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
Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.
Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”
Result of firms marketing weight loss products to Black and Latino girls and to lower-income households is to “worsen health inequities by gender, race, ethnicity and income,” says Harvard researcher Bryn Austin, director of Strategic Training Initiative for the Prevention of Eating Disorders.
“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.