CRN RECOMMENDS MARKET WITHDRAWAL OF GERMANIUM PRODUCTS ABOVE 1 MG/DAY

CRN RECOMMENDS MARKET WITHDRAWAL OF GERMANIUM PRODUCTS ABOVE 1 MG/DAY, the association told FDA in a Nov. 30 letter. Council for Responsible Nutrition Technical Director Annette Dickinson, PhD, notified FDA that the association "is recommending that the industry discontinue marketing germanium products at levels exceeding estimated dietary intakes," which CRN estimates at about 1 mg per day. Dickinson said that the association found from a survey of its members that the "few members" that had been marketing germanium products "have either withdrawn the products from the market . . . or will do so in the very near future (by the end of the year)." The decision by companies to withdraw germanium products, Dickinson said, was based on a recommendation by the National Nutritional Foods Association and from concerns raised by FDA. NNFA announced in September that it was "strongly urging" its members to voluntarily remove products containing added germanium from the market. NNFA based the recommendation on recent reports in the medical literature of toxicity and kidney failure associated with ingestion of germanium products. The letter from CRN was in response to an Oct. 14 letter sent out by FDA surveying the industry on the presence of comfrey and germanium in currently marketed and former products. In its letter, FDA also applauded the initiatives taken by NNFA and the American Herbal Products Association, which placed comfrey on its restricted use list during the summer ("The Tan Sheet" July 19, In Brief). Dickinson noted that "all of the adverse reactions" discovered by the association in a review of the medical literature involved "large intakes of germanium compounds." She said that CRN found "no evidence of any problems relating to germanium levels within the range of estimated usual dietary intakes." In a "position statement" accompanying the letter to FDA, CRN reported that its literature search revealed that "at least 36 persons" since 1980 have suffered either kidney damage or failure, with four of the recent reports from Europe and the rest from Japan. The serious adverse effects, CRN noted, occurred in individuals who took "very large amounts of germanium (27 mg to 405 mg per day) over periods of months or years." In her letter to FDA, Dickinson said the agency refused CRN's request for information "regarding known reports of adverse reactions" from germanium use unless the association filed a Freedom of Information request. She said CRN filed an FoI request "but went ahead and prepared our own review of the literature [in order] to provide the necessary basis for a policy recommendation." CRN emphasized that it "is not endorsing the marketing of germanium, even at levels approximating estimated dietary intakes of about 1 mg per day." Noting that germanium "appears to have no known nutritional function in any species," CRN pointed out that the ingredient is a trace element that occurs "ubiquitously in the environment and therefore in foods." Studies done in the 1960s and 1970s, CRN said, indicated that dietary intake of the trace element was in the range of .4 mg to 1.5 mg a day. CRN said there is no evidence suggesting "any safety issues" with daily intakes at those levels. CRN pointed out that "most" of the adverse reactions occurred with the use of germanium dioxide. However, the four cases in Europe found in the literature involved use of germanium lactate citrate and "several" of the cases in Japan "were believed to involve" germanium sesquioxide, CRN said. Consequently, CRN said it was not limiting its recommendation to withdraw products containing more than 1 mg/day of germanium to "particular compounds." Citing "industry sources," CRN said that the sesquioxide compound is manufactured from germanium dioxide and that "several passes through the processing system are required to obtain full conversion." Addressing concerns that the adverse reactions may be related to inadequate processing, CRN noted that "if this were the case, and if the safety concern were limited to the dioxide, then the problem might be reduced to a matter of quality control." However, the association concluded: "It is not clear at this time whether the concern can be entirely limited to the dioxide." CRN's position statement also recommends that the AIDS community should be warned of the "potential hazards" from high intakes of germanium given that two of the recent cases in the medical literature involved individuals with HIV infection.