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

Perrigo Securities Class-Action Settlement Awards Attorneys’ Fees, Expenses Lower Than Requested

Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.

Brushing Up For Oral Care Market Share, US Startups Launch Brushes, Toothpastes, Whiteners

Laifen, Opalescence Moon, Lewie and quip are among US companies with recent launches to boost their oral care market shares. Recent launch by Arm & Hammer global oral care brand also targets driving growth in the category.

Kratom Industry Argues FDA Wants To Label All Products As Adverse Events Without Evidence

Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.

ACNU Switch And IND Exemption Final Rules Targeted For October In FDA Regulatory Goals

Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.

Consumer Health Launches: Viome, Liquid Core, NOW Offer Line Extensions To Chew On

Viome Life Sciences launches VRx MyBiotics Toothpaste & Gel to complete its Oral Health Solution system; Liquid Core Gum’s Edge Performance made with its Liquid Core and Flavor Wave properties and distributed in packaging developed using sustainable cardboard tubes; and NOW Health Group launches Omega-3 Gummy Chews and E-Sport Reaction supplements.

Evidence Challenging Safety Of Maternal Use Of Acetaminophen Amounts To ‘Speculation’ – Court

Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.