Which of the following is NOT within the regulatory scope of the FDA?

• A. Medical devices
• B. Food safety
• C. Health insurance policies
• D. Tobacco products

Answer: (C)

The correct choice indicates that health insurance policies are not within the regulatory scope of the FDA. The FDA, or Food and Drug Administration, is primarily focused on protecting public health by regulating food safety, medical devices, human and veterinary drugs, vaccines, and tobacco products. These regulations cover a wide range of areas involving consumer protection from unsafe products or practices associated with these categories.

Health insurance policies, on the other hand, fall under the purview of other regulatory bodies, such as the Centers for Medicare & Medicaid Services (CMS) or state insurance departments. The regulation of health insurance involves different aspects, including coverage options, pricing, and consumer rights, which are distinct from the FDA's focus on product safety and efficacy.

Understanding the roles of various regulatory agencies helps clarify why health insurance policies are outside the FDA's jurisdiction while the other options—medical devices, food safety, and tobacco products—are all subjects of FDA oversight and regulation.