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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Institute for Healthy Aging 02-Jun-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

555 Winderley PI., Ste. 200
Maitland, FL 32751


CERTIFIED MAIL
RECEIPT REQUESTED

WARNING LETTER

FLA-08-19

June 2, 2008

Dr. Mark A. Rosenburg
The Institute for Healthy Aging
101 NW 1st Avenue
Delray Beach, FL 33444

Dear Dr. Rosenburg:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.alternativecancersolution.com and has determined that the products "Green Tea Extract," "Melatonin," "Myco-Immune Complex," "Selenium,""Shark Liver Oil," "Squalamine" and "Vitamin K2" 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 Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are. intended for. use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Green Tea Extract

• "A new study on bladder cancer cells lines shows that green tea extract has potential as an anti-cancer agent, proving for the first time that it is able to target cancer cells while leaving healthy cells alone."

• "[G]reen tea extract works to counteract the development of cancer . . . "

• "Numerous epidemiological and animal studies have suggested that green tea extract provides strong anti-cancer effects in several human cancers, including bladder cancer."

• "[Green tea extract] has been shown to induce death in cancer cells as well as inhibiting the development of an independent blood supply that cancers develop so they can grow and spread."

• "[G]reen tea extract interrupts a process that is crucial in allowing bladder cancer to become invasive and spread to other areas of the body."

Melatonin

• "[M]elatonin can directly kill many different types of cancer cells "

• "[Melatonin] is a naturally produced cytotoxin, which can induce tumor cell death (apoptosis)."

• "[M]elatonin has been shown to inhibit the tumor's growth rate."

• "[M]elatonin has been shown to alleviate numerous cancer symptoms and to inhibit development of new tumor blood vessels (tumor angiongenesis), which in turn inhibits the cancer from spreading further (metastasis)."

Myco-Immune Complex

• "[E]xtracts of medicinal mushrooms.. .have been shown to have powerful anti-tumor activity . . ."

• "Mushrooms contain different beta glucans that have been found to inhibit the growth of cancer."

• "In Japan, extracts containing various types of Beta glucan have been used to successfully assist in treating cancer, patients for the last 20 years."

Selenium

• "Methylselenocysteine is one of the most biologically active, and cancer inhibitory and preventive . . . "

• "It has become increasingly evident that dietary Se plays a significant role in reducing the incidence of lung, colorectal and prostate cancer in humans."

Shark Liver Oil

• "The biologic effects of shark liver oil include . . . anti-tumor activity."

• "[A]lkylglycerols led to lowered cancer cell reproduction and a reduced ability of the cancer cells to invade healthy cells."

• "[A]lkylglycerols possess both cancer preventative properties, as well as cancer treatment effects."

Squalamine

• "Squalamine may be potentially useful as an anti-angiogenic therapy for some types of cancer."

Vitamin K2

• "K2 killed some leukemia cells by apoptosis . . ."

• "K2 could kill (by apoptosis) a variety of different types of lung cancer cells, including small cell carcinomas, adenocarcinomas, squamous cell carcinomas and large-cell carcinomas."

• "Since [vitamin] K2 is a safe medicine without prominent adverse effects . . .our data strongly suggest the therapeutic possibility of using [vitamin] K2 for the treatment of patients with lung carcinoma."

• "[K]2 inhibits the growth and invasion of hepatocellular carcinoma (liver cancer) cells. . ."

• "[A] role for K2 in preventing liver cancer was proven."

Further, the Alternative Cancer Treatment - Articles pages of your website cite a number of articles about studies of the ingredients in your products. These articles concern the use of the ingredients in your products for treatment or prevention of cancer and other diseases. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.

The following are examples of reference citations used to market your products for disease treatment and prevention on your website:

• "The beneficial effects of mushrooms; A preventative and adjuvant therapeutic strategy against cancer. Jason A. Bush PhD* and Jason E. Watkin# *Cancer Research Center, The Burnham Institute, La Jolla, CA, 92037 USA #Biomedica Laboratories Inc, Duncan, BC, Canada."

• "Takaku T, Kimura Y, Okuda H. Isolation of an antitumor compound from Agaricus blazei Murill and its mechanism of action. J Nutr. (2001) 131: 1409-13."

• "Oshiman K, Fujimiya Y, Ebina T, Suzuki I, Noji M. Orally administered beta-1,6-Dpolyglucose extracted from Agaricus blazei results in tumor regression in tumor-bearing mice. Planta Med. (2002) 68: 610-4."

