It is true that many people are confused about the difference between laws and regulations. Laws and regulations are rules. But, they differ in how they came into being. The difference between laws and regulations is:

Laws are enacted by a governing body, in the U.S. An elected governing body is called Congress. Similar elected bodies enact laws in other countries. Enacted laws are enforceable in court. The Food, Drug, and Cosmetic Act (FD&CA)is an example of an enacted law.

Regulations are laws made by agencies. Agency-made laws are called regulations. As with enacted laws, agency-made laws, and regulations, are enforceable in court. Regulations made by the FDA are examples of agency-made laws.

Enacted laws and agency-made laws, which are called regulations, are similar in that they state legal requirements and are enforceable in court. Regulations are limited in this way:

An agency can create regulations only if an enacted law authorizes it to do so. A law authorizing an agency to make regulations is called a “Rules Enabling Statute.” (A statute is an enacted law that has been given a number and published in an official book of statutes, or “codified.”) An agency can create regulations only to implement or enforce the enacted law.

A section of the enacted law, FD&CA, authorized the creation of the FDA and authorized the agency to make regulations to carry out the FD&CA. FDA cannot at its own discretion broaden, or narrow, the FD&CA.

In contrast to regulations, FDA guidelines are not laws and are not in themselves enforceable in court. Similarly, standards, which are collective works setting forth specifications and methods for achieving them, by organizations having interest and expertise in the subject area, are not in themselves, legally enforceable. Sometimes, however, a standard is “incorporated by reference” into an enacted law or regulation thereby making that standard a part of the law.