FDA Rejects Germanium NDI Submission
The following contains excerpts from a correspondence between Geranti Pharma, a Korean manufacturer of Germanium products, and the FDA. This occurred in November of 2002 following Geranti’s submission of a NDI for their germanium yeast product. Such correspondence clearly demonstrates the FDA’s continued resistance to letting germanium products for human consumption into the country. The complete document in PDF format can be examined at the link provided below.
Nov 13, 2002
Department of Health and Human Services
Food and Drug Administration
FDA has carefully considered the information in your submission, and the agency has significant concerns about the evidence on which you rely to support your conclusion that dietary supplements containing Geranti Bio-Ge, when used under the conditions recommended or suggested, will reasonably be expected to be safe. Specifically, FDA continues to have concerns about the use of germanium and germanium-containing compounds in dietary supplements and nothing in your submission provides a basis to conclude that germanium use is safe. Prolonged intake of products containing germanium has been reported to be associated with various adverse effects including renal dysfunction, anemia, myopathy, neurotoxicity, and nephrotoxicity in several human cases 1-4. The studies referenced in your notification are not sufficient to demonstrate that use of your Granti Bio-Ge would not cause the adverse effects noted in the literature to be associated with the intake of germanium.
For the reasons discussed above, the information in your submission does not provide an adequate basis to conclude that Geranti Bio-Ge, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe. Therefore, your product may be adulterated under 21 U.S.C. 342(f)(1)(B) as a dietary supplement that contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). See Source.
Copyright © 2005 Designed Nutritional Products. For questions or comments E-mail email@example.com