US FDA's Consumer Health Oversight Absent From Appropriators’ Request For COVID-19 Assessment
At 90 And Counting, Will Supplement Warnings Merit Mention In Response?
House appropriators don’t mention the consumer health market in requesting a report on FDA’s response to COVID-19, but the agency’s frequent warnings about products marketed with unlawful claims could merit mentioning. Encouraging accelerated production of hand sanitizers while also ensuring the additional supplies are safe is another component of its COVID-19 response that could be covered in an assessment of its response to the pandemic.
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The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.
FDA’s pause in facility inspections could prompt draft legislation for mandatory supplement product registration. It told industry groups it’s working on language for legislation to give it a better handle on products in the market and facilities with problems, says CRN head Steve Mister.
Appropriations subcommittee notes the funding in summary of its draft budget bill. Language on FDA’s development of CBD regulatory framework will be included in panel’s report to be released 24 hours before full committee’s markup.