As we are all adjusting to modifying our work practices to stay safe and “flatten the curve” during the time of COVID-19, work must go on. R&D, product development, and regulatory compliance are as important as ever as the FDA has been handing out warning letters for unsubstantiated coronavirus claims.
Many within the dietary supplement industry, especially those with new dietary ingredients, are wondering how COVID-19 and normal workplace disruption will impact New Dietary Ingredient Notification (NDIN) submissions. We at GRAS Associates (a Nutrasource company) can offer some of our experiences and perspectives with some frequently asked questions and answers.
Is FDA receiving notifications during the COVID-19?
Yes. The NDIN group is actively working on reviews and FDA staff are currently working from home. The submission process is electronic and as of October 19, 2019, notifications are received through the CFSAN Online Submission Module (replacing FURLS). GRAS Associates has found this to be a very user-friendly platform which is available 24/7.
Will I be able schedule a pre-meeting with FDA?
Yes. FDA has WebEx meetings available and we have found that meetings have been scheduled quite quickly with staff being available due to the no travel policies currently in place.
Are reviews for NDIN delayed due to COVID-19?
We have not found this to be the case to date.
Will I be able to make immune function support claims for my dietary supplement?
Yes, provided the claim is worded so that it is a structure function claim and not a drug claim and the structure function claim is adequately substantiated. Of course, no claim for treatment or cure of coronavirus is permitted and FDA has issued over 20 warning letters to companies allegedly selling unapproved products making claims related to treatment or cure of COVID-19.
Currently my company relies on published literature on individual ingredients in the formulation for substantiation but we want to perform a clinical trial on the formulation. Is it possible to initiate a clinical trial during the “shutdown?”
There are creative approaches for your clinical trial that can make research during COVID-19 possible.
To keep your study on track, strive for these goals: 1) reduce or remove the burden of work from the clinical trial site, and 2) prevent the need for travel or close volunteer-medic interaction.
Each study needs tailoring to its specific demands, but some general help rules can apply:
- Communicate with your Institutional or Ethics Review Board and provide a plan for Protocol Deviation
- Implement an electronic patient consent system
To learn more about clinical research solutions during social distancing precautions, read our recently published blog post.
Nutrasource has 18 years of experience guiding health products from concept to claim. Contact our team today to learn more about how we can support your regulatory and scientific needs during COVID-19 and beyond.
|Amy Mozingo, MS, is Director of Operations at GRAS Associates (a Nutrasource subsidiary). She has over 15 years of experience in industry and consulting, holds a certificate as a Preventive Control Qualified Individual (PCQI), and is trained and experienced in ingredient approvals (GRAS, NDIN, FAP, CAP), product labelling, formulation reviews, and current good manufacturing requirements for dietary supplements. Connect with Amy on LinkedIn.|