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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

FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.
Dietary Supplements Manufacturing

On CRN Challenge, Nexus Formulas Gets Lesson On Supporting Ad Claims For Supplements

So full of errors were the firm's online ads for its Plavinol supplement, the National Advertising Division noted support for some claims contained "many of the same flaws" as others. The prevalence of problems prompted NAD to go outside its "scope of review" and note unclear instructions on Plavinol labels.

Dietary Supplements Ad Complaints

Perrigo Returns To 'Model' For Success, Expects Surprises From 2020 Launches

Perrigo "walked away a little bit" from "a model that worked beautifully," says CEO Murray Kessler at investor conference, "In essence, all we've done over the last year is to put back in place the model that worked so well."

OTC Drugs Launches

Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

Dietary Supplements FDA

EPH Warned On Opioid Treatment Claim For Enzyme, Amino, Peptide Blend

EPH Technologies apparently heeds FDA's warning, which also noted violative drug and disease claims for nasal sprays. EPH continued selling other supplements on 2 December, but the three that FDAcited in 18 November warning were not available.

Enforcement Dietary Supplements

Complicated Regulatory Odyssey Steers FDA Toward Rule On CBD In Supplements

Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.
Dietary Supplements FDA
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