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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.
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Latest From Malcolm Spicer

Shuttered US Supplement Firm Meets Recall Deadline, But Schumer Says FDA Late Cleaning Up Industry

While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.

Recalls Consumer

No Regulatory Imprimatur In UK For Scottish Firm’s Hangover Remedy Claim

Bounce Back Drinks sought to establish its bona fides as a registered consumer product provider, but statements referencing ASA, EFSA and MHRA imply the agencies reviewed and approved its product and advertising. Plus, hangover remedy claims are prohibited under UK regulations.

Dietary Supplements Ad Complaints

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

OTC Drugs FDA

FDA Action Items For CBD Policy? The List Is Short Due To 'Critical' Data Gaps

FDA has little in the way of good information it can list on its CBD policy agenda so far, says Principal Deputy Commissioner Amy Abernethy. At recent regulatory conference, she said, "Like it or not, there is a massive human experiment going on right now. There’s CBD in most different product categories and people of many different backgrounds with potential vulnerabilities taking CBD."

Dietary Supplements FDA

CBD Safety And Hemp Farming Have Equal Space In Rep. Harris’ Concerns

“We ought to deal with this. There are questions on long-term safety and questions on efficacy claims that are just not proven,” says the Maryland Republican. “The biggest threat hanging over, in my mind, the farmers who want to grow hemp, is what if the FDA comes out tomorrow and says, ‘You can't sell any product’? The market collapses,”he said at a CBD policy conference.

Dietary Supplements FDA

House Agriculture Chairman Plants Seeds For FDA's CBD Policy With First Bill

Minnesota Democrat Collin Peterson’s bill, the first targeting FDA’s CBD question, could provide an entire answer or it could set table for discussion in Congress about legislation on establishing an FDA regulation on using CBD, and potentially other hemp-derived substances, in products other than drugs subject to its oversight.

Dietary Supplements Legislation
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