FDA WARNING_LETTER - H & L Jerch Sales, Inc. d/b/a Bell Lifestyle Products Inc - July 31, 2011

The FDA issued a Warning Letter to H & L Jerch Sales, Inc. (d.b.a. Bell Lifestyle Products Inc.) on August 10, 2011, following a review of their website, product catalog, and product label for "Nattokinase Heart Attack & Stroke Prevention." The FDA determined that "Heart Garlic Support Combo" and "Nattokinase Heart Attack & Stroke Prevention" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the FD&C Act, due to therapeutic claims indicating intent for diagnosis, cure, mitigation, treatment, or prevention of disease.

Specific therapeutic claims cited for "Nattokinase Heart Attack & Stroke Prevention" included preventing heart attacks and strokes, increasing blood flow, lowering blood pressure, and avoiding blood clots. Claims for "Heart Garlic Support Combo" included preventing heart attacks, strokes, arteriosclerosis, regulating cholesterol, and improving microcirculation, with a testimonial also referencing diabetes health problems.

The FDA stated these products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 201(p) of the FD&C Act, requiring prior FDA approval under section 505(a). Furthermore, the products are considered misbranded under section 502(f)(1) of the FD&C Act because they are for conditions not amenable to self-diagnosis and treatment, thus lacking