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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.sharco.tv 12/07/09

   

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

Public Health Service
Food and Drug Administration
  Rockville MD 20857

December 07, 2009


WARNING LETTER


FEDERAL EXPRESS


Mike Lyons
Hamit Koy
Kibris Mersin, CY PK10

Dear Mr. Lyons:

The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (FDA) has reviewed your Internet websites http://www.shacro.tv and http://biologicalmiracle.com and has determined that your product "SHACRO," which is purported to be an "Emulsified Dual Protein Anti-Microbial Peptide" derived from the blood of crocodiles and sharks, is being promoted for conditions that cause it to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)] and a biological product, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 USC 262].

"SHACRO" is considered to be a drug because the therapeutic claims, as shown on your websites, establish its intended use as a drug. In describing "SHACRO," your websites state, among other things, that: "The common cold and even serious infectious diseases such as Cancer, HIV, varying Herpes conditions, with Avian (Bird) Flu - SARS, and the current AIRBORNE SWINE FLU now evident globally, together with many other life threatening diseases can be assisted by the Dual Anti Microbial Peptide healing powers of SHACRO"; "It really is the all inclusive product that will kill all viruses and bacteria...."; "This is the perfect way to fight illness ... "; and " ...it assists and enhances enzymes in the body... producing proteins 10ngeL.. it protects the immune system against virus and bacterial infections." Your websites also state, "SHACRO may be taken safely by children and adults even if on current medication."

Your websites also contain personal testimonials that constitute therapeutic claims.
These testimonials include, but are not limited to, the following:


1. (b)(6) states that "My pneumonia is completely gone."

2. (b)(6) states, "I have hiv... but when I started taking the gator juice, my hiv count first starting going down... MY HIV IS NOT DETECTABLE... I no longer have a tumor. .. I NO LONGER HAVE HIV...."

3. (b)(6) states, "A person with severe cancer condition ... we gave this person SHACRO and today he just checked out of hospital with no sign of cancer."

4. (b)(6) states, "Your product has cleared up my Psoriasis .... I took your product SHACRO, and I have cleared up... thank you for helping me find the cure for Psoriasis"

5. (b)(6) states, "I have had a lung infection after 80 hours, my lungs seem to have cleared out and working freely this product is working as an excellent anti-smoking agent"

6. (b)(6) states, "Thank you for SHACRO. It truly does work miracles ...including my Parkinson's disease"

7. (b)(6) states, "I took my SHACRO and have rid my self of the things listed below:

• Candida
• Fever blisters
• Constant sore throat
• Nasal drainage on the back of the throat"

"SHACRO" is offered for sale to U.S. citizens and the "Order" pages of the websites provide for payment and shipment to U.S. addresses. This product appears to be available to anyone who orders the product from your websites.

Please be advised that in order to introduce or deliver for introduction a biologic into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product's intended use. While in the development stage, biologic products may be distributed for clinical use in humans only if the sponsor has on file an accepted investigational new drug application as specified by the regulations (21 U.S.C. 355(i); 21 CFR Part 312). Your product is not the subject of an approved biologics license application (BLA) or an investigational new drug application (IND). Therefore, your shipments of product for which a valid license or IND is not in effect represent violations of the Act and the PHS Act and may result in the Agency seeking such relief as provided by law (21 U.S.C. 331).

This letter is not intended to be an all-inclusive review of your website and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Acts and their implementing regulations. You should take prompt action to correct the violations noted above. Failure to promptly correct these violations may result in regulatory actions such as seizure, and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852-1448, Attention Ms. Mary A. Malarkey, Director, Office of Compliance and Biologics Quality.


Sincerely,
/S/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


Enclosure:
Internet website pages from http://www.shacro.tv and http://biologicalmiracle.com


Cc.
Michael Lyons
Digby Road
London, UK E9 6HX