Regulatory Focus

FDA Clarifies Labeling Claims for Dietary Supplements

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

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Proposed Ruling Affects OTC Ophthalmic Drug Manufacturers

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

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CPSC Proposes CR Packaging for Minoxidil

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

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Aluminum Content Warnings Proposed for TPN Therapy Products

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

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FDA Reform Act Has Minimal Effect on Packaging

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.

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Compliance Guide Clarifies Rules for Iron Products

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

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ISO 11607 Changes

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