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Monday, February 22, 2021 FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.”  In general, a dietary supplement is allowed to make claims about having an effect on the “structure” or a “function” of the human body.  If FDA finds that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, it will be deemed a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  FDA routinely takes enforcement action against su...

On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted...

Following a series of Warning Letters issued throughout 2020 related to recalls due to allergen labelling errors, the U.S. Food and Drug Administration (FDA) recently issued a...