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

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

Longer ACNU Rule Review Gets Kennedy Signature

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

US Monograph Facility Fees Due In Six Weeks While DOGE Subjects FDA To Rapid Changes

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

‘Truly A Time Without Precedent’ Under Trump For Consumer Health Products Industry

“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”

US Supplement Industry Needs Relief From ‘Drug Preclusion’ Policy, CRN Reminds FDA

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.

ChromaDex Changing Name To Niagen Bioscience While Shifting Focus To Rx NAD+

A week after announcing 2024 full-year and fourth-quarter results, the firm says its corporate name will be Niagen Bioscience Inc. starting 19 March. It stated in its latest results that during 2024 it launched Niagen Plus line of pharmaceutical-grade Niagen.