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Date: Friday, August 29, 1997
FOR IMMEDIATE RELEASE
Contact:  FOOD AND DRUG ADMINISTRATION  
	  Susan Cruzan: (301) 827-6242
	  Broadcast Media: (301) 827-3434
	  Consumer Hotline: (800) 532-4440 

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 The proposal would require that products containing this ingredient either be reformulated or withdrawn from the market.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.