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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.

Latest From Malcolm Spicer

US Consumer Health And Beauty Recalls: High Lead In Hemp Oils, More Sanitizers With Methanol

While FDA continues posting announcements of recalls of hand sanitizers made by firms in Mexico and found to contain methanol, its latest recall records update also show Michigan Herbal Remedies recalled a total of 5,938 bottles of hemp oils due to elevated lead levels.

Recalls OTC Drugs

Compliance For ‘Gluten Free’ Claims For Fermented, Hydrolyzed Supplements Relies On Recordkeeping

Final rule amends FDA regulation on gluten-free labeling to provide alternative means for the agency to verify compliance. It will determine whether a firm is compliant from records it must maintain, and make available for inspection and copying, of the fermented or hydrolyzed supplements and food products bearing the claim.

FDA Dietary Supplements

US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance

The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.

Guidance Documents FDA

Included In Bausch’s Planned Spin-Off, Consumer Brands Account For 3 Spots In Its Top 10 List

Sales of its segment leaders Ocuvite and PreserVision vision health supplements, Lumify OTC eye drops and other consumer lines were down a reported 13% to $321m in the second quarter.

Commercial Consumer

With CBD Products Unlawful, FDA Enforcement Policy Guidance Has No Economic Significance

As draft guidance receives OMB review, FDA’s determination of no economic significance reflects its official position that the thousands of supplements, food and personal care products containing CBDs available in the US are unlawful.

Cannabidiol CBD Guidance Documents

US OTC Decisions In July: Labeling For Advil Sinus In 2-Count Packages, Lansoprazole, Ibuprofen

Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.

OTC Drugs Approvals
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