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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.
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Latest From Malcolm Spicer

Omega-3 Ingredients Fair Trade Complaint? Not FDA's Bailiwick, Amarin Says

The drug maker says it's not asking ITC to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.

Dietary Supplements Legal Issues

Second Warning, Second Unsafe Ingredient For Total Body Nutrition

FDA's Sept. 28 warning letter to Total Body Nutrition also noted violative claims and labeling for its products marketed with the TBN brand and listed GMP problems. First methylsynephrine in 2016, now DMAA land firm on FDA enforcement radar.

Dietary Supplements Cosmetic Ingredients

Kratom: All Questions On Pre-DSHEA Ingredient Evidence In One Package

"Kratom illustrates the promise and the peril of dietary supplement regulation," says Jack Henningfield, Pinney Associates consultant and an expert on abuse liability of various substances. Kratom firms agree NDI notifications are needed for ingredients made from separate kratom alkaloids, but say the botanical itself has decades of safe use in the US.

Dietary Supplements FDA

Controversy Brews With 'Inaccurate' Reports Linking Kratom To Deaths

American Kratom Association and independent researchers explain the ingredient's history of safe use in a media briefing. Medical examiners "have tried to pin on kratom" the recent deaths of men in Florida and New York, says trade group Chairman Dave Herman.

Dietary Supplements Regulation

FDA Plants Oversight Flag On Amarin Trade Claim Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

Dietary Supplements Cosmetic Ingredients

FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

Consumer Legal Issues
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