‘Undeniable Truth’ For US FDA Supplement Programs Director: 'So Much Noncompliance'
ODS Director Steven Tave says violative manufacturing processes and products remain common not because FDA isn’t enforcing its regulations. “I applaud those who stand behind their products, but can you stand with the same conviction behind every product on the market?” he said at regulatory summit organized by trade groups.
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Panel discussions and public comments during FDA public meeting show industry sees agency, as it stated in draft NDI notification guidances published in 2011 and 2016, is allowing little room for innovation through making new ingredients available for use in VMS products. FDA says immense growth of the VMS market since DSHEA passed shows numerous products available in US contain substances that haven't been notified to the FDA with proof showing they are dietary ingredients and are safe for use.
FDA's supplement programs office is increasing its outreach to work with other agencies, states, the industry, health care professionals and consumer groups to improve oversight of the industry. The agency also expects GMP inspections to improve with officials focused on certain product categories.
Regular under-reporting of serious adverse event reports has spurred FDA to have its good manufacturing practice inspectors review dietary supplement firms’ AERs and reporting practices, FDA’s Fabricant says. Key compliance issues can tip off the agency that a company may be falling short on reporting.