• "Kidd PM. The use of mushroom glucans and proteoglycans in cancer treatment. Altern Med Rev. (2000) 5: 4-27."

• "Borchers AT, Stern JS, Hackman RM, Keen CL, Gershwin ME. Mushrooms, tumors, and immunity. Proc Soc Exp Biol Med. (1999) 221: 281-93."

• "Sliva D, Labarrere C, Slivova V, Sedlak M, Lloyd FP Jr, Ho NW. Ganoderma lucidum suppresses motility of highly invasive breast and prostate cancer cells. Biochem Biophys Res Commun. (2002) 298: 603-12."

• "Kodama N, Komuta K, Nanba H. Can maitake MD-fraction aid cancer patients? Altem Med Rev. (2002) 7: 236-9."

• "Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. L. C. Clark, G. F. Combs Jr, B. W. Turnbull, E. H. Slate, D. K. Chalker, J. Chow, L. S. Davis, R. A. Glover, G. F. Graham, E. G. Gross, A. Krongrad, J. L. Lesher Jr, H. K. Park, B. B. Sanders Jr, C. L. Smith and J. R. Taylor Arizona Cancer Center, College of Medicine, University of Arizona, Tucson, USA."

• "Cytostatic and cytotoxic effects of alkylglycerols (Ecomer) Krotkiewski M; Przybyszewska M; Janik P Sahlgrenska Academy, Goteborg University, Gothenburg Institute of Clinical [sic] Neuroscience, Goteborg, Sweden."

• "Squalamine and cisplatin block angiogenesis and growth of human ovarian cancer cells with or without HER-2 gene overexpression. Dan Lil, Jon I Williams2 and Richard J Pietras 1 I UCLA School of Medicine, Department of Medicine, Division of Hematology-Oncology and Jonsson Comprehensive Cancer Center, Los Angeles, California, CA 90095, USA. 2Genaera Corporation, Plymouth Meeting, Pennsylvania, PA 19462, USA Correspondence to: RJ Pietras, Department of Medicine, Division of Hematology-Oncology, 10833 Le Conte Ave., 11-934 Factor Bldg., Los Angeles, CA 90095-1678, USA"

• "Vitamin K2 may curb liver cancer in women with viral cirrhosis Reuters Health Last Modified: November 1, 2001 Last Updated: 2004-07-21 10 :42:10 -0400 (Reuters Health) JAMA 2004;292:358-361. "

• "Vitamin K2-induced antitumor effects via cell-cycle arrest and apoptosis in gastric cancer cell lines. Int J Oncol. 2005; 26(1):33-40 Yokoyama T; Miyazawa K; Yoshida T; Ohyashiki K First Department of Internal Medicine, Tokyo Medical University, Nishishinjuku, Shinjuku-ku, Tokyo, Japan"

• "Menatetrenone, a Vitamin K2 Analogue, Inhibits Hepatocellular Carcinoma Cell Growth by Suppressing Cyclin D1 Expression through Inhibition of Nuclear Factor B Activation Iwata Ozakil,2, Hao Zhangl,3, Toshihiko Mizutal, Yasushi Idel, Yuichiro Eguchil, Tsutomu Yasutakel, Toshiyuki Sakamaki4, Richard G. Pestell4 and Kyosuke Yamamoto 1"

Also, the URL address for your website suggests the products are intended for use in curing, mitigating, treating or preventing cancer.

The reference citations and other claims quoted above are supplemented by the metatags used to bring consumers to your website through internet searches. The metatags include "Alternative Cancer Treatments for natural cancer cures," "Holistic treatment for Cancer," "Vitamin C and cancer," "Institute for Healthy Agirig helping natural cancer cures," "alternative cancer treatment," "cancer treatment," "holistic cancer treatment," "alternative cancer therapy," "cancer therapy," "natural cancer cure," "alternative cancer cure," "cancer healing," "natural cancer cure vitamin c" and "alternative cancer clinic"

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are "new drugs" under section 201 (p) of the 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 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. Your products "Green Tea Extract," "Melatonin," "Myco-Immune Complex," "Selenium," "Shark Liver Oil," "Squalamine" and "Vitamin K2" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directioris for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you promoted another product for disease treatment and/or prevention. It is your responsibility to ensure that products marketed by your firm comply with the Act and its, implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those 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 the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issues in this letter, please contact Ms. Shambaugh at 407 475-4730.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District