The FDA’s watchdogs are putting their language skills to use. Regulatory Focus reports that the regulator issued a Warning Letter to website owner Ramon Rosa for misbranding his products.
Rosa claimed his drugs could treat illnesses including cancer, ringworm, diabetes and arthritis, and the FDA says it has not approved these claims. What makes this Warning Letter different is that it is about materials written in Spanish.
RF notes that the majority of the FDA’s promotional monitoring focuses on English language promos, but that it has the authority to review Spanish-language materials if they are published in Puerto Rico—which is where Rosa is based.
