Blog Post

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

MoFo Life Sciences

25 Feb 2022

Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S. Food and Drug Administration (FDA).  Because the suit was brought pursuant to the private right of action provided by the Lanham Act, the case also called into question whether such a claim was precluded by the authority of the FDA (or U.S. Federal Trade Commission (FTC)) over the product’s labeling.  In particular, the case addressed whether fluoride is most appropriately classified as a drug or dietary supplement and whether product labeling, including the use of “Rx” in labeling for a purported dietary supplement is misleading. 

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