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

Revenue Drain Among Challenges For ACNU OTC Marketers From Simultaneous Rx Availability

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.

Statin In Technology-Assisted OTC Study May Be First To Take ‘Fail-First’ Step For ‘ACNU’ Switch

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

US FDA Doesn’t Budge On ‘ACNU’ Switch Requirements Questioned By OTC Industry

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

‘New Paradigm’ For US OTC Switches Dawns After More Than 12 Years With ‘ACNU’ Final Rule

FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.

Lumineux Mouthwash ‘Non-Toxic’ Claim Gets Adverse Reaction In Advertising Review

National Advertising Division found multiple faults with Oral Essentials’ evidence for claim, including that an in vitro study the firm conducted on “mouse cells is not dispositive of whether the same product would have any adverse effects on humans under real world conditions.”

USANA’s $205M Majority Stake In Hiya Brings ‘Kidsperience’ And Direct-To-Consumer Sales

Hiya has more than 200,000 customers in the direct-to-consumer channel, all using subscriptions ordered on the brand’s website, and plans to expand into online marketplaces and retail chains. The startup “offers a compelling subscription model with attractive margins, profitability, and strong cash flow generation,” says USANA CEO Jim Brown.