(Editor’s note: This story is part of a recurring series of commentaries from professionals connected to the hemp industry. Jason Mitchell is a naturopathic doctor, co-founder and CEO of HempFusion Wellness and a board member for the U.S. Hemp Roundtable.)
The U.S. Food and Drug Administration recently rejected two notifications to market hemp extract as a new dietary ingredient.
But your company still needs to go through the process of completing one, too.
If Congress approves one of two pending bills, this will officially allow CBD to be sold as a dietary supplement and open the door for a wide range of new dietary ingredient notification (NDIN) submissions.
That gives your company two main reasons to go through the process of completing this dossier.
- First, when “Company A” has the first successful submission, it is a success for Company A and Company A alone. It’s not a win for the entire industry.
- Second, when the door opens and Amazon and mass retailers begin vetting for safe, legal brands, some may consider selling only brands that can prove successful NDIN submissions.
Every company’s biomass, extraction and manufacturing processes are different.
Unless your CBD company is white-labeling the successfully notified NDI material from Company A, at least 75 days before going to market, you must submit your own NDIN, including significant science and data demonstrating to FDA that your CBD ingredient is reasonably expected to be safe for consumers.
It may take up to three years before enough CBD companies have submitted successful NDINs, providing FDA with an enormous amount of science and safety data that could be applied more universally to other CBD ingredients in the market.
Second, when Congress acts, and CBD is officially regulated by FDA, Amazon, Target and other mass retailers will more than likely, and almost immediately, begin vetting for compliant brands.
It is expected that the only brands in consideration will be those that can prove they are compliant with FDA via a successful NDIN.
No mass retailer will make an exception, risking the trust and safety of their loyal consumers, for any brand. Those that are prepared and are successful will not only have access to the many retailers that are not currently selling CBD products, but they will also be among the select initial few that will be distributing products that are compliant and backed by safety data.
How to get there
The process of building an NDIN dossier is daunting.
A company should reasonably expect to spend at least $500,000 and potentially up to $1 million, depending on the complexity of the submission.
It can take at least 18 to 24 months, or longer, to prepare for such a submission.
A company can expect that the submission will be many hundreds of pages, explaining why your CBD ingredient is expected to be safe when used as directed.
At a minimum, this includes an extensive description of the identity and composition of the NDI, detailed manufacturing descriptions, certificates of analysis, an examination of adverse effects associated with the use of the ingredient, and several layers of time-consuming safety studies.
To build a complete NDIN dossier, the following are just a few of the elements that may be required:
(It is important to mention that the below list does not illustrate the complexity of time and resources it would take to complete. Each line item requires one or all the following: a third-party lab, research institution, third-party publisher, peer-review panel and so much more. It is also important to mention that many of these line items are dependent on one of the others. Meaning that from a timing perspective, one must be completed before the other can even start.)
Comprehensive safety profile research data:
- History of use.
- Evidence of safety.
- Human observational study.
- Bacterial reverse mutation assay.
- In vivo micronucleus study.
- Maximum tolerated dose study.
- 90-day repeat dose study.
- Comparable evidence of safety of other hemp products.
- Human studies. ]
- Genotoxicity / Mutagenicity in vitro.
- Genotoxicity / Mutagenicity in vivo.
- Oral toxicity.
- Effects on blood coagulation.
- Effects on immune system.
- Reproductive toxicity.
- NOAEL (No Observed Adverse Effect Level).
- Determination of safety factor.
- Determination of safe level intake (“ADI”).
- Determination of estimated daily intake and estimated daily Intake to accepted daily intake Ratio (EDI / ADI Ratio).
Description of the ingredient:
- Full composition.
- Properties of the ingredient.
- Proposed product labeling.
- Proposed use.
Manufacturing process and compliance:
- Summary of manufacturing process.
- Full description of the manufacturing process.
- Production flow chart
Product specifications and methods of analysis:
- Cannabinoid profile.
- Residual solvents (or proof of the absence of).
- Heavy metals.
- Stable methods of analysis
The above list provides an outline of sorts.
But this list is far more comprehensive than it looks because many of these steps have dependent requirements that can take months to complete. Many of the items must be done in order, and if the test is interrupted or fails, you must begin again, setting your process back.
For the handful of companies that are equipped to complete the comprehensive, costly and time-consuming process of completing an NDIN dossier, know that rejections are common.
If the FDA finds deficiencies, it will notify the company (typically within 75 days) and provide the company with an opportunity to respond. If FDA finds that the deficiencies can’t be addressed quickly, then they will issue a letter rejecting the notification.
If FDA finds no objections, they do not “approve” your dossier.
Rather, by no objection within the specified time-frame, your ingredient will officially be considered a successfully notified NDI.
Ninety days after a submission, whether rejected or successful, the details of your notification will be available through FDA’s Division of Dockets Management. If your company plans to take on this Herculean task, it would be in your best interest to review those that have gone before you.
This process is far more difficult than one might think, and this is also not an exhaustive illustration of what might be required.
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