fda.govg4730d.htmOpen ↗ May 19,
2004
VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 04-30
Leonard G. Horowitz, D.M.D., M.A., M.P.H.
Owner/President/Managing Member Healthy World Distributing
206 North 4th Avenue, Suite 147 Sandpoint, Idaho 83864
WARNING LETTER
Dear Dr. Horowitz:
This letter refers to your firm's marketing and
distribution of the products "Urbani SARS Formula Nasal
Spray", " Urbani SARS Formula (Standard)", "Extra Strength
Urbani SARS Formula", and "Urbani SARS Formula Homeopathic
(6X)" for the prevention, treatment, or cure of Severe
Acute Respiratory Syndrome.
Statements made on your Internet websites,
healthyworlddistributing.com and cureforsarsnet, demonstrate
that these products are being marketed with drug claims.
Examples of these claims include: "Scientifically formulated
as a natural defense and effective treatment for coronavirus
infections." Under section 201 (g) of the Federal Food,
Drug, and Cosmetic Act (Act), products marketed with such
claims are drugs.
The products "Urbani SARS Formula Nasal Spray", " Urbani
SARS Formula (Standard)", and "Extra Strength Urbani SARS
Formula" are "new drugs" under section 201 (p) of the Act
because they are not generally recognized by qualified
experts as safe and effective for their intended uses. Since
these products are new drugs, section 505(a) of the Act
prohibits their marketing in the United States without
approved new-drug applications.
Because the "Urbani SARS Formula Homeopathic (6X)" is
intended to prevent, treat, or cure a serious disease that
requires diagnosis and treatment by a physician, it is a
drug that is not safe for use except under the supervision
of a practitioner licensed by law to administer it.
Accordingly, this product is misbranded within the meaning
of Section 503(b)(1) of the Act. The product is further
misbranded within the meaning of Section
503(b)(4) of the Act in that its label fails to bear the
statement "Rx only" .
In addition, these products are misbranded under section
502(f)(1) of the Act because their labeling fails to bear
adequate directions for use for the conditions that they are
intended to treat.
This letter is not intended to be an all-inclusive review of
your Internet web sites and the products marketed by your
firm. It is your responsibility to ensure that all of your
firm's products comply with the Act and its implementing
regulations.
We request that you take prompt action to correct the noted
violations. Failure to promptly correct these violations
may result in enforcement action being initiated by the
Food and Drug Administration without further notice. The
Act provides for the seizure of illegal products and for
injunctions against the manufacturer and/or distributor of
those products.
Please notify this office in writing within fifteen working
days of receipt of this letter regarding the steps that you
have taken to correct the noted violations. You should also
include an explanation of each step being taken to ensure
that similar violations do not recur. 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 implemented.
Please send your reply to the Food and Drug Administration,
Attention: Lisa
M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell,
Washington 98021-4421.
By copy of this letter, Mr. Mark Gustafson, Administrative
Contact for the domain name www.healthyworlddistributing,
will be notified of this action.
Sincerely, /s/
Charles M. Breen