The FDA has recently announced a proposal to amend the current Investigational New Drug (IND) application regulations. The proposal involves 2 exemptions for clinical investigations involving lawfully marketed foods (including functional foods and dietary supplements) and cosmetics from IND requirements when they are being studied to be used as a drug.

Background

The purpose of an IND application is to help ensure the safety and rights of participants in clinical investigations are protected, and to ensure the quality of data is adequate to permit the evaluation of the safety and effectiveness of a drug for which marketing approval is sought.

What is the purpose of the proposal?

1. To help expedite clinical investigations involving lawfully marketed foods and cosmetics by precluding them from the IND pathway.
2. To help incur cost-saving benefits by reducing the number of IND applications filed with the FDA.

There are 2 exemptions proposed:

1. Self-determined exemption: Food or cosmetics would be exempt from IND requirements if the following requirements were met:
   • The investigation is not intended to support a drug development plan, including a future IND or application for marketing approval.
   • The investigation is conducted in compliance with an institutional review, informed consent, and commercial distribution of investigational drugs:
     • Meeting with the requirements for institutional review in 21 CFR Part 56 and the requirements for informed consent in 21 CFR Part 50; and
     • Meeting with the requirements of § 312.7.
   • The route of administration is the same as that of the lawfully marketed product.
   • The investigation meets the following participant health, safety, and welfare requirements:
     • No participants below 12 months.
     • No pregnant or lactating mothers.
     • No participants with compromised immune systems.
     • Does not restrict participants from taking a prescribed therapeutic.
     • Does not increase risk beyond routine physical or psychological evaluations or standard of care procedures.
     • The product is being used in a way that is consistent with its labelled conditions of use.
     • No other product taken by or used to treat subjects during the investigation would significantly increase the risks (or decrease acceptability of the risks) encountered in the investigation.
2. FDA-determined exemption: Some products may not meet all the safety-related eligibility requirements for the self-determined exemption, however, the FDA might conclude that the study does not pose a significant risk to the health, safety, or welfare of participants. In order to meet the FDA-determined exemption, products must meet the following requirements:
   • The product must be lawfully marketed in the United States as a Food or Cosmetic.
   • FDA would require a copy of the study protocol including:
     • Design and duration.
     • Proposed endpoints.
     • Study population – including inclusion and exclusion criteria.
     • Investigational product description including all ingredients, formulation, and labelling information.
     • Dosage form and dosage regimen.
     • Route of administration.
     • Study procedures.
     • Protocol changes in the event of an adverse/serious adverse event.
   • Indicate which participant health, safety, and welfare requirements cannot be met, and provide evidence that the investigational product does not pose a significant risk to:
     • Participants less than 12 months of age or pregnant or lactating.
     • Participants with compromised immune systems or serious or life-threatening diseases or conditions.
     • If participation requires cessation of therapy or treatment prescribed by a healthcare practitioner.
     • If the study procedures expose participants to more risk than they would ordinarily encounter during routine physical or psychological evaluations or standard-of-care procedures.
     • If the proposed conditions of use of the product in the investigation differ from the product’s labelled or ordinary conditions of use.
     • If the investigational product is being used concurrently with other products that a subject is taking or being treated with, either as part of the study or as prescribed or recommended by a healthcare provider outside the study.

This article provides a supplemental review of the FDA proposal titled “Investigational New Drug Applications; Exemptions for Clinical Investigations To Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic”, and is not a substitute for reading the full proposal.

If you would like to submit a comment to the FDA regarding this proposal, the deadline for comments is March 9, 2023.

For more information about this article, or any other regulatory affairs matters, please contact us using the form below.