Cattle material in OTCs
This article was originally published in The Tan Sheet
An FDA proposed rule would prohibit the use of certain cattle materials in drugs and homeopathics to prevent the spread of bovine spongiform encephalopathy, according to a Federal Register notice published Jan. 12. The list of materials prohibited from use includes items such as the brain, skull, eyes and spinal cord from cattle 30 months and older. The notice points out homeopathic preparations and OTCs approved through the monograph process will be required to comply with the rule, even though they have not been approved through a new drug application. "Although FDA's database of these products is incomplete, some of them may contain cattle materials that would be prohibited under this proposed rule. The requirements proposed...apply to all drugs for humans, including those marketed without an approved application," the notice states. Comments on the proposed rule are due by March 13...
You may also be interested in...
A recent Department of Health and Human Services proposal to review regulations every 10 years may mean good things for the device industry, said David Hoffmeister, partner, Wilson Sonsini Goodrich & Rosati.
Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.