Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  555 Winderley PI., Ste. 200
Maitland, FL 32751

CERTIFIED MAIL
RECEIPT REQUESTED

June 2, 2008

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

WARNING LETTER
FLA-08-19

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

Melatonin

Myco-Immune Complex

Selenium

Shark Liver Oil

Squalamine

Vitamin K2

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:

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

This page was posted on July 19, 2010.

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