ICYMI, the FDA published the draft “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” rule in December of 2022. The comment period recently ended and it has many in the industry pondering its potential implications.
Clinical studies are necessary to substantiate the marketing of pharmaceutical products. FDA must approve the drug sponsor to conduct a clinical trial and this process is conducted via IND application. That is, unless the product is exempted. The proposed rule has some believing that foods, dietary supplements, and cosmetics may now have an easier path to make something beyond mere structure/function claims. Herein lies the reason for the industry interest in this new proposed regulation. Outside of FDA mandates for supplement facts panels, we have no suggestions for any warnings on the label.
If anyone thinks this means that you can say goodbye to the DSHEA days of “not intended to diagnose, cure, mitigate, treat or prevent a disease,” think again.
The language in the proposed rule is pretty deliberate. The intent of the draft rule is to expand the potential for exemptions to include food, dietary supplements and cosmetic products. This doesn’t mean that THESE products can be marketed as drugs. Instead, what it means is that if a researcher or a sponsor wants to study these products (and the potential impact that they can have on disease or other conditions) the study sponsor can seek an exemption. The mere act of studying the impact of a food, supplement, or cosmetic on condition does not mean that sufficient evidence has been provided to warrant a drug claim on those products. Rather, it just makes it easier to study.
Nevertheless, the increased access for researchers or sponsors to study foods, supplements, and cosmetics is a good thing. It can contribute to increased understanding of pharmacological reactions, thereby increasing clinician trust in allowing patients to continue with their dietary supplement regimen.
The take home message is that while it will remove a great barrier to studying dietary supplements and foods for health benefits, it does not change any regulatory restrictions. Companies will not be able to market the products classified as dietary supplements for the disease state. What it will potentially do is remove barriers to studying foods and supplements to determine the health benefits or effects of a substance. The American Society for Nutrition states “IND application exemptions will more readily allow for nutrition research in the U.S. to support future health claims designed to help consumers make healthier food choices and for nutrition research to support federal dietary recommendations and policies, such as the Dietary Guidelines for Americans and Dietary Reference Intakes.”
