While we know the old adage chicken soup “cures” the common cold, decades of federal Food Drug Administration (FDA) enforcement have taught the industry that selling food as a “cure” renders it subject to criminal enforcement. It is not whether a food is effective to treat, prevent, mitigate, or cure a disease or condition, the question is whether you can conduct a study to find out. Until now, the answer was largely, “No!” On Dec. 8, 2022, the FDA took an important step in a proposed new rule entitled “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.”
The notion of food as a drug is widely supported, including by the White House, the National Institutes of Health, American Heart Association, Aspen Institute, and other health and academic organizations. Moreover, many retailers have in-house nutritionists generally promoting food as medicine.
The proposed rule provides exemptions from investigational new drug applications (INDs) for food and cosmetics, mirroring those available for approved drugs and treating legally marketed food as equivalent to a legally marketed drug.
The proposed rule creates two pathways: The “self-determined exemption” and the “FDA-determined” exemption. The self-determined exemption is available if the study:
- Is not intended for drug development or a drug labeling change;
- Complies with the Institutional Review Board (IRB) requirements and informed consent;
- Complies with non-promotion and commercial distribution regulations;
- Employs the same route of administration as the lawfully marketed product; and
- Is protective of the health, safety, and welfare of participants.
The proposal will impact food, dietary supplement, and cosmetic suppliers as well as health organizations and insurers and will apply to “foods,” “dietary supplements,” and “cosmetics” defined as follows:
- “Food”: articles used for food or drink for man or other animals, and articles used for components of any such article.
- “Conventional food”: any food that is not a dietary supplement.
- “Dietary supplement”: products intended for ingestion to supplement the diet, including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary substances.
- “Cosmetics”: articles intended to be rubbed, poured, sprinkled, or sprayed or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
- “Drugs”: including biologics are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and affect the structure or function of the body.
Exceptions to IND requirements have been considered by the FDA for a number of years and, while FDA stayed prior guidance allowing clinical investigations of conventional food, under the new rule FDA expects to resolve issues concerning guidance.
To qualify for the “self-determined exemption”, there are some important considerations, including:
- Route of Administration: This requirement ensures that the studies evaluate the use of products that are administered in the same way as the currently marketed products. For example, products for oral ingestion could not be studied to be administered topically or transmucosally. Similarly, a cosmetic applied to the skin could not be studied for administration subcutaneously, intravenously, or intramuscularly.
- No vulnerable populations: The self-determined exemption would not apply to a study of subjects with compromised immune systems or serious or life-threatening diseases or conditions.
- Age Restrictions: No subjects less than 12 months of age or pregnant or lactating women.
- Ordinary conditions of use: The product would have to be used in ordinary conditions, including dose, daily intake, formulation, and duration.
The FDA can employ the “FDA-determined exemption” where one or more of the health, safety, and welfare criteria are not met.
The FDA Centers frequently receive inquiries regarding studies to evaluate a drug use of a food or cosmetic and recognize that there are multiple legitimate and beneficial reasons for conducting a clinical study. As the FDA restructures its oversight of the food industry with the creation of the Human Foods Program combining FDA Centers and functions, heightened interest by industry and academia and influx of significant government funding ensures that an apple a day may, one day, be by prescription.
There is time still to comment on the proposed rule to address important questions, such as scope and exclusivity.
Clark Hill is ready to assist with any questions about the impact of this proposed rule or submitting comments to the FDA. For further information, please contact the author, Michael A. Walsh. at mwalsh@clarkhill.com
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