SW Legal studies in Business

No Private Cause of Action to Enforce Food, Drug and Cosmetic Act.

Trial court dismissed a suit against the maker of a cold and flu product that contained vitamin C. Plaintiffs’ claims that the alleged benefits of vitamin C were unproven and so violated the Food, Drug and Cosmetic Act were rejected as there is no such private cause of action.


Consumer Protection

Key Words

Drug, Advertising, Effectiveness, Class Action

C A S E   S U M M A R Y

Plaintiffs sued Procter & Gamble (P&G) for two “cold and flu symptom relief” products that contained vitamin C. They contended the products were developed to capitalize on a common misconception that vitamin C is useful for treating or preventing the common cold. Plaintiffs contend the products are ineffective and that advertising is false and misleading. They claim violation of state consumer statutes and violation of the Food Drug and Cosmetic Act (FDCA). P&G moved to dismiss the class action suit.


Motion granted. There is no private right of action to enforce the FDCA. Not only is a private party precluded from bringing suit to enforce the provisions of the FDCA, they may not use other federal statutes or state unfair competition laws as a way to bring a private cause of action that is based on violations of the FDCA. A state-law claim does not exist where the claim is in substance a claim for violating the FDCA, that is, when the state claim would not exist if the FDCA did not exist. The main purpose of the advertising restrictions in the FDCA and its regulations is not to protect consumers from deceptive advertising, but to further the FDCA’s underlying goal of ensuring drug safety. If plaintiffs can identify specific representations by defendants that are literally false, misleading, or contain material omissions, the claims are actionable under state consumer fraud laws and not precluded by the FDCA. Generally, to prevail on a claim that a defendant misrepresented the effectiveness of its product under state law, rather than stating a claim under the FDCA, plaintiffs must show that the misrepresentations are false or misleading, not merely that they are unsubstantiated by acceptable tests or other proof. Consumers’ claims that they purchased certain cold medicines based on manufacturer’s misleading advertisements as to efficacy of vitamin C in the medicine, rather than cheaper alternatives, were insufficient to plead ascertainable loss.


Loreto v. Procter & Gamble, ---F.Supp.2d--- (2010 WL 3471752, S.D. Ohio, 2010)

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