FDA plans to revise its regulatory requirements for the pregnancy section of pharmaceutical labeling. An advanced notice of proposed rulemaking will put forth "preliminary proposals for changing the current requirements and will invite comments on all aspects of the notice." This is a long-term action and FDA gave no timetable.
FDA also approved the use of a "healthy" label claim for certain cereal grain products such as enriched flour, enriched rice and bread, even though until now they could not be labeled "healthy" because many do not meet the 10% nutrient requirement.
Package labels for foods containing soluble fiber from psyllium-seed husks may include a claim that consumption of the product can reduce the risks of heart disease when part of a diet low in saturated fat and cholesterol, according to a ruling from the Food and Drug Administration that is effective immediately.
The Health Industry Manufacturers Assn. (HIMA) doesn't support the draft guidance on medical device labeling developed by the U.S. Food & Drug Administration's Center for Devices and Radiological Health (CDRH).