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Note: The entire meeting was open to the public. Copies of written information provided to the Committee for consideration are available from the Committee Staff. This includes written materials received from public participants transcript of this meeting, is available from the FDA Dockets Management Branch (HFA-305), 12420 Parklawn Drive, Rockville, MD 20857.
Special Working Group on Stimulant Laxative Substances in Foods
Dr. Terry Troxell, Office of Plant and Dairy Foods and Beverages, introduced FDA's tentative views on foods containing stimulant laxative substances that may cause adverse gastrointestinal effects. These food products--often called dieter's teas--are not labeled specifically for promoting laxation but they are promoted for cleansing the system. He noted that the Special Working Group charge, and therefore the Committee's, was not to determine whether these teas were drugs, but only to review safety of products that FDA may determine are foods.
Ms. Betty Campbell, Office of Food Labeling, educated committee members on FDA's four potential strategies to protect public health ("risk management" approaches): consumer education, cautionary labeling, regulatory action to remove individual products from the market, and prohibition. Ms. Campbell emphasized that any action by FDA would be governed by statute. Based on the Special Working Group's determinations, the Committee was asked to consider whether a public education effort was warranted either instead of or in addition to requiring special label statements.
Dr. Wayne Askew, Chair of the Special Working Group provided a summation of the issues brought before the Group, its findings, and its recommendations First, the product, while not demonstrated to be causal, has been associated with nine consumer deaths. The members or the Special Working Group were given presentations on chemical constituents of these laxative products, the toxicology of laxatives, labeling aspects, regulatory status of the issue, and regulatory options.
Based on personal knowledge and information received, the Special Working Group was able to come to agreement on the 5 questions posed by FDA (see minutes of the Special Working Group). In addition, the Group went beyond its mission by developing a label statement. Beginning with the word either Notice or Warning it read as follows:
"Contains herbs (insert whatever the herbs are) that can act as stimulant laxatives. Prolonged steeping time can increase the risk of adverse laxative effects including nausea, vomiting, abdominal cramps, and diarrhea. Chronic use of laxatives can impair colon function. Use of laxatives may be hazardous in the presence of abdominal pain, nausea, vomiting, or rectal bleeding. Laxative-induced diarrhea does not significantly reduce absorption of food calories. Acute or chronic diarrhea may result in serious injury or death."
The Special Working Group members recognized that the label statement was extensive but felt it fully expressed their concerns. It would now be left to CFSAN to work with the General Counsel and develop a practical warning statement.
The Acting Chair received a general consensus of acceptance from the full Committee. Having heard no objections, the Acting Chair declared that the Food Advisory Committee would endorse the recommendations of the Special Working Group on Stimulant Laxative Substances in Foods.
This meeting was held in June 1995.
For more recent information on Dietary Supplements
See http://www.cfsan.fda.gov/~dms/supplmnt.html
Hypertext updated by ear/dms/kwg 2000-NOV-27