Does this Draft Guidance change how FDA regulates dietary supplements such as StemEnhance?
No – The Draft Guidance provides FDA’s proposed definition of CAM products (Complimentary and Alternative Medicine Products) and explains how these products, depending on how they are labeled and marketed and for what specific intended uses, will fall into existing FDA regulatory categories such as “drugs,” “biologics,” “devices” or “foods” (which include “dietary supplements”).
Related Questions
- What do regulatory agencies, such as the FDA and FSA advise with regard to evaluating and buying dietary supplements?
- What is the FDAs role in regulating dietary supplements versus the manufacturers responsibility for marketing them?
- Does this Draft Guidance change how FDA regulates dietary supplements such as StemEnhance?