Which of the following is NOT governed by the Food, Drug, and Cosmetic Act?

The correct choice highlights that nutraceuticals are not specifically governed by the Food, Drug, and Cosmetic Act (FDCA) in the same direct manner as other categories like medical foods, cosmetics, and dietary supplements.

The FDCA primarily regulates drugs, devices, and cosmetics, establishing standards for safety and efficacy. Medical foods fall under a specific category that addresses foods formulated for special dietary needs concerning medical conditions. Cosmetic products are regulated to ensure that they are safe for use and labeled properly, while dietary supplements are subjects of specific regulations that define their labeling and marketing, ensuring they are not falsely advertised and meet safety standards.

Nutraceuticals, however, do not have a clear regulatory definition under the FDCA. They are often considered a cross between a food and a drug but lack the rigorous approval processes typically associated with pharmaceuticals. This ambiguous classification leads to them being regulated more like dietary supplements or foods rather than as a distinct category under the FDCA. As a result, they experience less oversight in how they are marketed and sold compared to the other options listed.

This distinction makes clear why nutraceuticals do not fit neatly into the regulatory scope established by the FDCA compared to the other categories.