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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

US DoJ Has 'Key Focus' On Supplement Industry, Adds 6 Attorneys To Sector

"It is just common sense that there's going to be fraud where you have the combination of high growth, developing science, imported products or ingredients and limited oversight," says David Morrell, deputy assistant US attorney in DoJ'd Consumer Protection Branch. CPB is adhering to executive order President Trump made earlier in 2019 instructing federal agencies to enforced based on regulations, not on guidance.
Dietary Supplements Enforcement

Supreme Court Doesn't Bite On Amarin Appeal In Omega-3 Fair Trade Complaint

The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.

Dietary Supplements Legal Issues

US Senate Passes First Monograph Reform Bill After House Passed Three

Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.

OTC Drugs FDA

More Ranitidine Products, Altaire Eye Drops Among Recent OTC Recalls

Recent updates to FDA recalls database also include single lots of three package sizes of Johnson’s Baby Powder after testing found sub-trace levels of chrysotile asbestos contamination and 5,720 bottles of homeopathic OTCs made in India for West Virginia firm Washington Homeopathic Products Inc. at a facility noncompliant with the agency’s good manufacturing practices regulations.

Recalls OTC Drugs

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
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