FDA WARNING_LETTER - New Sun, Inc.

The FDA issued a Warning Letter to New Sun after reviewing its website, www.newsun.net, and determining that three products—"New Sun Grape Seed Extract," "New Sun Super Sam (TOA Free Cat's Claw)," and "New Sun Yew/Olive Combination"—are promoted with therapeutic claims that cause them to be unapproved new drugs. The website features claims suggesting the products can cure, mitigate, treat, or prevent various diseases, including diabetic retinopathy, high blood pressure, inflammation, Lyme disease, cancer, HIV, diabetes, herpes, ulcers, and infections. These claims establish the products as drugs under 21 U.S.C. § 321(g)(1)(B). As they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under 21 U.S.C. § 321(p) and require prior FDA approval, which they lack (21 U.S.C. § 355(a)). Furthermore, the products are misbranded under 21 U.S.C. § 352(f)(1) because their labeling fails to bear adequate directions for use. New Sun is required to take prompt action to correct these violations, review all labeling and promotional materials, and notify the FDA within fifteen working days of the specific steps taken. Failure to comply may result in enforcement actions, including product seizure and injunctions.