Inspections, Compliance, Enforcement, and Criminal Investigations
Merazon Health Products, Inc. 01-Mar-06
Department of Health and Human Services
Public Health Service
March 1, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-20
Charles F. Macurdy, President
Merazon Health Products, Inc.
11201 Greenwood Avenue North
Seattle, WA 98133-8612
Dear Mr. Macurdy:
In conjunction with an inspection of your firm on November 9, 15, and 18, 2005, the Food and Drug Administration (FDA) reviewed your firm's websites at http://www.merazon.com; http://www.meraqenesis.com, and http://www.provelex.com/. Our review of your websites found violations of the Federal Food, Drug, and Cosmetic Act (the Act) as described below. You can find the Act and FDA's regulations through links on FDA's Internet home page at http://www.fda.gov. Under section 201(g)(1)(B) of the Act (21 U.S.C. 321 (g)(1)(13)), articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Based on claims that appear on your website for your products Immune Guard and Provalex Prostate, we have determined that these products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B). The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the disease claims observed on your websites for these products include the following:
http://www.meragenesis.com: "Traditional flu shots, even if you can get them, do not guarantee you won't get the flu. With Immune Guard, you are helping your body's ability to fight many different kinds of influenza viruses and the common cold."
This second sentence quoted above was the same internet claim that was brought to your attention in a Warning Letter sent to you by our Center for Food Safety and Applied Nutrition (CFSAN), dated February 4, 2005. At the conclusion of the November 2005 inspection, our investigator again brought to your attention that these claims were still present on your internet website at http://www.meraqenesis.com.
http://www.merazon.com; http://www.meragenesis.com; "Provelex™ Prostate Support formula contains Quercetin, a potent antioxidant that has been shown to reduce the size of the prostrate. This expanded . . . formula also has 33% more Beta Sitosterol, an inhibitor in the production of the chemical Dihydrotestosterone. Accumulation of this chemical leads to prostate gland enlargement."
http://www.provelex.com/: [under the heading "NEW FORMULATION! Provelex Prostate Support]
"Swedish Flower Pollen has been the subject of several clinical studies in treating chronic, nonbacterial prastatis and BPH. These studies have produced strong results supporting its reputation as a prostate treatment, as well as indicating the effectiveness reducing
arteriosclerosis . . ."
"Quercetin, another anti-oxidant, also helps to reduce the size of the prostate . . . Quercetin may inhibit the growth of cells that damage the prostate, while others have suggested that it may also help reduce LDL cholesterol and even act as an antihistamine."
Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505 of the Act (21 U.S.C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These drugs are also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that their labeling does not bear adequate directions for use.
This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for the seizure of illegal products, and for injunctions against the manufacturers and/or distributors of illegal products [21 U.S.C. 332 and 334].
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations and an explanation of each step taken to assure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Elrand, Compliance Officer, 2220123rd Drive SE, Bothell, Washington 98021-4421.
Charles M . Breen