FDA WARNING_LETTER - vedame oils llc

On July 18, 2017, the FDA issued a Warning Letter to Vedame Oils, L.L.C. dba UMA Oils, following a May 2017 review of their website, umaoils.com. The FDA determined that products such as Deep Nourish Extreme Dryness Treatment, Total Rejuvenation Night Face Oil, Deeply Clarifying Face Mask, and Deep Clarifying Blemish Spot Treatment are marketed with claims that establish them as unapproved new drugs. These claims indicate the products are intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the human body, violating sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. Since the products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the Act. Introducing these unapproved new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. The firm is required to take prompt action to correct all violations, review all product labeling, and notify the FDA in writing within fifteen working days of the specific steps taken to correct and prevent recurrence. Failure to comply may result in enforcement actions, including injunctions and product seizure.