Anyone Taking HGH?

Human Growth Hormone (HGH) is the active ingredient in a
number of human prescription drugs approved for marketing in
the U.S. under new drug applications (NDAs). FDA-approved
HGH can be legally prescribed for a limited number of
conditions including:

* hormonal deficiency that causes short stature in
children;

* long-term treatment of growth failure due to lack of
exogenous GH secretion;

* long-term treatment of short stature associated with
Turner syndrome;

* adult short bowel syndrome;

* adult deficiency due to rare pituitary tumors or their
treatment; and

* muscle-wasting disease associated with HIV/AIDS.

HGH has important benefits, but also serious, known risks.
Among the possible long-term side effects of HGH is an
increased risk of cancer, and other dangerous side effects
have been reported, including nerve pain and elevated
cholesterol and glucose levels. For this reason, HGH is
carefully regulated in the U.S.

The cost of approved HGH products is high, averaging several
hundred dollars per dose. Because of this high cost, HGH
drugs have been counterfeited and unapproved HGH products
are offered for sale to U.S. consumers. For example, we
have encountered HGH products imported as a lyophilized
powder and declared as an active pharmaceutical ingredient
(API) for pharmacy compounding. Some pharmacies promote
compounded HGH for anti-aging purposes. It is sold as a
"fountain of youth" in longevity clinics and to build body
mass, weight loss, increase libido, and gain stamina. None
of these indications are in the labeling of the FDA approved
products.

The agency is aware of unapproved HGH finished dosage form
products being imported into the U.S. and recently noted a
large increase of HGH being offered for import for pharmacy
compounding. If the drug is bought from foreign sources or
over the Internet, safeguards built into the U.S. drug
distribution system may be bypassed, placing consumers who
use HGH at higher risk.

Section 303(e) (1) of the FDCA, 21 U.S.C. 333(e) (1),
prohibits knowingly distributing, or possessing with the
intent to distribute, HGH for any use in humans other than
the treatment of a disease or other recognized medical
condition, where such use has been authorized by the
Secretary of Health and Human Services (HHS) under section
505 of the FDCA (21 U.S.C. 355) and pursuant to the order
of a physician. The Secretary of HHS has not authorized,
for example, any HGH use for anti-aging, bodybuilding, or
athletic enhancement. Thus, distributing, or possessing
with the intent to distribute, HGH for these uses or any
other unapproved use violates section 303(e) (1) of the
FDCA. A violation of section 303(e)(1) carries up to 5
years imprisonment and fines and, if the offense involves an
individual under the age of 18 years of age, up to 10 years
imprisonment and fines.

HGH products are new drugs and cannot be legally marketed in
the U.S. without an approved application. The few HGH
products that have been approved for sale by FDA are sold
either in liquid form or as lyophilized powders that are
labeled for reconstitution by the health care professionals
who dispense them. Accordingly, FDA considers both imported
HGH lyophilized powder products and liquid HGH products to
be finished dosage form drugs, not APIs. Unless these
products are the subject of approved new drug applications,
they violate section 505 of the FDCA, 21 U.S.C. 355, and
may not be legally imported into the U.S.

Some HGH marketers may claim that their HGH drug products
are intended for use in pharmaceutical compounding. These
drugs should be evaluated on a case-by-case basis
considering the factors in FDA Compliance Policy Guide,
section 460.200, and the specific prohibitions set forth in
section 303(e) of the FDCA, 21 U.S.C. 333(e). The use of
HGH in pharmacy compounding is addressed in more detail,
below.

Some HGH marketers may claim that their HGH products are
dietary supplements. FDA first approved HGH as a new drug
in 1940, and HGH was not marketed as a dietary supplement,
or as a food, before then. Accordingly, HGH is excluded
from the definition of a dietary supplement under section
201(ff) (1) of the FDCA (21 U.S.C. 321(ff) (3) (A))
because growth hormone was an article approved as a new drug
under section 505 of the FDCA (21 U.S.C. 355) before its
introduction as a dietary supplement.