The US Food and Drug Administration’s agency-wide reorganization could assuage dietary supplement industry stakeholders' concerns by keeping on its nomenclature an office focused on their products but also adding a separate enforcement unit.
US FDA Reorganization Branches Out Supplement Industry Regulation, Adds Enforcement Unit
OTC Drug Office Moved In CDER, Cosmetic Programs To Chief Scientist Office
Finished product following Reagan-Udall food safety programs review establishes Human Foods Program in commissioner’s office while also realigning centers, offices and divisions across agency to improve collaboration with regulatory affairs, which conducts facility inspections and other field operations.
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“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.
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CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
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Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
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UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”
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Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
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Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.