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FDA Warns Bell Lifestyle for Heart Product Claims

August 23, 2011

4 Min Read
FDA Warns Bell Lifestyle for Heart Product Claims

DETROITMarketing claims for two heart health products earned H & L Jerch Inc., d.b.a. Bell Lifestyle, South Haven, MI, a warning letter from FDA. The agency said Bell Lifestyles Heart Garlic Support Combo and Nattokinase Heart Attack & Stroke Prevention products are marketed in a way that makes them intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans, which violates section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. § 321(g)(1)(B).

Nick A. Jerch, president, received a letter from FDA noted that the agency reviewed Bell Lifestyles website and product catalog and found such examples therapeutic claims regarding Nattokinase Heart Attack & Stroke Prevention:

  • Helps by increasing blood flow and lowering blood pressure[.]"

  • Decreases risk of heart attacks & strokes past middle age."

  • Effectively helps to avoid blood clots that can frequently lead to heart attacks and stroke[s]."

Literature for Nattokinase Heart Attack & Stroke Prevention had the following product claims, according to FDA:

  • Decrease risk of heart attack & strokes past middle age. . . . Effectively helps to avoid blood clots that can frequently lead to heart attacks and stokes."

  • Experts say this is the best help to prevent heart attacks and strokes for everyday, with no side effects.

  • Go to the internet and get more details from health care professionals stating that Natokin[a]se may actually be superior to conventional clot-dissolving drugs such as recombinant tissue plasminogen activators (rt-PA) urokinanse, and streptokinase, which are effective therapeutically when taken intravenously within 12 hours of a stroke or heart attack. Natokinase, however, may help prevent the conditions leading to blood clots."

Claims observed on the product label of Nattokinase Heart Attack & Stroke Prevention included:

  • Nattokinase Helps to prevent Heart Attacks & Strokes"

  • Decrease the risk of heart attacks & strokes past middle age."

  • Effectively helps to avoid blood clots that can frequently lead to heart attacks and strokes, the #1 killer in North America."

Examples of some of the therapeutic claims observed regarding Heart Garlic Support Combo online included:

  • Helps to prevent heart attacks, strokes, arteriosclerosis, high blood pressure, blanches low blood pressure."

  • Wild garlic regulates cholesterol, prevents blood clogging and improves microcirculation."

Product literate for Nattokinase Heart Attack & Stroke Prevention included:

  • Wild garlic . . . prevents blood clotting and improves microcirculation. It helps to prevent heart attacks, stokes and arteriosclerosis. Wild garlic may reduce high blood pressure and low blood pressure."

Claims observed on the product label of Heart Garlic Support Combo include:

  • It helps . . . to prevent blood clogging, heart attacks, strokes, arteriosclerosis, high blood pressure, blanches low blood pressure."

Claims in the form of personal testimonials in the product catalog disease, specifically:

  • Diabetes health problems resolved! Bells Heart Support Garlic Combo solved many health problems. As a diabetic for 11 years my immune system was weak. I got cold after cold and was congested all the time. Since taking 2 capsules in the morning and 1 at night I have not been sick with a cold or sore throat."

Because both products are not GRAS (generally recognized as safe) and effective for the above-referenced uses, the products are new drugs" under section 201(p) of the FD&C Act,21 U.S.C. § 321(p), according to FDAs warning letter.

Furthermore, FDA said products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended uses. Thus, the products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1), in that the labeling fails to bear adequate directions for use.

 FDA gave the company 15 working days of receipt of the letter to outline the specific steps it has taken to correct the violations. FDA said the response should include each step that has been taken or will be taken in the future to correct the violations and prevent their recurrence.

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