Psyched Wellness Ltd. – FDA Warning Letter, Sep 1, 2026

On September 29, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to the Canadian firm Psyched Wellness Ltd. following a review of the company"s website conducted in May 2026. The FDA found that the company"s dietary supplement products—Calm, Calmer, and Santa—are in violation of the Federal Food, Drug, and Cosmetic Act. The primary issue is the inclusion of Amanita muscaria extract as a dietary ingredient. The FDA classifies this extract as a "new dietary ingredient" because there is no evidence of it being marketed in the United States prior to October 15, 1994. Under the current regulatory framework, such products are considered adulterated if there is insufficient information to ensure they do not pose a significant or unreasonable risk of injury or illness. The FDA concluded that the company provided inadequate safety data, and noted that existing information on the mushroom extract raises serious safety concerns. Psyched Wellness Ltd. is required to submit a written response within 15 working days detailing the corrective actions taken to address these violations and prevent their recurrence. Failure to comply with these requirements may lead to legal enforcement, including product seizures or injunctions.