Generics Bulletin is part 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

Malcolm Spicer, Managing Editor – US

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.

Latest From Malcolm Spicer

Goldman Sachs Gains 2 Board Seats With Burst Subscription Oral Care Investment

Series C investment of an undisclosed amount announced in early May follows $20m funding for the Los Angeles company from Volition Capital and angel investors.

Financing Commercial

Seattle Biologics Firm Offers COVID-19 ‘Vaccine’ OTC Before Warnings By State, Federal Agencies

When businesses rapidly pivot to offering consumer health products and services, they’re likely not contemplating compliance with FDA regulations. Recent warning letters are more proof COVID-19 represents opportunities for numerous businesses that aren’t prepared to follow or simply aren’t aware of FDA regulations.

Enforcement Dietary Supplements

Mississippi Herbal ‘Parasite Removal’ Store Gets Second Warning On Claims, GMPs In Three Years

Latest warning to Humaworm notes findings that FDA inspectors made in July 2019. FDA officials apparently have been in Humaworm’s facility since then, executing a search warrant in October and confiscating encapsulating machines, herbs, capsules, computers, and records.

FDA Enforcement

Altaire Recalled Millions Of OTC Eye Drops, Halted Production After Repeat GMP Problems Found

“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. Warning submitted in March said falsifying data was found in making batch release decisions related to whether certain sterile ophthalmic drugs contained viable microorganisms.

FDA OTC Drugs

Sales Of Injectable CBD Offered OTC In US Stop With Recall; ChapStick, Benefiber Also Recalled

Recent US consumer health and beauty product recalls also include three shades of lip moisturizer with sunscreen, made by Pfizer and marketed by GSK due to a packaging problem. A Florida firm recalled one lot of a CBD oil tincture after a state agency’s test found high lead levels.

Cannabidiol CBD Recalls

US False COVID-19 Claims Continue Climbing Along With Rate Of Virus’ Spread Globally

FTC nearly doubles its total of warnings on false and misleading COVID-19 claims for consumer health products with 50 announced on 21 May. WHO reported the same day that the largest number of COVID-19 cases, more than 106,000, were recorded in any 24-hour period during the pandemic.

Dietary Supplements Coronavirus COVID-19
See All
UsernamePublicRestriction

Register