The Food and Drug Administration (FDA) regulates drugs used to treat or modify a disease. Herbs and dietary supplements are exempt from regulation unless they make direct or indirect claims of therapeutic efficacy. Once such claims are made either the manufacturer must obtain FDA approval, remove the claim, or withdraw the product from market.


General requirement - The herb or dietary supplement must not claim to diagnose, mitigate, treat, cure or prevent a disease or class of diseases.


Specific cause for recall - If the herb or food supplement:

(1) claims to have an effect on a diseases or class of diseases.

(2) claims to have an effect on 1 or more signs or symptoms that are considered specific for 1 or more diseases

(3) claims to have an effect on an abnormal condition associated with a natural state or process if the condition can cause significant or permanent harm

(4) implies to have an effect on a disease directly or indirectly (see below)

(5) belongs to a class of products that is intended to diagnose, mitigate, treat, cure or prevent a disease

(6) is advertised as an alternative or substitute for a drug used to treat a disease

(7) augments a particular therapy or drug action

(8) has a role in the body's response to a disease or to a cause for a disease

(9) treats, prevents, or mitigates an adverse event associated with a therapy for a disease AND if the adverse event constitutes a disease

(10) in any way suggests an effect on a disease or group of diseases


Direct or indirect methods to imply an effect on a disease:

(1) in the name of the product

(2) through the use of symbols, pictures, vignettes or other visual means

(3) citation of a reference specifically mentioning therapy of a disease

(4) use of the term "disease" or "diseased"

(5) specific mention of ingredients as approved for use in preventing or treating a disease


To read more or access our algorithms and calculators, please log in or register.