A proposed class action alleges Ricola Nasal Care Max Strength menthol lozenges are mislabeled given that menthol offers no decongestant benefits.
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The 21-page suit contends that although consumers who view the product’s front label will expect the lozenges to be able to reduce symptoms of congestion and stuffiness, the product’s packaging is misleading “for several reasons.”
For one, the case says, in the “Uses” section on the back label, defendant Ricola USA concedes that the lozenges are able to only temporarily relieve “minor mouth and throat irritation” and not nasal symptoms. Second, the lawsuit shares, menthol provides no relief for nasal symptoms, “which is why the FDA did not authorize [Ricola] to make these types of claims.”
“Studies have consistently demonstrated that though menthol stimulates cold receptors in nasal mucosa to create an increased sensation of airflow, it is incapable of any nasal decongestant action,” the complaint specifies. “No evidence was found in support of any nasal decongestant action for menthol.”
Third, the lawsuit says that the Ricola drops at issue do not contain any nasal decongestant active ingredients, whether oral or topical. As such, labeling the lozenges as providing “Nasal Care” is false and misleading and renders the Ricola product misbranded, the complaint alleges.
From there, the case argues that describing the menthol Ricola lozenges as “max strength” and “extra strength menthol” is similarly misleading, namely because the product contains less menthol than the maximum 20 mg limit allowed by the FDA. Per the suit, each lozenge contains just 15.3 mg of menthol.
Overall, there are no “credible or accepted controlled scientific studies or reports” that indicate 15.3 mg of menthol provides a greater therapeutic benefit than a lozenge containing even 10 mg of menthol, the complaint contests.
The filing says that there exists no justification for Ricola USA to claim that, from a therapeutic perspective, the 15.3 mg of menthol in the lozenges amounts to the product’s potency being superior to a lozenge containing less than that, namely due to how the FDA has evaluated the dosages of menthol lozenges.
“When the FDA evaluated the dosages for menthol lozenges, it only relied on studies of 9 mg menthol lozenges, not 20 mg, the maximum amount allowed,” the suit states. “However, because the amount of menthol that would be fatal was significantly higher at 2 g, it allowed a maximum concentration of 20 mg, but not based on a showing this concentration was more effective or potent.”
The lawsuit looks to cover all consumers in Florida who bought Ricola “Nasal Care” menthol lozenges in the state during the applicable statute of limitations period.
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