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Consumer Health Products Senior Editor
Washington DC, USA
17+ years of experience
HBW Insight
By Malcolm Spicer 09 Jul 2021
Supplement OWL advisory board members Guru Ramanathan and Russ Michelson answer HBW Insight questions about the site’s progress and the potential for mandatory registration for dietary supplements sold in the US.
HBW Insight
By Malcolm Spicer 22 Jun 2020
FDA and FTC continue adding to total each has made during novel coronavirus pandemic. FTC's latest include peroxide gel and licorice as treatments; FDA’s emphasizes in warnings that three businesses' tests were not approved for OTC sales or for home use.
HBW Insight
By Malcolm Spicer 17 Mar 2020
In addition to postponing NDAC meeting on food handler antiseptic drug products, FDA is suspending most inspections of foreign manufacturing facilities through April. Latest consumer health industry conferences cancelled or postponed are Consumer Healthcare Product Association and Informa Markets events.
Topic Coronavirus
HBW Insight
By Malcolm Spicer 27 Jan 2020
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
Topic Drug Review FDA OTC Drugs
HBW Insight
By Malcolm Spicer 06 Dec 2019
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.
Topic Dietary Supplements FDA
HBW Insight
By Malcolm Spicer 08 Nov 2019
"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.
Topic FDA Policy & Regulation
HBW Insight
By Malcolm Spicer 01 Nov 2019
Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.
Topic FDA Policy & Regulation
HBW Insight
By Malcolm Spicer 05 Jul 2019
"We seem to be headed toward a confusing, uneven, and potentially risky market in CBD products. This situation creates an opportunity for Congress to take action," say Joshua Sharfstein and Pieter Cohen in NEJM. Additionally, GW Pharma exec says FDA should reign in the "unfettered" production and sales of food and supplements containing CBD , hemp or other cannabis-based ingredients to prevent potential harm to consumers.
Topic FDA Policy & Regulation
HBW Insight
22 Jul 2022
HBW Insight
22 Jul 2022
HBW Insight
13 Jul 2022
HBW Insight
12 Jul 2022
HBW Insight
12 Jul 2022
HBW Insight
08 Jul 2022
HBW Insight
06 Jul 2022
HBW Insight
05 Jul 2022
HBW Insight
30 Jun 2022
HBW Insight
29 Jun 2022
Pink Sheet
29 Jun 2022
HBW Insight
23 Jun 2022
HBW Insight
22 Jun 2022
Medtech Insight
15 Jun 2022
HBW Insight
13 Jun 2022
