FDA WARNING_LETTER - CV7 Holdings LLC

On May 18, 2018, the FDA issued a Warning Letter to CV7 Holdings, LLC, regarding their product Soleil Sun Protection, sold on www.soleilprotection.com. The FDA reviewed the website and product label in March 2018.

The FDA determined that Soleil Sun Protection is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. The product is deemed a drug due to claims on the website and product label indicating its intent for use in diagnosing, curing, mitigating, treating, or preventing disease. Examples of such claims include "water resistant sunblock with a mix of vitamins and antioxidants," "protect you from ultraviolet rays," "prevent your premature aging," "prevents DNA damage," "Certified skin protection from sun rays," "Reduces UV-induced cell damage," "Blocks UV radiation-induced immune suppression," "heals sunburns," "Antioxidant qualities protect from UV damage," "Protects Against Eye Disorders," "Reduces Diabetes Risk," "Avoid severe sunburn," "Sun protection," "UV-defense," and "aids in preventing sun damage."

As a "new drug," Soleil Sun Protection lacks FDA approval based on scientific data demonstrating safety and effectiveness, violating sections 301(d) and 505(a) of the Act. Furthermore, the product is misbranded under section 502(f)(1) because it lacks