FDA WARNING_LETTER - Prismic Light International, aka Sandent Co. - May 07, 2008

The FDA issued a Warning Letter to Prismic Light International (aka Sandent Co.) following an inspection on May 6-7, 2008, and a review of their product labels and websites. The agency determined that the firm's CELL RENEW and CELL RENEW Essential Silica products are unapproved new drugs under Section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act. This classification is based on therapeutic claims made on their websites and product labels, suggesting uses for disease cure, mitigation, treatment, or prevention, such as supporting chemotherapy patients, allergy relief, tissue repair for various conditions, and anti-inflammatory effects. As new drugs, they require prior FDA approval under Section 505(a).

Furthermore, the products are misbranded under Section 502(f)(1) because their labeling lacks adequate directions for use. The CELL RENEW product is also improperly marketed as a dietary supplement for topical and non-ingested uses, which violates Section 201(ff)(2)(A) as dietary supplements are limited to ingested products. Additionally, during the inspection, unlabeled shipping cartons of "CELLAID" for export to China were observed, indicating a failure to comply with export requirements under Section 801(e) of the Act. The firm is required to take prompt corrective action, notify the FDA within 15 working days with a detailed plan and documentation, and address all identified violations to prevent legal action, including seizure and injunction.