New Sun Inc. – FDA Warning Letter, Oct 29, 2021

The FDA conducted an inspection of New Sun's dietary supplement and cosmetics manufacturing facility in Hendersonville, NC, from October 28-29, 2021, reviewing product labels, brochures, and the website www.mynewsun.com. The Agency determined that New Sun markets various products, including CBD-containing items, with claims establishing them as unapproved new drugs under sections 201(g)(1) and 201(p) of the FD&C Act, intended for disease treatment, cure, mitigation, or prevention. A specific concern was the marketing of Advanced CBD Oil as safe for children without FDA evaluation. Furthermore, New Sun's CBD products are illegally marketed as dietary supplements, as CBD is excluded from the dietary supplement definition under section 201(ff) of the Act. Several products, including Advanced Liver Plus and various CBD oils, are also deemed misbranded under section 502(f)(1) because they lack adequate directions for use, being intended for conditions requiring professional supervision (21 CFR 201.5). The introduction of these unapproved and misbranded drugs into interstate commerce violates sections 301(d), 505(a), and 301(a) of the Act. The FDA also noted a misleading website claim about operating in an "FDA approved facility." New Sun must respond within 15 working days with corrective actions to prevent recurrence, or face potential legal action like seizure or injunction.