Radicle Insights—FDA’s proposed IND exemptions rule

Executives from Radicle Science explain how FDA's proposed exemptions for clinical investigations to evaluate the drug use of a product could impact dietary supplement products.

Pelin Thorogood, Dr. Jeff Chenand 1 more

July 14, 2023

5 Min Read

Investigational New Drug (IND) applications are requests from clinical trial sponsors to obtain authorization from the Food and Drug Administration (FDA) to administer investigational drugs or biological products to humans.

IND trials are often conducted to collect safety and effectiveness information in support of marketing applications for biological and synthetic drugs.

Unless exempted, the sponsor for a clinical trial must obtain authorization from FDA for conducting the study by submitting an IND application. Traditionally in the wheelhouse of pharmaceuticals, a proposed recent amendment to the IND application process is now piquing interest from the functional food and supplement industry.

The proposed rule, entitled “Investigational New Drug Applications (INDs); Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic,” was published in December of 2022 with a comment period that wrapped up in March 2023.

This new amendment has the potential to usher in a new era for dietary supplements and foods. But, before you get your hopes up, there is some important background and fine print to consider. Namely,

Clinical trials on legally marketed drug products can sometimes be exempt from IND requirements. The proposed rule would expand these exemptions to include food, dietary supplements and cosmetic products. What does this mean? Overall, this proposed rule would expand the types of research that could be conducted on food and cosmetics without an IND compared to FDA’s current approach. Note that this doesn’t mean these products can be then marketed as drugs, so read on!
There are two pathways to secure an exemption. 1) Self-determined or 2) FDA-determined. With the self-determined route, a drug use study sponsor who intends to study a conventional food, supplement or cosmetic can determine if it is exempt from the IND regulations. This involves confirming a change will not be taking place to render the product an unlawfully marketed drug, the study is conducted in accordance with an institutional review board (IRB), there is no change to the route of administration (such as oral or dermal), and the studies meets other criteria to protect subjects’ safety and welfare. With an FDA-determined route, the agency determines the suitability of the exemption.
The exemption process will not exempt studies that are intended to support a drug claim on a food, supplement or cosmetic. This is the most relevant one for the supplements industry. FDA’s use of the word “drug use sponsor” is deliberate. It is clarifying the intent is to be able to make it easier to study the impact that certain foods, supplements and cosmetics can have on disease and other medical conditions, without enabling consumer-facing disease claims on these products.

These additional studies could also contribute to increased knowledge on the potential for pharmacokinetic interactions between supplements and drugs. These pharmacokinetic interactions pose a significant risk when, for example, an herbal supplement shares the same mechanism of absorption, distribution, metabolism or excretion (ADME) as a co-administered drug. Right now, the default recommendation for patients taking prescription medications is against supplement use where little or no data are available on the potential for specific herb-drug interactions.

Even with FDA’s continued position to not support a drug claim on a food, supplement or cosmetic, this new guidance can still be of great benefit to the industry. For example, any studies with the necessary underpinnings and rigor can still provide much needed data that can be used as the starting point for an FDA approval to support the use of these products for the treatment of disease.

Furthermore, any studies that offer greater awareness and understanding of supplement and drug interactions is likely to increase consumer and medical practitioner trust and confidence in supplements. This in turn could contribute to more consumer adoption via increased media coverage or healthcare provider recommendations.

It's important to note that when it comes to dietary supplements, stating or even implying a product will diagnose, cure, mitigate, treat or prevent a disease is still out of bounds and will land a brand in regulatory hot water. Recent Federal Trade Commission (FTC) health products compliance guidance and enforcement further bolsters this position.

The father of medicine, Hippocrates, said “Let food be thy medicine and medicine be thy food.” With this new proposed amendment this literally and figuratively could be the future of food and dietary supplements.

With a master of engineering and MBA from Cornell, Pelin Thorogood is a tech-executive-turned-impact-entrepreneur with a focus on data and analytics. She is the co-founder and executive chair of Radicle Science, with a mission to close the proof gap between supplements and pharmaceuticals. Thorogood is a trustee and treasurer of UC San Diego Foundation, co-chair of UCSD Innovation and Entrepreneurship Council, and industry scholar for the Cornell Institute of Healthy Futures.

A physician-scientist, Jeff Chen, M.D., is the co-founder and CEO of Radicle Science, which has pioneered a path for non-pharmaceuticals to clinically prove their true effects beyond placebo. He led clinical trials on natural products as the founder of a UCLA research center. After graduating from Cornell, Chen earned his medical degree and MBA concurrently from UCLA, where he is a David Geffen Fellow and UCLA Wolfen Entrepreneur.

Jaclyn Bowen is a food safety and quality systems engineer, and executive director of Clean Label Project, a nonprofit consumer advocacy organization with the mission to bring truth and transparency to food and consumer product labeling. Previously, she held numerous technical, standards development, food safety, quality and executive roles within the World Health Organization (WHO) Collaborating Centre, NSF International. Bowen holds masters’ degrees in quality engineering and public health management & policy.