A federal court in Ohio has dismissed with prejudice a putative class action alleging that promotions for over-the-counter (OTC) cold- and flu-symptom relief products with vitamin C were false or misleading and violated state consumer protection laws. Loreto v. The Procter & Gamble Co., No. 1:09-cv-815 (U.S. Dist. Ct., S.D. Ohio, W. Div., decided September 3, 2010).
The plaintiffs did not allege that the products were actually ineffective, but instead relied on a Food and Drug Administration (FDA) warning letter to the manufacturer stating that the products did not comply with the agency’s final monograph for OTC cold and cough drugs because they contained vitamin C. FDA apparently decided not to allow vitamin C to be added to these types of products because the data did not show that vitamin C alone “is unequivocally effective for the prevention or treatment of the ‘common cold’ although some data tended to favor effectiveness for the treatment of cold symptoms.” To obtain FDA recognition of its products as safe and effective for intended use and to sell the products in interstate commerce, the manufacturer was purportedly told that it was required to submit a “new drug” application and have FDA approve it.
Determining whether the plaintiffs had stated a claim upon which relief could be granted, the court emphasized that nothing in the warning letter or the complaint suggested that “the addition of vitamin C renders the other ingredients in the Products literally ineffective as ‘pain reliever/fever reducer, cough suppressant, nasal decongestant, and antihistamine.’” The court also observed that the plaintiffs failed to allege any ascertainable loss or that they “did not receive what they bargained for when they purchased the Products.” The court agreed with the defendant that the plaintiffs’ state law claims essentially sought to enforce the federal Food, Drug, and Cosmetic Act, which does not provide for a private right of action, to the extent that the plaintiffs were seeking damages for the company’s alleged failure to seek and obtain FDA approval before selling their products.