FDA WARNING_LETTER - Body, Mind & Soul, Inc.

The FDA issued a Warning Letter to Body, Mind & Soul, Inc. regarding their Celluderm device, marketed in the United States. The FDA determined the Celluderm is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

During an inspection of the contract manufacturer, Innovative Med Inc., and a review of Body, Mind & Soul's website and manuals, the FDA found the Celluderm, while appearing to be a therapeutic massager (21 CFR 890.5660), is marketed for unapproved uses. These uses include stimulating the lymphatic system, reducing congestion, breaking up fat, boosting the immune system, reducing water retention/edema, and relieving fibromyalgia, restless legs, headaches, and breast cysts.

These new intended uses exceed the exemption limitations in 21 CFR 890.9, making the Celluderm adulterated under section 501(f)(1)(B) of the Act because it lacks required premarket approval (PMA) or an investigational device exemption. It is also misbranded under section 502(o) of the Act for not having a 510(k) premarket notification.

Furthermore, Body, Mind & Soul has not fulfilled annual establishment registration and device listing requirements for fiscal year 2013, as mandated by section 510 of the Act, rendering