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HERBAL PRODUCTS SAFETY DATA REQUESTED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

HERBAL PRODUCTS SAFETY DATA REQUESTED BY FDA in a June 18 Federal Register notice to "assist the agency in evaluating the safety of particular herbal products and herbal products as a category." FDA said it is soliciting data on herbal products to fulfill its "immediate goal" of removing "hazardous products from the market" and to ensure the safety of all marketed herbals. Specifically, FDA requested comments on five questions relating to herbal products, including: how to satisfy the requirement "that the tolerance limitation not be set higher than the level necessary to accomplish the additive's intended physical or other technical effect"; whether the agency should "consider another approach to regulating the safety of herbs"; and, if so, what should the standard be "for determining when the use of the herb is safe?" Another question posed by the agency is "what types of data [such as clinical trials or adverse effect reports] are necessary for establishing safe levels of use for herbs?" FDA concluded its list of queries by asking: "What information should be included on the label to assure safe use of herbal products?"; and is it "necessary to establish specifications and good manufacturing practices to assure the safety of herbal products?" FDA said it needs to make some regulatory decisions on herbal products because "some components contained in these products have been associated with reports of adverse health effects or toxicities in animals and humans." For example, the agency pointed out that "recently, at least six documented cases of toxic hepatitis have been associated with the consumption of chaparral." Chaparral adverse incidents are part of an ongoing FDA investigation ("The Tan Sheet" May 31, p. 5). The scientific literature also documents the toxicity of the Symphytum, Heliotropium and Senecio species, as well as other pyrrolizidine alkaloid (PA) containing plants used in dietary supplements, FDA said. Reports have been filed, for instance, on PAs causing liver injury and failure secondary to veno-occlusive disease, the agency noted. Other herbal product-related adverse incidents cited by FDA include: Germander being implicated in "at least seven cases of acute nonviral hepatitis in France"; chronic renal failure being associated with herbal powders containing Stephania tetrandra and Magnolia officinalis; and adverse reactions linked with supplements containing Lobelia inflata. The agency added that it is "aware that many herbal products are marketed for drug uses without having complied with the drug approval requirements." FDA emphasized that it will take regulatory action against these products on "a case-by-case basis . . . when appropriate." In general, FDA said it "intends to explore approaches to regulations that will enable it to ensure the safety of herbal products in an effective and efficient manner." FDA also called for data on the use of dietary supplements that cannot be classified as vitamins/minerals, amino acids, or herbals. The so-called "other" category includes "fish and plant oils," such as evening primrose oil and black currant oil; fatty acids; fibers and vegetable gums; and carnitine, the agency outlined. Products in the " other" category "are readily available in the marketplace, even though generally very little is known about their safety," FDA said, The agency declared that "many of these substances have no recognized nutritive value or technical effects." In addition, "some of these products have been associated with serious toxicity, such as germanium supplements being linked to nephrotoxicity and gamma hydroxy butyrate (used as a weightlifting aid) being associated with respiratory depression, coma and seizures," FDA said. The agency is soliciting comments on "the availability, sources, ranges, and current uses of 'other' ingredients, as well as information/comments on changing patterns of use of these substances over the last 20 to 30 years." FDA is also asking for "suggestions to further define this category of ingredients." In addition, FDA is inviting comments on some of the same questions asked about herbal products, such as how the tolerance limitation for "other" supplements can be set lower than the level necessary to accomplish the additive's intended physical or other technical effect; which approach to ensuring safety should FDA use; and whether establishing GMPs is necessary to assure the safety of such products. Another question posed by the agency is: What information should be included on the label and what types of data would be necessary to assure safe use? FDA said that once it reviews information and data submitted on "other" supplements, it "will develop appropriate steps to assure the safety and proper labeling of dietary supplements." Such steps, FDA continued, "may include rulemaking, enforcement action, or other appropriate activities." The final report of FDA's Task Force on Dietary Supplements recommended that "the agency find an effective means of ensuring safe use of this 'other' category of ingredients," FDA said. Among the possible regulatory options offered by the task force were: to "continue regulating these ingredients as food additives; to require a description of the nutrient value on the label of foods containing these ingredients; and to bring actions against these substances when they are represented as drugs," according to the Federal Register notice.

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