AI's Present Matters More Than Its Imagined Future theatlantic.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from theatlantic.com Daily Mail and Mail on Sunday newspapers.
Trade groups slam DSHEA 2.0 proposal related to adverse events In this story, the Center for Science in the Public Interest and industry trade groups debate the merits of requiring manufacturers to report all adverse events associated with their dietary supplements. Also weighing in: a prominent Harvard Medical School professor who studies supplements, and an expert in adverse event management and regulatory compliance services.
Editor’s note: This is the third article in a series on proposed reforms to DSHEA by several consumer groups in a recent letter to Congress.
Some consumer advocacy groups want U.S. lawmakers to impose a new requirement that manufacturers of dietary supplements report to FDA all “adverse events” associated with their products.
April 16, 2021
id=share>Today, California’s Office of Environmental Health Hazards Assessment released a ground-breaking, peer-reviewed report concluding that synthetic food dyes negatively affect children’s behavior.
Such a comprehensive and rigorous assessment has never been undertaken before. The final health effects assessment provides authoritative validation of what multiple independent reviews already concluded: that synthetic food dyes can cause or exacerbate behavior problems in some children.
The peer-reviewed assessment used a state-of-the-art approach combining systematic reviews and evidence integration. To reach its conclusions, it integrated evidence from 27 clinical trials in humans, as well as studies of laboratory animals and other types of studies that shed light on how food dyes might exert effects on the body (including studies on cells and neurotransmitters). Clinical trials in humans are the most powerful type of scientific evidence.
Several consumer groups and industry trade organizations are in favor of a new requirement that dietary supplements be listed with FDA, highlighting an area where diverse stakeholders can find common ground related to modernization of DSHEA. Yet even within the dietary supplement industry, there remain divisions over the benefits of a mandatory product listing.
Editor’s note: This is the second article in a series on proposed reforms to DSHEA by several consumer groups in a recent letter to Congress.
Recent proposals by consumer groups to modernize the regulation of dietary supplements have drawn mixed reactions from industry trade organizations.