Regulatory Focus

FDA proposes nine ways to distinguish between structure and function claims, which are legal, and disease claims, which are not.

Complaints prompt FDA to consider requiring new warnings on product labeling.

CPSC adopts a staff policy stating that droppers and sprayers must be child resistant and senior friendly.

Aluminum levels in total parenteral nutrition therapy products have triggered a proposed requirement.

The act speeds the approval process for changes to drugs, devices, and biologic manufacturing, among other things, but has little to say about labeling or packaging.

The document, published for small businesses, spells out how to comply with the new regulations for packaging drugs and supplements containing iron.