VITALINE WILLING TO SUPPORT L-CARNITINE STATUS AS "MEDICAL FOOD"

VITALINE WILLING TO SUPPORT L-CARNITINE STATUS AS "MEDICAL FOOD," the company told FDA in Nov. 5 comments on the agency's June 18 advance notice of proposed rulemaking on the regulation of dietary supplements. "We believe it is clear that L-carnitine is a proper dietary supplement product," Ashland, Ore.-based Vitaline stated. However, "in the alternative," the company said it "would be willing to have FDA classify use of L-carnitine to supplement the diets of persons who are on dialysis or otherwise suffering from end-stage renal disease as a medical food usage." Vitaline said its L-carnitine product is "intended solely as a nutritional supplement" for individuals who are "unable to obtain an adequate dietary intake of carnitine." However, "for practical purposes," Vitaline said its L-carnitine "already satisfies the description of a medical food because, in general, the majority of those who consume the product are under strict medical supervision." Even if L-carnitine were classified as a medical food when used by patients on dialysis, Vitaline suggested that the amino acid should "still properly be available as a dietary supplement when intended for use by vegetarians and others who desire it simply to supplement their dietary intake." L-carnitine "should not be regulated as a drug when no drug claims are made," the company contended. "However, to ensure that the product is manufactured safely and properly," the company recommended "the establishment of rigorous" good manufacturing practices for dietary supplements. Vitaline markets and distributes OTCs, dietary supplements and medical foods contract manufactured by Formulation Technology which, Vitaline points out, is a licensed drug manufacturer in operation since 1982. Vitaline asserted that its manufacturing, testing and quality control for its L-carnitine products "voluntarily meet or exceed United States Pharmacopeia standard for drugs." In addition, Vitaline took issue with conclusions in the report from FDA's Task Force on Dietary Supplements (also known as the Dykstra Report) that most uses of L-carnitine "should be described as drug uses [because] all conditions in which it is useful as a single substance require medical supervision." The Dykstra Report recognized that L-carnitine can be useful for: persons with genetic carnitine deficiency; newborn infants; persons exposed to certain carboxylic acid drugs or xenobiotics; patients receiving long-term parenteral nutrition; patients on renal dialysis; use in treatment of dementia associated with Alzheimer's disease; and use in minimizing cardiac muscle damage in certain heart disease patients. The Dykstra Report suggested that L-carnitine could qualify as an infant formula ingredient for newborn babies and as a medical food for patients on renal dialysis. According to the Dykstra Report, all other conditions listed should be qualified as drug uses. However, "when sold solely as a dietary supplement or as a medical food," L-carnitine "is not a drug," Vitaline maintained. Vitaline said it does not make drug claims for its L-carnitine products and it does not promote the amino acid for the treatment or cure of chronic renal failure or any other disease. Vitaline also disagreed with the Dykstra Report's conclusion that L-carnitine is "required only by special target populations and not by the ordinary consumer." FDA, the company argued, does not "deny that B vitamins or vitamin C may be sold as dietary supplements even though the majority of the U.S. population does not "require" such supplementation." Vitaline also took exception to a May 25 letter to FDA from Sigma-Tau, which markets prescription Carnitor for the treatment of carnitine deficiency. Vitaline characterized as "unfounded" Sigma-Tau's allegations that the L-carnitine products sold by dietary supplement firms suffer from unacceptable levels of disintegration of tablets due to poor quality control. In response, Vitaline cited in its comments to FDA a letter to the editor of Clinical Research & Regulatory Affairs, the journal that published a study on the bioavailability of L-carnitine supplements that was sponsored by the National Organization of Rare Disorders and conducted at Duke University. Sigma-Tau's Camitor was approved by FDA as an orphan drug. The letter by Dr. Charles Thomas, according to Vitaline, "seriously criticized the content and methods of the Duke study" and suggested that the study "becomes its use as an anti- competitive tool in the supplement marketplace." Vitaline suggested that Sigma-Tau's motivation is "to eliminate the Vitaline products" because they are priced much lower than Carnitor. Vitaline also asserted that it obtains its L- carnitine from "the same source" as Sigma-Tau. Sigma-Tau again complained to FDA in October that dietary supplement L-carnitine products are still being marketed with drug claims.