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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

No End To US FDA Concerns About DEG And EG Testing, Or To OTC Firms Not Answering Its Calls

One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.

FDA OTC Drugs

Bausch + Lomb Spreads Into US Cosmetics Market, Extends Lumify Brand With Eye Illuminations Line

Canadian firm launches US sales of Lumify Eye Illuminations 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product contains hyaluronic acid, a fluid in eyes and joints which acts as a cushion and lubricant.

Cosmetics Launches

FTC Health Claims Guidance ‘Lacks Legal Basis,’ Conflicts With FDA’s Supplement Regulations – CRN

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

Ad Complaints Consumer

Good ‘Fit’ For Regulation Shifting US FDA's ODSP Into Larger Food Safety Program – Director

ODSP Director Cara Welch spoke about food programs structure and other supplement industry regulatory news days before first day on the job for agency’s first deputy commissioner for human foods, a post added in the human foods reorganization plan.

Dietary Supplements FDA

MacuHealth Asserts ‘Rigorous Process’ In Research Supporting Claims, But No Bill Of Health From NAD

“MacuHealth believes challenged claims are thoroughly supported by the multitude of peer reviewed, published scientific studies” but NAD review on Vision Elements challenge finds firm’s research doesn’t support its claims.

Advertising, Marketing & Sales Enforcement

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

Ad Complaints Consumer
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