Malcolm Spicer

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

Recent Dose Miscalculating Experience In Canada

Canada’s shortage of children’s analgesic/antipyretic OTCs in 2022 as COVID-19 and seasonal flu virus combined to drive stockpiling by consumers. Some poison control centers and hospitals offered recommendations about modifying adult doses to pediatric use.

Supplement Firms Make Good Neighbors Knocking On State AGs’ Doors

“The first time we have a contact with them, if and when someone complains, is not because you're in trouble, but you already have a pre-existing relationship,” says former Maryland state AG Doug Gansler.

Gloomy Forecast For Cultivation Of Additional Hemp Legislation In Next Congress

“I think the Republican Congress is going to slow down all of what's called progress, for lack of a better word, toward having hemp be accessible to folks in all kinds of forms,” says Doug Gansler, former Maryland state AG and chair of Cadwalader, Wickersham & Taft LLP’s state AG practice.

FDA Checking Boxes On PREA Requirement Exposure For OTC Acetaminophen, Ibuprofen NDAs

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

Trump’s HHS Secretary Nominee Among Potential Political Pivots Pending For FDA

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

Vitaquest Floats Advantages For Chewable Supplements As Tide Rises For Gummies

“Many of our customers have been excited about it and decided to go that way. We just feel like, as gummies sort of take all the press, we might as well do our little part to say, ‘hey, look, there is a different way,’” says Terry Coyle, Vitaquest’s chief innovation officer.