PAYSON, Utah—Sabinsa Corp. , which supplies herbal extracts, cosmeceuticals, minerals and specialty fine chemicals, submitted comments to FDA on the agency's NDI draft guidance. The company echoed many of the industry's concerns about the potential great cost of requiring not just ingredients but also finished dietary supplements; it also replicated concerns about potential intellectual property issues. The comments also included many requests for clarification of aspects of the guidance, such as the documentation needed for grandfathering an ingredient and whether FDA expects the same safety information as is required for GRAS (generally recognized as safe) status—a question of absence of significant risk relative to reasonable certainty of no harm. As FDA indicated it considers the use of any solvents other than water and aqueous alcohol as chemical alteration, the company asked FDA for its position on food grade solvents listed as GRAS, such as carbon dioxide extraction.
Additional points brought up by Sabinsa's comments include FDA's hard line on synthetic versions of vitamins and minerals. "Synthetics are pure molecules with the exact chemical structure of naturally occurring substances," the company wrote. "Therefore, synthetics have the exact same health benefits and safety concerns as the substances found in nature. Synthetics are also an excellent alternative to ongoing issues with supply and sustainability of natural products."
Overall, Sabinsa expressed concern the implementation of the guidance, as-is, would stifle demand for innovative dietary supplements and lessen the health benefits the industry can offer consumers.
