Warning label on stimulant laxative-containing supplements to be required by California.

GNC SELLING STIMULANT LAXATIVE PRODUCTS WITH LABEL WARNINGS; the labels are being used nationwide on GNC-marketed products in response to a recently-issued emergency rule in California, General Nutrition said. The California Department of Health Services (CDHS) is requiring that herb teas and dietary supplements containing aloe, buckthorn, cascara, frangula, rhubarb root or senna -- all of which contain the stimulant laxative chemicals anthraquinones -- bear a label warning statement specifying how and when to use the product.

Pittsburgh, Penn.-based General Nutrition sells Fresno, Calif.-based Laci Le Beau's Super Dieter tea and Alvite Senna Leaf Tea, manufactured by Ronkonukoma, N.Y.-based Twinlab. Both products contain warnings that will be adjusted to the specified California warning, GNC said.

Published in the California Regulatory Notice Register on Nov. 1, the notice of emergency rulemaking goes into effect Jan. 1. The rule exempts products containing a form of aloe -- "leaf gel" -- that does not contain anthraquinones.

The warning statement should read: "NOTICE: This product contains (name of substance(s) and common name if different). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools or abdominal pain. Consult your physician if you have frequent diarrhea. If you are pregnant, nursing, taking medication, or have a medical condition, consult your physician before using this product."

Two other firms with national distribution -- Deer Park, N.Y.-based Body Breakthrough and Phoenix, Ariz.-based Hobe Laboratories -- have informed CDHS that they will relabel their products as well. Body Breakthrough sells Trim-Max Tea with senna. The estimated one-time cost of relabeling is $850 per product.

"Foods and dietary supplements containing substances that can have stimulant laxative effects are causing illnesses, permanent injury, and possibly death in Californians," the notice of emergency rulemaking says. "Consumer protection requires emergency action," it declares.

"The Department's Food and Drug Branch (FDB) has learned of 67 illnesses in first time and regular consumers of `dieter's' teas and up to 10 deaths in regular consumers," the notice continues. "While it has not been proven that these foods caused the illnesses and deaths, use and abuse of stimulant laxatives can cause illnesses and deaths similar to those experienced by individuals consuming these foods." Although most of the adverse events were associated with teas containing senna, all of the substances have the potential to cause stimulant laxative effects and pose the same potential health risks, the notice states.

"Abdominal pain and diarrhea can occur in first-time consumers, but the risk of serious illness (e.g., electrolyte disturbances, particularly hypokalemia, leading to muscle weakness, permanent kidney damage and life-threatening cardiac arrhythmias) appears to arise only after frequent episodes of diarrhea," the notice states. "At least two of the 10 deaths resulted from cardiac arrhythmias during episodes of hypokalemia."

The notice states that while consumers may expect these products to cause laxative effects, they may not necessarily understand that these products can cause other health problems because they are: sold in health food, grocery and drug stores; "bear little or no information about health risks"; and "often claim to be caffeine-free and made with all natural ingredients (claims consumers associate with safety)." The document adds that some consumers use "dieter's teas" and "colon cleanser" as laxatives over OTC drugs, "believing that these products are safer since they do not bear health risk information." In a survey of senna-containing teas, CDHS found the average potency of the "dieter's" teas to be higher than the OTC senna-containing products.

Without "informative" labeling, "consumers continue to consume these products when ill," placing themselves at risk of injury, the notice declares. "Many people do not understand that severe diarrhea lasting one or two weeks, or several episodes of diarrhea a day for months to years can jeopardize their health," it adds.

Written comments on the notice must be submitted to the California Department of Health Services by Dec. 16, the notice says. However, CDHS later noted that it might extend the comment period until Jan. 22. CDHS will review comments and decide whether it wants to continue, change or discontinue the regs. The CDHS recommendation then will be considered by the Office of Administrative Law, which ultimately will decide whether to make the regs permanent.

California would be the first state to adopt such a regulation. FDA's Food Advisory Committee recommended in July 1995 that herbal diet teas bear the warning that the products contain herbs that can act as stimulant laxatives ("The Tan Sheet" July 31, 1995, In Brief). Currently, federal law limits the use of the stimulant laxative-containing ingredients "to levels that do not present a significant or unreasonable risk of illness" but does not specify upper limits.