Guidance Draft FAQs

How is a “guidance” different from a regulation or a law?

First, a “guidance” document is by definition, neither legally binding, nor does it change or create laws or regulations. Guidances, like the one in question, are usually issued to help explain how a law or laws are applied. In this case, the guidance clarifies how products used in CAM, such as foods and dietary supplements, are regulated under different provisions or statutes depending on their intended use and claims. Whether finalized or not, the draft guidance will not change current laws and regulations, such as the Dietary Supplement Health and Education Act.