HHS NEWS

P97-30                           FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE            Susan Cruzan:     (301)827-6242

August 29, 1997                  

                                 Consumer Hotline: (800)532-4440 





       FDA PROPOSES BAN ON OTC SALE OF LAXATIVE INGREDIENT



     FDA is proposing to ban the over-the-counter (OTC) sale of

phenolphthalein, an ingredient widely used in laxatives, because

it may pose long-term safety concerns.  The proposal would

require that products containing this ingredient either be

reformulated or withdrawn from the market.

     The proposal to reclassify phenolphthalein as unsafe is

based on a review of animal carcinogenicity studies carried out

under the National Toxicology Program (NTP) and presented at a

recent FDA meeting.  Although epidemiological human data has not

revealed any reports of cancer in humans related to the use of

phenolphthalein, the animal studies indicate a potential cancer

risk to people who use this ingredient at higher than recommended

doses or for extended periods of time.  

     Specifically, the two year studies showed that rats and mice

which were fed high doses of phenolphthalein -- approximately 50

to 100 times the recommended dose for humans -- developed a 

variety of tumors.  Other studies have shown that when mice were

fed high doses of the same chemical for six months at 30 times

the recommended human dose, they also developed tumors, as well

as genetic damage.

     After reviewing this and other data, the FDA committee 

concluded that phenolphthalein, which has been used in several

products for many years, potentially could cause cancer in

humans.  Because consumers have access to more than two dozen

laxative products without this ingredient, FDA believes that

phenolphthalein's benefits do not outweigh its risks. In today's

Federal Register, the agency is proposing to reclassify

phenolphthalein as a Category II ingredient, or an ingredient not

generally recognized as "safe and effective". 

     Some manufacturers have recently reformulated their products

with other laxative ingredients.  Consumers are advised to read

OTC laxative drug product labels carefully to be informed of

changes in the active ingredients.  The Nonprescription Drug

Manufacturers Association has adopted a voluntary program called

"Flag the Label" to aid consumers in recognizing when major

changes have occurred in OTC drug products.  This flag on the

label alerts consumers to read the new label information.  

     Today starts a 30-day comment period on the new proposal.

A final regulation will be issued following a review of the

comments, which can be sent to Dockets Management Branch,

HFA-305, RM 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

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