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July 14, 2014
In a 10-page document early this year that updated its guidance from 2009, FDA distinguished liquid dietary supplements from beverages. The agency cited a variety of factors that are relevant in reviewing whether a product is a conventional food or supplement, and no one factor is typically the sole determinant. The possible exception is representing a product as a conventional beverage such as calling it “bottled water," a term that is associated with a standard food regulation.
FDA’s guidance is non-binding, although it represents the agency’s thinking on a topic. Fortunately, FDA may give a manufacturer a civil heads-up if it disagrees with a firm’s classification of a product as a supplement. That’s because a manufacturer must notify FDA 30 days before marketing a supplement with a specific claim of being able to treat the structure or function of the human body.
Since FDA issued its most recent draft guidance, the agency has issued at least one additional warning letter to a company for mislabeling products as supplements. In a March 27, 2014 letter, FDA cited the company’s description of its products as beverages on the cans' information panels and referenced the company's website, which refers to its products as the "#1 relaxation beverage" and "the most potent relaxation drink."
Read the full article “Supplements v. Conventional Beverages: Toeing the Line" in INSIDER’s Functional Foods Digital Issue.
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.
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.
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