Rose Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Malcolm Spicer

Senior Editor, Consumer Health

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.
Advertisement
Set Alert for Articles By Malcolm Spicer

Latest From Malcolm Spicer

Medical Food Firm Stands Its Ground After FDA Repeats Recall Request

Primus Pharmaceuticals say an insert in packages of its Limbrel capsules prescribed to manage metabolic processes associated with osteoarthritis advises that the ingredient baicalin could cause the lung condition acute hypersensitive pneumonitis and elevated liver enzymes in users with allergies to the flavonoid.

Dietary Supplements Regulation

Amarin Not Giving Up On Omega-3 Trade Battle

Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.

Consumer Drug Approval Standards

Supreme Court Cosmetic, Food Decisions Shape Amarin's Appeal For Omega-3 Trade Inquiry

Amarin's petition to the Federal Circuit Court to direct ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs leans on Supreme Court decisions that compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information rendered a product an unapproved drug or represented false advertising.

Dietary Supplements Legal Issues

FDA's Tighter Targeting For GMP Inspections Still Leaves Consistency Gap

The number of facilities inspected for compliance with supplement GMP requirements is increasing annually as the agency meets targets set by FSMA, according to data the American Herbal Products Association presented during a webinar.

Dietary Supplements FDA

FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes

Latest steps by US FDA targeting tobacco-related health problems are a Nicotine Steering Committee, headed by Commissioner Gottlieb, and a public docket, including a meeting in January, for suggestions on how novel products could be evaluated as safe and effective NRTs.

Consumer Drug Approval Standards

GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA

Report to key US legislators could boost efforts to revamp approaches to making nonprescription ingredients available.

Consumer FDA
See All
Advertisement
UsernamePublicRestriction

Register