FDA WARNING_LETTER - Vitapurity Corporation

The FDA issued a Warning Letter to VitaPurity.com after reviewing their website and determining that six products—"Citral," "Ellagic Ultra," "Lycopene 25," "Pacific Ocean Shark Cartilage," "Miracle Mushroom Blend," and "Buffered Vitamin C Crystals"—are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims, including numerous examples and testimonials related to cancer cure, mitigation, treatment, or prevention, establish their drug intent.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses. Marketing new drugs without prior FDA approval, as required by section 505(a), is illegal. Furthermore, the products are misbranded under section 502(f)(1) of the Act because their labeling lacks adequate directions for use.

The FDA noted that the listed violations are not exhaustive, as the website promoted these and other products for various disease treatments and prevention beyond cancer. VitaPurity is required to take prompt action to correct these violations, review all promotional materials, and ensure compliance with the Act. Failure to do so may result in enforcement actions, including product seizure and injunctions. A written response detailing corrective steps and timelines is required within fifteen working days.