States’ histories with legalizing cannabis aren’t good models for an hemp regulatory pathway, says FDA hemp and cannabis policy chief Norman Birenbaum. Influence from those models already seen in US with ingredients including delta-8 THC marketed as hemp as defined in federal law de-scheduling it as a controlled substance.

“Something needed to be done” to improve FDA’s regulation of human foods supply, says Commissioner Califf says. “Dietary supplements is a whole different kettle of fish that we can discuss at a later time.”

Following reviews prompted largely by formula supply crisis, FDA will move Center for Food Safety and Applied Nutrition and commissioner’s Office of Food Programs and Response to Human Foods Program headed by deputy commissioner. Office of Regulatory Affairs' structure also changing “to support the FDA organization as a whole,” says Commissioner Califf.

Chief executives of OTC drug and supplement industry trade groups discussed potential market and regulatory developments affecting their members’ businesses. HBW Insight concludes series here reporting on supplement sector’s outlook for FDA potentially resolving its protracted struggle with NDI notification requirement.

Chief executives of OTC drug and supplement industry trade groups discussed potential market and regulatory developments affecting their members’ businesses. HBW Insight reports here on whether support will emerge in Congress for FDA to gain MPL authority for all supplements sold in US.

Industry trade groups say FDA decision against starting rulemaking for lawful use of hemp ingredients is not only overdue but failed to clear the air for businesses making or using the ingredients.