| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human Services
WARNING LETTER
2011-DET-14
VIA UPS
August 10, 2011
Mr. Nick A. Jerch, President
H & L Jerch, Inc., (d.b.a.) Bell Lifestyle
07090 68th Street
South Haven, MI 49090
Dear Mr. Jerch:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your web site at http://www.belllifestyle.com in July 2011 and your product catalog in June 2011. In addition FDA reviewed the label of your “Nattokinase Heart Attack & Stroke Prevention” product. The FDA has determined that your “Heart Garlic Support Combo” and “Nattokinase Heart Attack & Stroke Prevention” products are promoted for conditions that cause the products to be drugs under 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). The therapeutic claims on your web site, product catalog, and product label establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. The marketing of your products with these claims violates the FD&C Act.
Examples of some of the therapeutic claims observed regarding “Nattokinase Heart Attack & Stroke Prevention”
Claims observed on your web site include:
- “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].”
Claims observed in your product catalog include:
- “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” include:
- “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”.
Claims observed on your web site include:
- “Helps to prevent heart attacks, strokes, arteriosclerosis, high blood pressure, blanches low blood pressure.”
- “Wild garlic regulates cholesterol, prevents blood clogging and improves microcirculation.”
Claims observed in your product catalog include:
- “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 your product catalog disease, specifically:
- “Diabetes health problems resolved! Bell’s 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.”
Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act,21 U.S.C. § 321(p). New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the FD&C Act, 21 U.S.C. § 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your “Heart Garlic Support Combo” and “Nattokinase Heart Attack & Stroke Prevention” 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, your 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. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
The above is not intended to be an all-inclusive list of violations. You are responsible for ensuring that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations. Your response should include each step that has been taken or will be taken in the future to correct the violations and prevent their recurrence. If you cannot complete all corrections before your response, please state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.
Sincerely,
/S/
Keith J. Jasukaitis
Acting District Director
Detroit District Office
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