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.