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
“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.
Trump’s first-term public health appointees “were serious people doing serious work in a bipartisan nature,” but HHS Secretary Robert F. Kennedy and other current presidential advisors “are not serious people,” says Massachusetts’ Jake Auchincloss.
Among FDA's diversions from accepted practices is not going “through the bureaucracy” of advisory committees for experts’ input on potential changes to improve the safety and nutrition profile of food products, says Commissioner Martin Makary.
“It was a little hard to begin after the change or the reduction in force. We're doing everything we can to do an assessment, restore some services of individuals, and also try to rebuild the culture, because it is a great culture,” says FDA Commissioner Martin Makary during FDLI conference.
NAD says Amazentis didn’t substantiate cellular performance and muscle function claims for its supplements containing proprietary ingredient Mitropure but provided “a sufficiently reliable and reasonable basis” for “clinically proven to revitalize mitochondria.”
Same-day announcements of RFIs from HHS secretary cover nutrient review process for infant formula and Kennedy’s “10-to-1 deregulatory policy” as part of president’s “broader federal effort to reduce regulatory burdens and increase transparency.”