US FDA's Decisions On 'Article' As Dietary Or Drug Ingredient: Level Playing Field?
Executive Summary
FDA drug center could hold more sway over which ingredients are allowed for use in supplements than center regulating supplement industry, suggests CRN CEO Steve Mister at a recent regulatory conference. ODSP second-in-command Gregory Noonan allows that agency has “vague” rule for “article” used in a supplement or a drug.
You may also be interested in...
Hemp Roundtable Says Safety Study Data Should Convince Congress On Lawful CBD Use
Study of 1,061 subjects showed oral CBD has robust safety profile, addressing FDA’s safety concerns and providing evidence to convince agency to take action on CBD regulation, say trade groups.
It’s Official: US Enforcement Discretion For NAC In Supplements, And Regulatory Options For FDA
Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug ingredient. However, NAC supplements, as they have remained since 2020, were available to US consumers when draft was published.
Red Yeast Rice History Offers Blueprint For Clearing CBD As Dietary Ingredient
Legal dispute between FDA and Pharmanex decided in 1999 could be precedent for using hemp-derived ingredients including CBD in supplements, even though CBD already has been authorized for clinical drug evaluation and for use in a drug, says attorney Miriam Guggenheim.