Food and Dietary Supplement Package Labeling-Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations.

Package labels for foods and dietary supplements must conform with Title 21 of the Code of Federal Regulations. This review provides guidance for the content and format of labels, including for the Nutrient Facts panel and Supplement Facts panel, and for drafting structure/function claims, health claims, and nutrient content claims. Also provided is guidance on how to refrain from drafting disease claims. Inappropriate disease claims on a food or dietary supplement compels FDA to review the product as a drug. Disease claims is the most common source of complaint in FDA's warning letters. This review makes use of all of FDA's warning letters that were published over a 14-y span (2002to 2015). This is the first comprehensive review on package labels to make use of FDA's warning letters as a source document.

Homeostatic mechanisms for iron storage revealed by genetic manipulations and live imaging of Drosophila ferritin.

Ferritin is a symmetric, 24-subunit iron-storage complex assembled of H and L chains. It is found in bacteria, plants, and animals and in two classes of mutations in the human L-chain gene, resulting in hereditary hyperferritinemia cataract syndrome or in neuroferritinopathy. Here, we examined systemic and cellular ferritin regulation and trafficking in the model organism Drosophila melanogaster. We showed that ferritin H and L transcripts are coexpressed during embryogenesis and that both subunits are essential for embryonic development. Ferritin overexpression impaired the survival of iron-deprived flies. In vivo expression of GFP-tagged holoferritin confirmed that iron-loaded ferritin molecules traffic through the Golgi organelle and are secreted into hemolymph. A constant ratio of ferritin H and L subunits, secured via tight post-transcriptional regulation, is characteristic of the secreted ferritin in flies. Differential cellular expression, conserved post-transcriptional regulation via the iron regulatory element, and distinct subcellular localization of the ferritin subunits prior to the assembly of holoferritin are all important steps mediating iron homeostasis. Our study revealed both conserved features and insect-specific adaptations of ferritin nanocages and provides novel imaging possibilities for their in vivo characterization.