IBSPOT.com Inc. – FDA Warning Letter, Oct 1, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to IBSPOT.com Inc. on October 27, 2025, regarding the distribution of its "Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches". The FDA found these products to be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as both unapproved new drugs and misbranded drugs. Although no traditional inspection dates were cited, the FDA purchased and analyzed the products through the company"s website.

The primary violations include the products being unapproved new drugs under section 505(a) of the FD&C Act, as they are intended for therapeutic use (e.g., motion sickness, nausea, dizziness) but lack the necessary FDA approval for safety and effectiveness. Additionally, the products are misbranded under section 502(a) of the FD&C Act because laboratory analysis confirmed the presence of active ingredients, including diphenhydramine, diphenhydramine N-oxide, and diclofenac, which were not disclosed on their labels. This omission is considered false and misleading, preventing consumers from making informed decisions.

IBSPOT.com Inc. is required to respond to the FDA within fifteen working days of receiving the letter. The response must detail specific corrective actions taken to address these violations, explain steps to prevent recurrence, and include supporting documentation. If the company believes its products comply with the FD&C Act, it must provide reasoning and supporting information.