describe what it is?” Said Imperio-Lagabon. “Characterize your ingredients. … If you get that, you will be one step closer. “
Next, the manufacturer must provide test results showing that the ingredient is safe and how it should be safely dosed. Applicants must prove:
- Genotoxicological studies.
- Pharmacokinetic Studies.
- Animal toxicological studies.
- Clinical studies on humans.
The studies can easily cost hundreds of thousands of dollars, Imperio-Lagabon said.
And the time it takes explains why marijuana and hemp formulators are now investing in NDI notifications.
If all cannabis were legalized tomorrow, it would take years for cannabis ingredients to overcome the FDA’s hurdles for new dietary ingredients to bring cannabinoids like CBD and THC-V to market with no legal risk.
“Now is the time to compile your pre-market safety information,” said Michael McGuffin, president of the Maryland-based American Herbal Products Association.
“And then, the day after the (legalization) expires, you can put your ‘Forever’ stamp on it and mail it in. It’s not too early.”
Rejection is OK
The process is so difficult that most initial NDI notifications are rejected by the FDA, even outside of cannabis.
However, these NDI denials are valuable as they provide insight into what federal regulators want to see before giving the go-ahead for a dietary supplement. McGuffin recommends incorporating the findings and trying again.
“Getting that two-page letter that you want from the FDA is not easy,” said McGuffin. “Try it again.”
For example, an NDI rejection can contain questions about the origin of an ingredient or its testing, so that the manufacturers receive a roadmap for obtaining approval.
“They are very detailed in their responses,” said McGuffin of FDA regulators. “They almost give you a way to resubmit.”
Be open about complaints
Another counterintuitive aspect of the NDI process is reporting side effects or reporting consumer complaints about your products from people who have had bad experiences.
Following up on these complaints shows that a company is serious about security and has plans to address negative experiences. Older supplement manufacturers have been filing these types of reports for years.
“You will have customer complaints. It happens in business, ”said McGuffin. “You need to keep a file of it. …
“I don’t think there is a problem submitting this now. I don’t think the FDA is going to tell you not to file it because you’re selling a product that we haven’t figured out how to go about yet. “
Reports of consumer complaints underscore the entire reason cannabis manufacturers are considering NDI notifications, he said.
“Act like you are already regulated.”
Kristen Nichols can be contacted at [email protected].