The U.S. Food and Drug Administration (FDA) has issued an Untitled Letter to Viatris Specialty LLC, stating that a direct-to-consumer (DTC) promotional video for TOBI® PODHALER® (tobramycin inhalation powder) contains false or misleading claims regarding the product's use. According to the FDA, the promotional material misbrands the drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The regulatory action relates to a patient testimonial video titled "Jax's Experience with the TOBI PODHALER", which includes statements suggesting that the medicine can be conveniently administered "in the car," "while running out of the door," or "on the way to school." FDA concluded that these claims create the misleading impression that the inhalation therapy can be used virtually anywhere without concern for proper preparation or handling.
According to the agency, the FDA-approved Instructions for Use (IFU) require several important preparation steps before administration. These include washing and drying hands, opening and assembling the inhaler correctly, placing the mouthpiece on a clean, dry surface, inspecting each capsule after inhalation, and repeating the inhalation process until all four capsules comprising a full dose have been used.
The FDA also emphasized that TOBI Podhaler capsules must be protected from moisture by removing only one capsule at a time from the blister packaging immediately before use and by storing both the capsules and inhaler in a dry place. According to the agency, failure to follow these instructions could result in incomplete delivery of the medication and administration of a suboptimal dose.
While acknowledging that the promotional video included certain instructions regarding product use, the FDA stated that these details were insufficient to correct the overall misleading impression created by the claims highlighting unrestricted portability and convenience.
As a result, the FDA concluded that the promotional communication misbrands TOBI Podhaler and requested that Viatris immediately discontinue or correct any misleading promotional materials. The agency also instructed the company to submit a written response within 15 working days, outlining corrective actions, identifying similar promotional communications, and explaining its plan to discontinue or revise such materials.
The FDA further noted that the issues identified in the letter may not represent all potential regulatory concerns and reminded the company of its responsibility to ensure that all promotional materials comply with applicable FDA regulations governing prescription drug advertising.
The Untitled Letter was signed by Qumerunnisa Syed, PharmD, Regulatory Review Officer, and Samuel Skariah, PharmD, RAC, Team Leader, within the FDA's Office of Prescription Drug Promotion, and was electronically issued on July 13, 2026.
