FDA Issues Warning Letter to Vacation, Inc. Over Sunscreen Claims

The U.S. Food and Drug Administration (FDA) has raised concerns regarding Vacation, Inc. and its line of sunscreen products known as “Classic Whip Sunscreens.” Following an in-depth review of the product labels and online representations, the FDA concluded that these sunscreen formulations qualify as "drugs" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Understanding the FDA’s Findings

According to the FDA, the Classic Whip Sunscreens are classified as drugs because they are aimed at preventing or treating health-related issues such as sunburn, skin cancer, and skin aging caused by sun exposure. This classification is supported by various claims found across the product labels, website, and social media channels.

Key Findings from FDA Review:

• The products claim to “help prevent sunburn” and “decrease the risk of skin cancer and early skin aging” when used as directed.
• The FDA cited specific text from the product labels and marketing materials as evidence of intended drug use.

Highlighted Claims Include:

• Vacation Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE
• Vacation Classic WHIP GLOW BROAD SPECTRUM SPF 30 SHIMMER SUNSCREEN MOUSSE

Quotes from product descriptions that prompted scrutiny:

• “A decadent dessert for the skin that we like to call Vacation Classic Whip.”
• “Lightweight, ‘dessert-inspired’ sunscreen you know and love.”

The FDA noted that these representations suggest the products are intended for OTC (over-the-counter) use, which carries specific regulatory obligations.

Comparison with Similar Warnings

This isn’t the first time the FDA has addressed marketing claims in the sunscreen industry. Just last week, a similar warning was issued to Supergoop! for potentially misleading claims about their sunscreen. Companies are increasingly being scrutinized for how they present their products, particularly when health claims are involved.

The Importance of Compliance

The FDA emphasizes the need for compliance with regulations governing over-the-counter drug products. This includes:

• Clear labeling
• Avoiding misleading health claims
• Ensuring that marketing materials do not imply unapproved uses

For consumers, the distinction between cosmetic products and drug products is crucial, as it affects safety standards and efficacy regulations. A cosmetic may claim to improve skin appearance but should not imply health benefits unless proven and authorized by the FDA.

Conclusion

The FDA’s recent warning to Vacation, Inc. serves as a reminder to all sunscreen manufacturers about the importance of adherence to regulatory requirements. Companies must ensure their marketing strategies align with what is legally permissible and scientifically verifiable. For consumers looking to make informed choices about sun protection, understanding the distinctions between drug and cosmetic products is paramount.

For further details, visit the FDA’s official site on sunscreen regulations.

Stay informed and ensure your sun protection choices meet health standards for effective safety and efficacy.