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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

US Supplement Industry Left Waiting For Changes In FDA ‘Unified’ Food Programs Reorganization

“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.”

Consumer FDA

In Food Programs Restructuring, US FDA Has Designs On Clear Priorities, Chain Of Command

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.

Consumer Supply Chain

US Dietary Supplement Industry In 2023: Little New Expected In NDI Notification Enforcement

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.

Dietary Supplements Ingredients

US Consumer Health Industry In 2023: Mandatory Listing Has Supplement Sector’s Attention

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.

Dietary Supplements FDA

US FDA ‘Punt’ On Hemp Rulemaking Frustrates, Confuses Supplement Industry

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.

Cannabidiol CBD FDA

Is US Hemp Policy Heading For Farm Bill, Act III?

It could take next farm bill, on lawmakers’ 2023 to-do list, to extinguish inferno of disagreement between FDA and regulated industries over lawful use of hemp-based ingredients in supplements as well as food and non-drug topicals. Before 2018 bill de-scheduled hemp, 2014 bill expanded access to hemp for research.

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