Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
Center for Biologics Evaluation and Research
January 16, 2004
PO Box 726
London, England EC1 V 7QQ
To Whom It May Concern:
The Food and Drug Administration (FDA) has reviewed your website
at Internet iddress: http://www.biologicalmiracle.com and has determined that
your product the Antidote, which is purported to be an Anti-Microbial
Peptide derived-from the blood of crocodiles, 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].
The Antidote is considered to be a drug because the therapeutic claims, as shown on your website, establish its intended use as a drug. In describing the Antidote, your website states, among other things, that: It will fight and protect your body from all virus and bacteria activated infections; The miracle healing powers of the Antidote can now be used to fight all known human viruses and bacteria. The common cold is a thing of the past, even serious infectious diseases such as Cancer, AIDS, SARS and many other life threatening diseases can be helped by the power of the Antidote; and Whether you have the common cold, a terminal illness, or you just want to protect your body from viruses and bacteria in the future, this is the only product you should be purchasing. Your website also states, The Antidote can be taken safely with any current medication you may be using.
Your website also contains personal testimonials that constitute
therapeutic claims. These testimonials include, but are not limited to, the
1. [redacted] states that he had a lung infection,
and after about 80 hours, my lungs seemed to have cleared out and working
freely. Also, this product (at least in in my case) is working as an excellent
2. [redacted] states that she had been diagnosed with Parkinsons Disease in 1990, and The Antidote has done its work on parasites, polarity, biological warfare, viruses, bacteria, candida and even Parkinsons disease.
*Actual names have been removed.
3. [redacted] states, I took my Antidote and have rid my self of the things listed below:
Constant sore throat
Nasal drainage on the back of throat
The Antidote is offered for sale to U.S. citizens
and the Order page of the website provides for payment and shipment
to U.S. addresses. Indeed, the website testimonials are from persons residing
in the United States. This product appears to be avaiIable to anyone who orders
the product Tom your website.
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
products 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 resuh
in regulatory action 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 thenoted
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 responseshould be sent to the U.S. Food
and Drug Administration, Center for Biologics EvaIuation and Research, 1401
Rockville Pike, Suite 200 N, Rockville, Maryland 20852-1448, Attention Mr. Steven
Masiello, Director, Office of Compliance and Biologics Quality.
Steven A. Masiello
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research