Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


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

MacuHealth Asserts ‘Rigorous Process’ In Research Supporting Claims, But No Bill Of Health From NAD

“MacuHealth believes challenged claims are thoroughly supported by the multitude of peer reviewed, published scientific studies” but NAD review on Vision Elements challenge finds firm’s research doesn’t support its claims.

Advertising, Marketing & Sales Enforcement

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

Ad Complaints Consumer

Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

Advisory Committees FDA

US FDA Electronic Drug Registrations Key For OTC Monograph Fees Plus Keeping Tabs On Products

FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.

Warning Letters OTC Drugs

JAMA Study Finds E-Cigarettes, More Than NRTs, Help With Smoking Cessation During Pregnancy

As authors of JAMA study say theirs and others' research might influence regulatory policy on e-cigarettes’ use in smoking cessation, FDA publishes latest batch of warnings to businesses selling the products without pre-market approval required from the agency.

‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance

Ad Complaints Dietary Supplements
See All