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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

House Members Suggest Buying Some Supplements With Pre-Tax Savings

Eight GOP House members urge IRS to allow supplements labeled with approved health claims to be considered “medical expenses” eligible for payment with pre-tax health savings accounts beginning with tax year 2020.
Dietary Supplements Legislation

Direct Seller's CBD Supplement Recall Mandated, More Ranitidine, Tween Cosmetic Recalls

FDA's latest recalls records update includes Basic Reset CBD supplements and another 4,300 units of Tween Brands cosmetics containing colors made from banned dye. Recalls resulting from testing of ranitidine drugs reported by Dr. Reddy's.

Recalls OTC Drugs

Adulterated OTCs Reach Dollar Tree, Third-Party Test Lab Missed Problems

Warning links retailers to multiple manufacturers inspected after FDASIA in 2012 pointed FDA toward inspecting all ex-US firms supplying products available in US but that had yet to be inspected for compliance. Manufacturers also were placed on import alerts to prevent their products, including cosmetics as well as drugs, from reaching US.

FDA OTC Drugs

MSM Nutraceuticals Ends 'Drug' Production, Warned On Claims, Ingredients

MSM Nutraceuticals may opt to use contract manufactures to resume marketing MSM-containing products. When it does, the firm is warned not to label and market its “MSM Pain Gel" and "MSM Nasal Spray" products as drugs.

Dietary Supplements Enforcement

GMPs, DMHA Spell FDA Warning For Revital U International

Plano, TX, own-labeler's Smart Caps declared dietary ingredient "Octrodine," also known as 1,5-dimethylhexylamine, or DMHA. Revial's two responses failed to satisfy the agency's concerns about its GMP compliance.
Dietary Supplements FDA

Contract Manufacturer Swabplus Warned To Remediate Water, Computer Systems

Maker of single-dose topical swabs indicated for application to sores and open wounds asked o respond with information including a "thorough remediation plan to install and operate a suitable water system." FDA inspectors determined Swabplus didn't correct problem found in a 2016 inspection of failing to test incoming components.

Dietary Supplements FDA
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