February 25, 2022 - FDA, Healthcare, Pharma, Regulatory, United States

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

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 February 3, 2022, Chief Judge Emily C. Marks found that all but one of the five claims brought by Method could go forward, as these claims adequately allege a false representation and do not circumvent FDA’s regulatory authority.

Use of “Rx” on Labeling

Method argued that use of an “Rx” mark on non-prescription products is likely to be interpreted as misleading, and insufficiently distinguished from the official “Rx only” or “R only” labeling required for prescription products.  Judge Marks found H-2’s distinction between “Rx” and “Rx only” insufficient because H-2 marks its products with “Rx” regardless of whether they actually are prescription products.  Judge Marks wrote, “Indeed, if H-2 is correct that FDA regulations do require all prescription drugs to be marked with ‘Rx Only,’ that it marks its products with the similar ‘Rx’ appears to make it more likely that the market would be confused, not less.”  Judge Marks also pointed to allegations that H-2 knowingly omitted the customary disclaimer that products are not FDA approved, painting “a broader picture of H-2’s alleged misrepresentations than a mere ‘Rx’ on its labels.”

There have been a few other recent cases touching on the use of “Rx” and “prescription only” labels for non-drug products.  For example, the Northern District of Illinois in Lupinetti v. Exeltis considered prenatal vitamins labeled with the “Rx” mark or phrase “prescription only” and the allegation that this labeling was intended to cause government coverage under Medicaid.[2]  The court rejected that claim, finding that it was objectively reasonable for the prenatal vitamin manufacturers to believe they could label their prenatal vitamins as “prescription only.”  In that case, the manufacturers’ “prescription only” labeling and statements were based on Centers for Medicare and Medicaid Services (CMS) guidance explaining that “prescription prenatal vitamins continue to meet the definition of a covered outpatient drug and are rebate-eligible” and issuance of a “covered outpatient drug” code for prescription prenatal vitamins.[3]

FDCA Implications: Claim Preclusion and Federal Preemption

Method also highlights apparent tension between Federal Food, Drug, and Cosmetic Act (FDCA) and the Lanham Act.  As the opinion explains, the FDCA proscribes misbranding of food and drugs and vests exclusive enforcement authority in the FDA, while the Lanham Act allows competitors to sue each other for false or misleading product descriptions.  It is clear from the Supreme Court’s decision in POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 120-21 (2014), that the FDCA does not preclude lawsuits concerning misleading labels between private competitors when it comes to food and beverage products.  Since then, courts across the country have grappled with whether Pom Wonderful extends to dietary supplements.[4]  

Method reaches a reasonable conclusion: if the Lanham Act claim does not require courts to contradict the FDA or make a determination committed to the FDA’s sole discretion, then it is permissible.  That rule allows companies to limit unfair competition, but respects the FDA’s authority and expertise with respect to safety.

Along those lines, Method is relevant to the larger topic of FDA preemption of state law labeling claims.  This is an important issue because labeling claims are influential in driving consumer behavior.[5]  In this case, the court weighed whether private lawsuits were foreclosed by the FDCA but in other cases, courts have resolved conflicts between the FDA and state regulators enforcing state laws.[6]  A major theme in all of these cases is determining the proper role for the FDA.  On one hand, the FDCA vests sole enforcement authority for its regulations in the FDA for good reason—not only because of the FDA’s expertise, but also because complex national issues require dynamic federal solutions.  On the other hand, the FDA cannot possibly respond to every complaint from the industry regarding unfair or misleading labeling.  Moreover, reading the FDCA and its preemption provisions too broadly could jeopardize other vehicles for limiting misbranding and false advertising.

 


[1] Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, 2:20-CV-753-ECM (M.D. Ala. February 3, 2022).

[2] See Lupinetti v. Exeltis USA Inc., 2021 WL 5407424 (N.D. Ill Nov. 19, 2021).

[3] CMS, Release No. 159 (Dec. 28, 2011). 

[4] The Eleventh Circuit, which was binding on the Method court, has held that the FDCA does not preclude labeling claims under the Lanham Act.  Belcher Pharmaceuticals, LLC v. Hospira, Inc., 1 F.4th 1374, 1380-81 (11th Cir. 2021).  And the Ninth Circuit has reached a similar conclusion in ThermoLife Intern., LLC v. Gaspari Nutrition Inc., 648 Fed. App’x 609, 612 (9th Cir. 2016).  But in Amarin Pharma, Inc. v. International Trade Commission, 923 F.3d 959, 968-69 (Fed. Cir. 2019), the Federal Circuit held that the FDCA precluded that plaintiff’s particular Lanham Act claims.

[5] See Amanda Berhaupt-Glickstein, Neal H. Hooker, & William K. Hallman, Qualified Health Claim Language affects Purchase Intentions for Green Tea Products in the United States, 11 Nutrients 924 (Apr. 2019); Johann Steinhauser, Meike Janssen, & Ulrich Hamm, Who Buys Products With Nutrition and Health Claims? A Purchase Simulation with Eye Tracking on the Influence of Consumers’ Nutrition Knowledge and Health Motivation, 11 Nutrients 2199 (Sept. 2019).

[6] See, e.g., Johnson & Johnson v. Fitch ex rel. State, 315 So. 3d 1017 (Miss. 2021), cert. denied, 142 S. Ct. 732 (2021) (assessing whether the FDCA preempts labeling claims under the Mississippi Consumer Protection Act). Morrison & Foerster filed an amicus curiae brief on behalf of former FDA officials in support of Johnson & Johnson’s petition for certiorari.