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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SAFE USE LEVELS ENDORSED BY LONZA in Dec. 6 comments submitted to FDA by the nutritional chemical manufacturer's Washington, D.C. counsel Morgan, Lewis & Bockius attorney Kathleen Sanzo. Writing in response to FDA's dietary supplement advance notice of proposed rulemaking published in the June 18 Federal Register, Lonza said it concurred with the agency's recommendations to initiate "notice-and-comment rulemaking procedures" to establish safe use levels for vitamins, minerals and other substances. The establishment of safe maximum intake levels for vitamins and minerals is recommended in the final report of FDA's Task Force on Dietary Supplements, FDA noted in the June 18 advance notice of proposed rulemaking ("The Tan Sheet" June 21, p. 1). The task force recommended that FDA use "notice and comment rulemaking" to establish safe use levels, or "dietary supplement limits" (DSLs), for vitamins and minerals. Lonza recommended that "use at or below these levels" should be "deemed safe by FDA, whereas additional data and information" should be required "to support any dietary supplement uses above these levels." Lonza also urged FDA to begin the rulemaking process with a call-for- data on the "safe use of dietary supplements . . . including marketing and scientific data to support the safety of specific uses and use levels of supplement ingredients." The company suggested that the agency "set priorities for its review of substances based on use patterns and potential safety issues." The manufacturer also recommended that FDA allow supplement manufacturers in the interim to "continue marketing their products regardless of their compliance with specific proposed DSLS, unless FDA can demonstrate affirmatively that current use levels present significant safety concerns." Lonza maintained that such a policy would be "consistent" with FDA's treatment of OTC drug products under the monograph system. In addition, Lonza asserted that it is "reasonable" and "scientifically appropriate" for FDA to rely on the "type of data generally required to support food substance marketing authorization," such as generally recognized as safe (GRAS) petitions or "food additive" petitions. The company contended that manufacturers "can and should continue to rely, where appropriate, on self-affirmation of GRAS status with respect to safe use of a particular food substance." Such an approach, Lonza suggested, would not require "significant FDA resources" to reach a safety determination. Lonza also addressed the regulatory status of carnitine, which FDA categorized as an "other" dietary supplement as opposed to vitamins and minerals. While the agency is considering options on how to regulate "other" dietary supplements ("The Tan Sheet" June 21, p. 6), Lonza recommended that such substances be regulated "consistent" with FDA's approach to vitamin and mineral supplements. The company also took issue with recent comments submitted to FDA by Vitaline, which suggested that carnitine could be regulated as a "medical food" if the agency decided not to allow marketing the product as a dietary supplement ("The Tan Sheet" Nov. 15, p. 18). Lonza maintained that if the "claims" for carnitine's intended use are "nutritional and non-therapeutic," and its safe consumption "does not require medical supervision, the substance properly should not be regulated as a medical food but, rather, as a dietary supplement." The company asserted that for a substance to be deemed a "medical food," a product "must be labeled for the dietary management of [a] medical disorder, disease or condition . . . and must be labeled for use under medical supervision." Lonza said it "knows of no instance in which carnitine is labeled for use under medical supervision." Lonza also disagreed with Sigma Tau that dietary supplements with L-carnitine should contain only 100% L-carnitine USP. Lonza maintained that there is no evidence to support this position and that to exclude other forms of L-carnitine (tartrate, fumarate and magnesium citrate) from the marketplace would "serve only narrow competitor interests for no public policy purpose consistent with the agency's interests or concerns." Maintaining the the establishment of dietary supplement GMPs are "unnecessary," Lonza argued that such an approach would require "additional significant FDA resources" and would be "unnecessarily costly to industry." Lonza asserted that the cost to FDA of promulgating new GMPs is "significantly outweighed by the marginal, if any, gain in safety that may result in this exercise," pointing out the significant expenditure of FDA resources that was required to establish the revised device GMPs. Instead, Lonza suggested that the current GMPs for food products are sufficient for the manufacture of dietary supplements. If FDA is to regulate dietary supplements as foods, Lonza contended, they should be "subject to food GMPs in order to maintain consistency and undistorted competition in the food industry."

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