Mandatory listing of all dietary supplements available in the US would be tantamount to pre-market approval, an authority neither included nor needed in the Food and Drug Administration’s regulatory toolbox, says American Herbal Products Association president Michael McGuffin.
AHPA Sees Pre-Market Approval Behind Legislation Titled ‘Mandatory Listing’ For Supplements In US
“FDA has all the authority it needs to enforce” regulations on supplement manufacturing, marketing and labeling, says AHPA president Michael McGuffin. “We're concerned that this will be a new pre-market registration requirement.”
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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At a recent European Parliament event, IPA Europe called on EU institutions to “prioritize proportional and coherent rules on the European probiotic food and food market, to ensure EU policies are fit for competitiveness.”
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“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.
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The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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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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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.”