FDA WARNING_LETTER - Slim Beauty USA - December 09, 2013

On December 9, 2013, the FDA inspected Slim Beauty USA and reviewed its website, concluding that "Dr. Ming's Chinese Capsule," "Magic Slim," and "Dream Body Slimming Capsule" are unapproved new drugs and misbranded. These products, marketed as dietary supplements, were found to contain undeclared sibutramine, which was withdrawn from the market due to increased risks of heart attack and stroke. "Dr. Ming's Chinese Capsule" and "Magic Slim" also contained undeclared phenolphthalein, reclassified as "not generally recognized as safe and effective."

The FDA cited violations of sections 505(a), 502, and 503 of the FDCA, stating the products are new drugs under section 201(p) because they are not generally recognized as safe and effective. Their introduction into interstate commerce violates section 301(d) and (a). The products are misbranded under section 502(f)(1) for lacking adequate directions for use, 502(a) for false/misleading labeling by not revealing undeclared ingredients, and 502(f)(2) for lacking adequate warnings. They are also misbranded under section 502(j) for being dangerous when used as recommended.

Slim Beauty USA was instructed to take prompt action to correct all violations and prevent recurrence. Failure to