FDA Inflammation Claims

FDA Draws Line in Sand on Inflammation Claims

FDA may find that a claim is unlawful even if a product doesn't explicitly reference the more than 100 diseases that are characterized by excess inflammation such as arthritis and Crohn's Disease.

Marketers of dietary supplements to fight inflammation may be unknowingly violating FDA's prohibition against disease claims. Although making explicit disease claims is clearly unlawful, FDA may find that a claim is off limits even if a statement doesn't explicitly reference diseases that are characterized by excess inflammation.

FDA has emphasized that broad statements such as "supports healthy inflammation response" are unauthorized.  Inflammation claims must be limited in scope to non-disease states such as a statement that a dietary supplement is intended to help fight foot inflammation after running a marathon. FDA made this clear during a webinar hosted last year by VIRGO and the Council for Responsible Nutrition (CRN).

Although it is well known supplement firms cannot claim to treat, cure, prevent, diagnose or mitigate a disease, FDA said some businesses are under the mistaken impression that using other verbs like "promote," "regulate" and "support" automatically render a claim lawful. That is simply not true. Again, FDA will examine whether a statement is qualified and limited in scope to a non-disease state.

Finally, the structure/function claim that a supplement firm submits to FDA is not the only evidence the agency considers in determining whether a claim is unlawful. FDA also will review other materials, such as brochures, websites and social media.

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