OTC warnings not prominent
This article was originally published in The Tan Sheet
A study examining "the conspicuousness and prominence of two required warnings on OTC pain relievers" suggests labels ineffectively communicate warnings about tamper evidence and child-resistance features. Researchers led by Laura Bix of the School of Packaging at Michigan State University found fewer than 20 percent of 61 participants looked at tamper evidence warnings on five OTC acetaminophen products. Fewer than half looked at child-resistant feature warnings, according to the March 30 study in the Proceedings of the National Academy of Sciences. Further, the warnings were the least legible part of the label, and brand name and claims were most legible. The findings suggest the warnings are not "prominent" or "conspicuous" as required by FDA regulations. However, researchers say consumers do not consider the warnings important and additional consumer education is needed
You may also be interested in...
The US FDA released five device-related close-out letters in March.
Governments around the world should designate all medicines as ‘priority essential products’, the IGBA has urged, as a surge in demand coinciding with a reduction in the number of flights and rising freight costs are making it more difficult for suppliers to meet global requirements amid the coronavirus pandemic.
In a letter to the medtech industry, the FDA’s William Maisel says the US agency will hold remote meetings with device makers and other stakeholders through the end of May. The FDA also extended due dates for marketing applications by 90 days.