No, Ganoderma lucidum, also known as reishi mushroom, is not FDA approved as a drug or dietary supplement.
The FDA regulates drugs and supplements differently.
- Drugs: The FDA must approve drugs for safety and effectiveness before they can be marketed in the United States.
- Dietary supplements: The FDA does not approve dietary supplements before they are marketed. However, the FDA does have regulations in place for dietary supplements, such as requiring manufacturers to submit a New Dietary Ingredient (NDI) notification to the FDA before marketing a new dietary ingredient.
While Ganoderma lucidum is often marketed as a dietary supplement, it's important to understand that the FDA has not evaluated its safety or effectiveness for any specific health claims.
