This
letter is in reference to your distribution and promotion
of eggs containing antibodies produced by immunization of
chickens with investigational vaccines
From
available documents and an interview between you and Food
and Drug Administration (FDA) investigator Hugh McClure
held on March 23, 2001, FDA determined that you provided
to human subjects eggs containing antibodies produced by
immunization of chickens with investigational vaccines in
violation of the Public Health Service Act (PHS Act) and
the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The
eggs containing antibodies produced by immunization of chickens
with investigational vaccines are biological products as
defined in Section 351(i) of the PHS Act (as amended November
21, 1997), in that they are biological products applicable
to the prevention, treatment, or cure of diseases or injuries
to human beings, and are subject to Section 351(a) of the
PHS Act. Eggs containing antibodies produced by immunization
of chickens with investigational vaccines also are drugs
within the meaning of Section 201(g) of the FD&C Act in
that they are intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man.
Section
351 (a) of the PHS Act is being violated in that unlicensed
biological products (eggs containing antibodies produced
by immunization of chickens with investigational vaccines)
are being introduced or delivered for introduction into
interstate commerce with no approved biologics license application
(BLA) in effect, nor any investigational new drug application
(lND) in effect pursuant to Section 505(i) of the FD&C Act.
The
eggs containing antibodies produced by immunization of chickens
with investigational vaccines are misbranded under Section
502(f)(l) of the FD&C Act because the labeling fails to
bear adequate directions for use. Adequate directions cannot
be written for unapproved drugs.
Your
firm’s website at http://ovimmune.com is promoting your
firm’s egg products and contains the following examples
of therapeutic claims about your firm’s eggs containing
antibodies produced by immunization of chickens with investigational
vaccines:
“Now
specially produced eggs can replace the immunity lost
during these diseases [AIDS, transplant, burn, cancer]
and ameliorate the effects of routine infections.”
..using
egg antibodies to potentially treat all known diseases
“By
hyper-immunizing hens against opportunistic organisms,
lgY can be used to replace failing secreto~ lgA and protect
the mucosa from adhesion of enteric pathogens.. ..”
“We
can produce true ‘magic bullets’ that can be attached
to a lethal agent to target and destroy unwanted biologic
entities such as cancer.”
Furthermore,
the following statement is incorrect for the reasons cited
in this letter and should be removed: “... (Ovlmmune) has
been given GRAS (generally regarded as safe) status from
. .. FDA for the use of egg antibody in human patients..
.“ Readers may misinterpret this statement since it implies
that the FDA reviewed and has permitted the research of
your firm’s investigational eggs for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in
man.
This
letter is not intended to be an all-inclusive list of deficiencies
observed at your facility. It is your responsibility to
ensure adherence to each requirement of the FD&C Act, PHS
Act, and relevant regulations. You should take prompt action
to correct these deviations. Failure to promptly correct
these deviations may result in regulatory action being initiated
by the FDA without further notice. These actions include,
but are not limited to, seizure and/or injunction.
On
March 6, 2004, a caller on my radio show asked about a product
I wasn't familiar with. When I heard it was sold via multi-level
marketing, the red flag was raised. He then went on to explain
that the promotion for this product, a Super Immune Egg, promised
it had the capability of eliminating diabetes and curing cancer.
At this point my brain was filled with red flags waving all
over the place. I promised I'd look into the product and post
my findings at my site.
e-mail
Phil Kaplan