FDA WARNING_LETTER - DRF, LLC - March 31, 2021

The FDA issued a Warning Letter to Dr. Farrah Agustin-Bunch following a review of her websites (doctorfarrah.com, drfarrah.online) and Instagram in February and March 2021. The agency determined that the products Boston C, Mega-Dose Vitamin C, and Pixie Dust Magnesium are marketed with claims indicating their intent for the cure, mitigation, treatment, or prevention of disease, thereby classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Additionally, the products are misbranded under section 502(f)(1) because they lack adequate directions for use, as the conditions they claim to treat are not suitable for self-diagnosis or treatment by a layperson. The introduction of these misbranded drugs into interstate commerce violates section 301(a). The FDA requires a written response within 15 working days detailing specific corrective actions and steps to prevent recurrence. Failure to comply may result in legal action, including product seizure and injunction.