FDA WARNING_LETTER - Napa Valley Bioscience

The FDA issued a Warning Letter to Napa Valley Bioscience regarding their product, Sunsafe Rx, sold on www.sunsaferx.com. The FDA reviewed the website, product label, and labeling in March 2018 and determined that Sunsafe Rx is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because its claims on the website, label, and labeling indicate it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such claims include "protects your skin and eyes from the sun," "BROAD SPECTRUM PROTECTION," "RELIEF FOR PHOTOSENSITIVITIES," "can help prevent or treat solar keratosis," and "defend your skin and eyes from sun damage."

Sunsafe Rx is considered a "new drug" because it is not generally recognized as safe and effective for its claimed uses. Introducing a new drug into interstate commerce without prior FDA approval violates the Act. Furthermore, the product is misbranded because it lacks adequate directions for use by a layperson, as it is intended for conditions like actinic keratosis, photodermatoses, photosensitivities, and macular degeneration, which require supervision by a licensed practitioner.

Napa Valley Bioscience must take prompt action to correct all violations, including reviewing all product labeling to ensure compliance. Failure to do so may result in enforcement actions such as injunctions