FDA WARNING_LETTER - GC America, Inc. - July 13, 2012

During a June 27 - July 13, 2012, inspection of GC America, Inc. in Alsip, Illinois, the FDA determined the firm is marketing MI Paste, MI Paste Plus, and MI Varnish devices without appropriate marketing approval, violating the Federal Food, Drug and Cosmetic Act.

While these devices received 510(k) clearance for specific indications (e.g., cleaning, polishing, managing tooth sensitivity), the firm's product brochures and indication pads make additional claims. These include remineralization, treating dry mouth (xerostomia), treating Sjogren's syndrome, and penetrating/remineralizing sub-surface lesions. These claims represent expanded intended uses, constituting major changes or modifications under 21 CFR 807.81(a)(3)(ii).

Consequently, the devices are adulterated under Section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption. They are also misbranded under Section 502(o) for failing to notify the FDA of intent to introduce these devices with new intended uses, as required by Section 510(k).

GC America, Inc. must immediately cease marketing and disseminating labeling/promotional materials with these unapproved claims. They cannot market the devices for any intended use outside their 510(k) clearance without