What
the FDA (Food and Drug Administration) said about
the ingredients in the "H" and other well-known
creams
Perhaps
you may want to know more about the FDA, the
well-known federal agency, so you can better
understand why anything coming out of this office
is so important, and CREDIBLE.
The FDA ensures that the food we eat is safe and
wholesome, that the cosmetics we use won't harm us
and that the medicines, medical devices, and
radiation-emitting consumer products, such as
microwave ovens, are safe and effective.
Authorized by Congress to enforce the Federal
Food, Drug and Cosmetic Act and several other
public health laws, the agency monitors the
manufacture, import, transport, storage and sale
of $1 trillion worth of goods annually, at a cost
to taxpayers of about $3.00 a person.
The FDA has over 9,000 employees, located in 157
U.S. cities. Among its staff, FDA has 2,100
scientists 900 chemists and 300 microbiologists,
who work in 40 laboratories across the country.
Also included are 1,100 investigators and
inspectors who visit 15,000 facilities a year as
part of their oversight of the 95,000 businesses
that the FDA regulates.
Now, this is the report about the ingredients in
some creams sold for the treatment of hemorrhoids
FDA TALK PAPER FOOD AND DRUG ADMINISTRATION
US Department of Health and human Resources
Public Health Service, 850 Third Avenue, Brooklyn
NY 11232
T93-42
September 3, 1993
New York District Public Affairs Office
Herman B. Jniger, Public Affairs Specialist
Barbara A. Miller, Public Affairs Technician
(718) 965-5043
FDA Actions on OTC grand Defongal, Hemorrhoidal
and Laxative Products
FDA has issued two final rules and one proposed
rule affecting many over-the counter, anti-fungal,
hemorrhoidal and laxative products. The following
provides background about the documents published
in The Federal Register on September 2nd, 1993.
Hemorrhoidal Products.- FDA's action will prohibit
use of live yeast derivative (LYCD) in over-the
counter hemorrhoidal products until it is proved
to be effective.
LYCD is listed as an active ingredient in some
hemorrhoidal products claiming to treat symptoms
of pain itching, burning or irritation, and to
shrink the swelling of hemorrhoidal tissue caused
by inflammation.
Since LYCD is classified by FDA as a wound-healing
agent the agency requested manufacturers to show
that the ingredient is effective in treating
hemorrhoidal systems. After reviewing the two
submitted studies, FDA concluded that neither
adequately supported claims of effectiveness.
All manufacturers are required to move anti-hemorrhoidal
claims specifically attributed to LYCD, and
companies marketing LYCD will need to reformulate
their products using proven ingredients.
The published rule will go into effect in one
year. Products affected include Preparation H,
Formulation R and Prompt Relief.
Comments on the proposed rule may be sent within
sixty days to:
Dockets Management Branch (HFA-305), FDA Room
1-23, 124 Parklawn Drive, Rockville, MD 20857,
After reexamining the available data and
considering new information, the agency concluded
that docusate salts are safe and effective as OTC
laxatives. As a result, docusate calcium and
docusate sodium are being proposed for oral use
and docusate potassium for rectal use.
There are over 50 products on the market that
contain docusate salts. Examples include COLACE,
CORRECTOL, DIALOSE, DOXIDAN, DOXINATE, AND FEEN-A-MINT.
Our comments: Just because the manufacturer of a
product spends millions of dollars advertising
that it works, it does not mean it is true. We
should always be on the look out for alternatives,
new products and use our common sense. It is
logical that some chemical ingredients irritate,
due to allergic reactions. Whenever possible, we
should use Natural products. Of course, we should
be careful and make sure that the product we try
has been registered with the FDA.
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