Fluoride Supplement Manufacturer Forced To Address Misleading Labeling Allegations

• Published date: 01 March 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Morrison & Foerster LLP
• Author: Ms Brigid DeCoursey Bondoc, Zachary Fuchs and Rachel Park

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.

This is not the first case to address the propriety of labeling for 'prescription' dietary supplements, and a prior case addressing prenatal vitamins reached the opposite result, finding that the Rx mark was not misleading. While the cases are factually distinct, strident competition in the dietary supplement industry may lead other manufacturers to edge out the competition by implying that their products have undergone the rigorous review for prescription drugs or are eligible for medical coverage or reimbursement. Without a definitive statement from the FDA regarding whether such claims are false or misleading, we expect to see more unfair competition and false advertising cases like this one.

Background

Method Pharmaceuticals LLC and H-2 Pharma LLC produce fluoride products. Because excessive consumption of fluoride supplements may cause tooth damage, some manufacturers, like Method, require prescriptions for their fluoride supplement products. H-2, on the other hand, offers its fluoride products either by prescription or by general purchase as dietary supplements. The FDA has not yet determined if H-2's fluoride supplements should be treated as drugs or as dietary supplements,¹ an important distinction, given the costs of complying with myriad drug regulations in the United States.

Method claimed that: (1) H-2's use of the 'Rx' mark on its fluoride products misleads consumers to believe they are prescription drugs; and (2) that H-2 uses the Rx mark to have its products linked to Method's prescription drugs in pharmaceutical databases that track substitute drugs for use by physicians, effectively pricing them out of the market. In an order filed on...