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.

Josh Long, Associate editorial director, Natural Products Insider

February 25, 2014

1 Min Read
FDA draws line in sand on inflammation claims

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.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like