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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

First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

OTC Drugs Guidance Documents

NIH Office of Dietary Supplements Reimagined In First Five-Year Strategic Plan Since 2017

ODS recently published request for comments on 2025-2029 draft strategic plan, “Blueprint for a Coordinated Dietary Supplement Research Agenda at NIH.” Publication of draft for ODS’s first five-year plan since 2017-2021 corresponds with having its first permanent director since 2022.

Dietary Supplements Research & Development

US Consumer Health Q2 Earnings Preview: If Not For Headwinds, Tailwinds Would Be Trending

Analysts tracking consumer health product firms in the US anticipatevApril-June results lower than a year ago across most businesses. While some results will be lower on comparisons with strong growth in 2023, others will reflect a slow allergy season, retailers’ inventories remaining high as consumer spending slows or firms continuing to recover from supply chain problems.

Consumer Business Strategies

Chevron Deference Muted, Higher Volume Ahead For US Supplement Market Regulatory Questions

Attorneys discuss potential impacts on consumer health products industry from Supreme Court’s “Loper Bright” decision in June on litigation brought by two fisheries, Loper Bright v. Raimondo and Relentless v. Department of Commerce.

FDA Litigation

Petros’ ED Drug OTC Self-Selection Study Checks Nitrate Patient, ACNU Switch ‘Fail First’ Boxes

Study with 509 subjects conducted in Petros’ preparation of OTC switch application demonstrated 90.6% correct self-selection for participants using its web app technology and DFL and 57.3% correct by subjects using only DFL.

Prescription To OTC Switch Artificial Intelligence

US Warning Letter Summer Rerun: Delta-8 In Food Packaged Like Brands Popular With Children

Noting similar warnings a year ago, the FDA and FTC announce warnings to six more, part of a joint effort to stop sales of copycat food products containing delta-8 THC, saying companies selling these "illegal products are demonstrating complete neglect for consumer safety.”

Cannabidiol CBD Warning Letters
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