FDA WARNING_LETTER - Vacation Inc. - March 05, 2025

The FDA issued a warning letter to Vacation Inc., located at 936 SW 1st Ave #888, Miami, FL, regarding their "Vacation® Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE" and "Vacation® Classic WHIP GLOW BROAD SPECTRUM SPF 30 SHIMMER SUNSCREEN MOUSSE." The inspection, conducted on March 5, 2025, revealed that these products are marketed as over-the-counter (OTC) drugs without FDA-approved applications, violating sections 505 and 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The main violations include misbranding under section 502(ee) due to non-compliance with section 505G, which governs the marketing of nonprescription drugs. Additionally, the products are misbranded under section 502(i)(1) because their packaging resembles food containers, potentially misleading consumers and increasing the risk of accidental ingestion.

The FDA requires Vacation Inc. to address these violations by investigating their causes and implementing corrective actions to prevent recurrence. The company must respond in writing within 15 working days, detailing the steps taken to correct the violations and prevent future issues. Failure to comply may result in legal actions, including product seizure and injunctions. The response should be sent to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the firm"s name and the identifier "706039."