In Vivo is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Malcolm Spicer

Latest From Malcolm Spicer

Opioid Abuse Treatment Claims Prompt FDA Warnings To Two Kratom Marketers

As in previous warnings to kratom supplement marketers linked to opioid addiction treatment claims, FDA tells Cali Botanicals and Kratom NC that HHS in 2017 found opioid abuse was nationwide public health emergency and FDA is targeting products that without approval claim to diagnose, mitigate, prevent, treat or cure opioid addiction. Contract manufacturer Somlabs' GMP problems also were identified in FDA's latest warning letters.

United States US States

Herbalife Stretching Product Selection, Distributors Offer Customers More

Firms' US distributors deal with fewer customers because compensation no longer linked to recruiting multilevel networks of distributors. "The way you reached more customers is you signed one of your customers up as a rep, and they went and reached more, and that was the nature of the business model," says co-president John DeSimone. Today, distributors need larger variety of products to offer customers in the health, wellness and fitness space.

Dietary Supplements Commercial

FDA Appropriation Targets $100,000 To Find Safe CBD Level In Supplements

Rep. McNerneny's amendment calls for process that would follow steps FDA used in exercising enforcement discretion on natural products that contain levels of an approved drug ingredient, with red yeast rice most notable. But critics of FDA's VMS industry oversight don't see McNerney's amendment as effective not only for strengthening FDA's overall regulation but also for solving its CBD problem.

Dietary Supplements Legislation

Perrigo Pegs Growth To Initiating OTC Switches, Not Following Brands' NDAs

"A foundation of this business has been," says Perrigo's Americas consumer business chief, Jeffrey Needham, "we are a fast follower. That's been our traditional model. We can't afford to do that going forward." In addition to initiating moving ingredients from Rx to OTC, firm is developing "national better brand" versions of drugs already available OTC.

OTC Drugs Prescription To Otc Switch

Need Private Meeting For Sunscreen MUsT Details? Just Ask, FDA Says

"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."

OTC Drugs FDA

FDA Holds Line On Omega-3 Claims, But Gives Enforcement Discretion For More

Agency says "some credible evidence" suggests intake of  EPA and DHA "may reduce the risk of hypertension by lowering blood pressure, this evidence is inconclusive and highly inconsistent" and does not support actual approval of a qualified health claim.

See All
Advertisement
UsernamePublicRestriction

Register